Protocol Index	

If this file opens in Compatibility Mode using Microsoft Word, convert to the latest document format to avoid potential formatting issues.	

OP RESEARCH PRO00037462 ADM00022216 PHASE 1 PART B ZHANG	

Types:      Research Oncology Treatment
Synonyms:  PD-L1

Cycle 1	Repeat 1 time	Cycle length: 28 days	Day 1	Perform every 1 day x1		Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Line Flush
  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Nursing Orders
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Radiological Assessment: 
o Scans may be obtained up to 6 weeks before the start of treatment.
o Radiological Assessments should then occur every 8 weeks (+/- 1 week) until disease progression, death, or lost to follow-up and for subjects without response or SD at end of treatment: within 7 days of end of treatment visit (only if the previous tumor scan has been performed GREATER than 4 weeks before the EoT visit). 
o Radiological assessments need to follow the original schedule, regardless of dose delays. 
o CR should be confirmed by repeated radiological evaluation between 4 to 6 weeks after the initial response assessment. PR confirmation within 4 to 8 weeks. 
o For subjects treated beyond progression, radiologic evaluation must be repeated in 4 to 8 weeks from initial scan showing progression.
			Provider Communication
  	ONC PROVIDER COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	eCrCl to be calculated from serum creatinine using the Cockcroft-Gault formula.
			Nursing Orders
  	ONC NURSING COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Abbreviated exam before dosing on D1 of every cycle must be performed by a physician or a qualified delegate. Must include and at minimum: 
o General appearance; 
o Skin (paleness, jaundice, redness/rash, acneiform changes); 
o Ears, eyes (jaundice, inflammation) nose, throat (presence of petechial bleedings, gingival bleeding); 
o Lungs; 
o Heart;  
o Abdomen (pain, tenderness, peristaltic, ascites, organomegaly); 
o Lymph nodes;  
o Extremities (petechial bleedings, ulcers, signs of thrombosis), hands and feet (signs of hand-foot syndrome/palmar-plantar erythrodysesthesia).
		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Abbreviated neurological examination to include the following assessments: 
o Section 1.14 Oculomotor testing, pupil accommodation, double images;  
o Section 1.15 Motor system: muscle strength of arms; 
o Section 1.16 Sensory system: pain and touch sensation of thighs; 
o Section 1.17 Mental Status (awareness of self and environment);  
o Section 1.18 Posture; 
o Section 1.19 Coordination: finger-to-nose and heel-to-shin test.
		  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	Other aspects/body parts or organ systems may be assessed at the Investigator's discretion.
		  	MEASURE WEIGHT	Interval: --	Occurrences: --	Comments:	Body weight measured before the start of treatment on C1D1 will be used to calculate the MT-6402 dose in all subsequent cycles. The dose must be recalculated when the body weight has changed by GREATER than or EQUAL to 10% from the baseline value; or according to institutional policies. Once a subject's weight changes by GREATER than or EQUAL to 10% and a new dose is administered, this weight is considered the new baseline. For subsequent cycles, this weight will be considered the new baseline to assess for changes in weight.
		  	ONC NURSING COMMUNICATION 8	Interval: --	Occurrences: --	Comments:	New York Heart Association: The classification of cardiac function will be performed for subjects with heart failure according to the NYHA (Section 10.6). Only applicable to subjects with heart failure.
		  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	ECOG
		  	ONC NURSING COMMUNICATION 10	Interval: --	Occurrences: --	Comments:	Adverse Event Review
		  	ONC NURSING COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	Concomitant Medication Review
			Nursing Orders
  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	o Triplicate 12-lead ECG. 
o Predose (LESS than or EQUAL to 4 hr prior to start of infusion); 
o 5 mins (+/- 5mins) after end of infusion; 
o 2 hrs (+/- 10mins) after end of infusion; 
o 4 hrs (+/- 10mins) after end of infusion.
			Imaging
  	TRANSTHORACIC ECHOCARDIOGRAM STRESS W DOP W CONT IF NEEDED	Interval: --	Occurrences: --	Comments:	o A pre-study LVEF assessment is acceptable if obtained within 28 days before starting study treatment. 
o Preferably full 3D ECHO or if not available, MUGA. The LVEF should be reported based on Simpson's biplane method. Results should be reported as a single value rather than a range. 
o During study: collected within 2 weeks before D1 dosing of every odd cycle (C3, C5, C7, etc).
			Nursing Orders
  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	o Measured after at least 5 mins of quiet rest in a sitting or semi-recumbant position
o Must include: BP (systolic and diastolic), respiratory rate, heart rate, body temperature
o When possible use the same body position and method of measurement of vital signs throughout a subject's participation in the study.
o C1D1: 
a. Pre-dose (any time prior to start of infusion); 
b. 0.5, 1, 2, 3, 4 hours after start of infusion.
			Labs
  	URINALYSIS, AUTOMATED WITH MICROSCOPY	Interval: --	Occurrences: --			Labs
  	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	Serum HCG 
Only applicable for WOCBP. Subjects who are postmenopausal (GREATER than 1 year since last menstrual cycle) or permanently sterilized (ie: bilateral tubal occlusion, hysterectomy,  bilateral salpingectomy) may be considered as not of reproductive potential. 
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --			Labs
  	AMYLASE LEVEL	Interval: --	Occurrences: --		  	LIPASE LEVEL	Interval: --	Occurrences: --			Labs
  	BILIRUBIN DIRECT	Interval: --	Occurrences: --			Labs
  	PHOSPHORUS LEVEL	Interval: --	Occurrences: --			Labs
  	URIC ACID LEVEL	Interval: --	Occurrences: --			Labs
  	LDH	Interval: --	Occurrences: --			Labs
  	CREATINE KINASE, TOTAL (CPK)	Interval: --	Occurrences: --	Comments:	Including isoenzymes, is > ULN
		  	C-REACTIVE PROTEIN	Interval: --	Occurrences: --		  	GGT	Interval: --	Occurrences: --		  	CORTISOL LEVEL, RANDOM	Interval: --	Occurrences: --		  	TSH AND FREE T4	Interval: --	Occurrences: --			Labs
  	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --		  	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Samples for PK must be drawn from a different line than that used for MT-6402 administration.
o Predose (</= 4 hr prior to start of infusion); 
o 5 mins (+/- 1min) after end of infusion; 
o 1 hr (+/- 5 mins) after end of infusion; 
o 2 hr (+/- 10 mins) after end of infusion; 
o 4 hrs (+/- 10 mins) after end of infusion; 
o 8 hrs (+/- 1 hr) after end of infusion.
			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mEq/L; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Treatment Conditions
  	TREATMENT CONDITIONS	Interval: --	Occurrences: --	Comments:	In the event of an unexplained clinically significant abnormal laboratory test value, the test should be repeated immediately and followed up until it has returned to the normal range and/or an adequate explanation of the abnormality is found. 
Laboratory test results will be graded according to the CTCAE v. 5.0 criteria. In general, a confirmed Grade 3 or Grade 4 abnormal laboratory test result is considered to be an AE and needs to be reported in the eCRF if at least 1 of the below criteria is met: 
1) The abnormality suggests a disease (except the disease under study) and/or organ toxicity; 
2) The abnormality is of a degree that requires active management; eg, change of dose, discontinuation of the drug, more frequent follow-up assessments, further diagnostic investigation, initiation of concomitant medication, etc. 
Confirmed Grade 2 abnormal laboratory results will be assessed on a case-by-case basis for clinical significance based upon the subject's baseline value screening, the duration of the abnormal result, the need for and type of treatment and/or further evaluation required. Abnormal laboratory test results meeting SAE criteria will be reported as such.
			Pre-Medications
  	ondansetron (ZOFRAN) 16 mg, dexAMETHasone (DECADRON) 12 mg in sodium chloride 0.9% 50 mL IVPB	Dose: 16 mg	Route: intravenous	once over 10 Minutes for 1 dose	Start: S			Ingredients:	Name	Type	Dose	Selected	Adds Vol.	ONDANSETRON HCL 2 MG/ML INTRAVENOUS SOLUTION	Medications	16 mg	Main Ingredient	No	DEXAMETHASONE SODIUM PHOSPHATE 10 MG/ML INJECTION SOLUTION	Medications	12 mg	Yes	No	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	Base	50 mL	Yes	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	Base	50 mL	No	Yes			  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	once for 1 dose	Start: S					Chemotherapy
  	ONC PROVIDER COMMUNICATION 3	Interval: --	Occurrences: --	Comments:	This schedule may be modified to Days 1, 8, and 15 or to Days 1 and 15 based on tolerability. MT-6402 doses may be administered within a 2-day window if deemed appropriate by the Investigator (protocol page 62). In Part B for subjects with clinical benefit (confirmed complete response [CR], partial response [PR] for at least 12 weeks, or stable disease [SD] for at least 24 weeks) and after agreement between the treating Investigator and the Medical Monitor, the treatment can be suspended for up to 8 weeks and later resumed if in the Investigator's opinion it is in the subject's best interest. The subject needs to attend the scheduled imaging assessment during the drug holiday.
		  	INV-MT-6402 IV (MT-6402-001/PRO00037462/ZHANG) ORDERABLE 16 mcg/kg (Treatment Plan)	Dose: 16 mcg/kg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer intravenously over 30 minutes (+/-5 minutes) using 0.2 micron inline filter for syringe and IV bag. Flush the line with NS so that the entire MT-6402 solution is administered to the patient.  Final concentration must be between 30-100mcg/mL. Prepared solution for infusion must be administered as soon as possible and within the same day. 
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.

			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only – itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Fexofenadine 180 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 – MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms – shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Fexofenadine 180 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	fexofenadine (ALLEGRA) tablet 180 mg	Dose: 180 mg	Route: oral	PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled				Day 2	Perform every 1 day x1		Provider Communication
  	ONC PROVIDER COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	eCrCl to be calculated from serum creatinine using the Cockcroft-Gault formula.
			Labs
  	C-REACTIVE PROTEIN	Interval: --	Occurrences: --			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Samples for PK must be drawn from a different line than that used for MT-6402 administration. 
o 24 hrs (+/- 8 hrs) after end of infusion.
			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --				Day 8	Perform every 1 day x1		Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Line Flush
  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Nursing Orders
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Provider Communication
  	ONC PROVIDER COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	eCrCl to be calculated from serum creatinine using the Cockcroft-Gault formula.
			Nursing Orders
  	ONC NURSING COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Abbreviated exam before dosing on D1 of every cycle must be performed by a physician or a qualified delegate. Must include and at minimum: 
o General appearance; 
o Skin (paleness, jaundice, redness/rash, acneiform changes); 
o Ears, eyes (jaundice, inflammation) nose, throat (presence of petechial bleedings, gingival bleeding); 
o Lungs; 
o Heart;  
o Abdomen (pain, tenderness, peristaltic, ascites, organomegaly); 
o Lymph nodes;  
o Extremities (petechial bleedings, ulcers, signs of thrombosis), hands and feet (signs of hand-foot syndrome/palmar-plantar erythrodysesthesia).
		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Abbreviated neurological examination to include the following assessments: 
o Section 1.14 Oculomotor testing, pupil accommodation, double images;  
o Section 1.15 Motor system: muscle strength of arms; 
o Section 1.16 Sensory system: pain and touch sensation of thighs; 
o Section 1.17 Mental Status (awareness of self and environment);  
o Section 1.18 Posture; 
o Section 1.19 Coordination: finger-to-nose and heel-to-shin test.
		  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	Other aspects/body parts or organ systems may be assessed at the Investigator's discretion.
		  	MEASURE WEIGHT	Interval: --	Occurrences: --	Comments:	Body weight measured before the start of treatment on C1D1 will be used to calculate the MT-6402 dose in all subsequent cycles. The dose must be recalculated when the body weight has changed by GREATER than or EQUAL to 10% from the baseline value; or according to institutional policies. Once a subject's weight changes by GREATER than or EQUAL to 10% and a new dose is administered, this weight is considered the new baseline. For subsequent cycles, this weight will be considered the new baseline to assess for changes in weight.
		  	ONC NURSING COMMUNICATION 8	Interval: --	Occurrences: --	Comments:	New York Heart Association: The classification of cardiac function will be performed for subjects with heart failure according to the NYHA (Section 10.6). Only applicable to subjects with heart failure.
		  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	ECOG
		  	ONC NURSING COMMUNICATION 10	Interval: --	Occurrences: --	Comments:	Adverse Event Review
		  	ONC NURSING COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	Concomitant Medication Review
			Nursing Orders
  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	o Triplicate 12-lead ECG. 
o Predose (LESS than or EQUAL to 4 hr prior to start of infusion); 
o 5 mins (+/- 5mins) after end of infusion; 
o 2 hrs (+/- 10mins) after end of infusion; 
o 4 hrs (+/- 10mins) after end of infusion.
			Nursing Orders
  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	o Measured after at least 5 mins of quiet rest in a sitting or semi-recumbant position
o Must include: BP (systolic and diastolic), respiratory rate, heart rate, body temperature
o When possible use the same body position and method of measurement of vital signs throughout a subject's participation in the study.
o All Cycles D8, D15, D22: 
a. Pre-dose (any time prior to start of infusion); 
b. 0.5, 1, 2 hours after start of infusion.
			Labs
  	URINALYSIS, AUTOMATED WITH MICROSCOPY	Interval: --	Occurrences: --			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --			Labs
  	AMYLASE LEVEL	Interval: --	Occurrences: --		  	LIPASE LEVEL	Interval: --	Occurrences: --			Labs
  	BILIRUBIN DIRECT	Interval: --	Occurrences: --			Labs
  	PHOSPHORUS LEVEL	Interval: --	Occurrences: --			Labs
  	URIC ACID LEVEL	Interval: --	Occurrences: --			Labs
  	LDH	Interval: --	Occurrences: --			Labs
  	CREATINE KINASE, TOTAL (CPK)	Interval: --	Occurrences: --	Comments:	Including isoenzymes, is > ULN
		  	GGT	Interval: --	Occurrences: --			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Samples for PK must be drawn from a different line than that used for MT-6402 administration.
o Predose (</= 4 hr prior to start of infusion); 
o 5 mins (+/- 1min) after end of infusion; 
o 1 hr (+/- 5 mins) after end of infusion; 
o 2 hr (+/- 10 mins) after end of infusion; 
o 4 hrs (+/- 10 mins) after end of infusion.
			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mEq/L; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Treatment Conditions
  	TREATMENT CONDITIONS	Interval: --	Occurrences: --	Comments:	In the event of an unexplained clinically significant abnormal laboratory test value, the test should be repeated immediately and followed up until it has returned to the normal range and/or an adequate explanation of the abnormality is found. 
Laboratory test results will be graded according to the CTCAE v. 5.0 criteria. In general, a confirmed Grade 3 or Grade 4 abnormal laboratory test result is considered to be an AE and needs to be reported in the eCRF if at least 1 of the below criteria is met: 
1) The abnormality suggests a disease (except the disease under study) and/or organ toxicity; 
2) The abnormality is of a degree that requires active management; eg, change of dose, discontinuation of the drug, more frequent follow-up assessments, further diagnostic investigation, initiation of concomitant medication, etc. 
Confirmed Grade 2 abnormal laboratory results will be assessed on a case-by-case basis for clinical significance based upon the subject's baseline value screening, the duration of the abnormal result, the need for and type of treatment and/or further evaluation required. Abnormal laboratory test results meeting SAE criteria will be reported as such.
			Pre-Medications
  	ondansetron (ZOFRAN) 16 mg, dexAMETHasone (DECADRON) 12 mg in sodium chloride 0.9% 50 mL IVPB	Dose: 16 mg	Route: intravenous	once over 10 Minutes for 1 dose	Start: S			Ingredients:	Name	Type	Dose	Selected	Adds Vol.	ONDANSETRON HCL 2 MG/ML INTRAVENOUS SOLUTION	Medications	16 mg	Main Ingredient	No	DEXAMETHASONE SODIUM PHOSPHATE 10 MG/ML INJECTION SOLUTION	Medications	12 mg	Yes	No	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	Base	50 mL	Yes	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	Base	50 mL	No	Yes			  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	once for 1 dose	Start: S					Chemotherapy
  	ONC PROVIDER COMMUNICATION 3	Interval: --	Occurrences: --	Comments:	This schedule may be modified to Days 1, 8, and 15 or to Days 1 and 15 based on tolerability. MT-6402 doses may be administered within a 2-day window if deemed appropriate by the Investigator (protocol page 62). In Part B for subjects with clinical benefit (confirmed complete response [CR], partial response [PR] for at least 12 weeks, or stable disease [SD] for at least 24 weeks) and after agreement between the treating Investigator and the Medical Monitor, the treatment can be suspended for up to 8 weeks and later resumed if in the Investigator's opinion it is in the subject's best interest. The subject needs to attend the scheduled imaging assessment during the drug holiday.
		  	INV-MT-6402 IV (MT-6402-001/PRO00037462/ZHANG) ORDERABLE 16 mcg/kg (Treatment Plan)	Dose: 16 mcg/kg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer intravenously over 30 minutes (+/-5 minutes) using 0.2 micron inline filter for syringe and IV bag. Flush the line with NS so that the entire MT-6402 solution is administered to the patient.  Final concentration must be between 30-100mcg/mL. Prepared solution for infusion must be administered as soon as possible and within the same day. 
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.

			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only – itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Fexofenadine 180 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 – MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms – shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Fexofenadine 180 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	fexofenadine (ALLEGRA) tablet 180 mg	Dose: 180 mg	Route: oral	PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled				Day 15	Perform every 1 day x1		Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Line Flush
  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Nursing Orders
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Provider Communication
  	ONC PROVIDER COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	eCrCl to be calculated from serum creatinine using the Cockcroft-Gault formula.
			Nursing Orders
  	ONC NURSING COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Abbreviated exam before dosing on D1 of every cycle must be performed by a physician or a qualified delegate. Must include and at minimum: 
o General appearance; 
o Skin (paleness, jaundice, redness/rash, acneiform changes); 
o Ears, eyes (jaundice, inflammation) nose, throat (presence of petechial bleedings, gingival bleeding); 
o Lungs; 
o Heart;  
o Abdomen (pain, tenderness, peristaltic, ascites, organomegaly); 
o Lymph nodes;  
o Extremities (petechial bleedings, ulcers, signs of thrombosis), hands and feet (signs of hand-foot syndrome/palmar-plantar erythrodysesthesia).
		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Abbreviated neurological examination to include the following assessments: 
o Section 1.14 Oculomotor testing, pupil accommodation, double images;  
o Section 1.15 Motor system: muscle strength of arms; 
o Section 1.16 Sensory system: pain and touch sensation of thighs; 
o Section 1.17 Mental Status (awareness of self and environment);  
o Section 1.18 Posture; 
o Section 1.19 Coordination: finger-to-nose and heel-to-shin test.
		  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	Other aspects/body parts or organ systems may be assessed at the Investigator's discretion.
		  	MEASURE WEIGHT	Interval: --	Occurrences: --	Comments:	Body weight measured before the start of treatment on C1D1 will be used to calculate the MT-6402 dose in all subsequent cycles. The dose must be recalculated when the body weight has changed by GREATER than or EQUAL to 10% from the baseline value; or according to institutional policies. Once a subject's weight changes by GREATER than or EQUAL to 10% and a new dose is administered, this weight is considered the new baseline. For subsequent cycles, this weight will be considered the new baseline to assess for changes in weight.
		  	ONC NURSING COMMUNICATION 8	Interval: --	Occurrences: --	Comments:	New York Heart Association: The classification of cardiac function will be performed for subjects with heart failure according to the NYHA (Section 10.6). Only applicable to subjects with heart failure.
		  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	ECOG
		  	ONC NURSING COMMUNICATION 10	Interval: --	Occurrences: --	Comments:	Adverse Event Review
		  	ONC NURSING COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	Concomitant Medication Review
			Nursing Orders
  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	o Triplicate 12-lead ECG. 
o Predose (LESS than or EQUAL to 4 hr prior to start of infusion); 
o 5 mins (+/- 5mins) after end of infusion; 
o 2 hrs (+/- 10mins) after end of infusion; 
o 4 hrs (+/- 10mins) after end of infusion.
			Nursing Orders
  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	o Measured after at least 5 mins of quiet rest in a sitting or semi-recumbant position
o Must include: BP (systolic and diastolic), respiratory rate, heart rate, body temperature
o When possible use the same body position and method of measurement of vital signs throughout a subject's participation in the study.
o All Cycles D8, D15, D22: 
a. Pre-dose (any time prior to start of infusion); 
b. 0.5, 1, 2 hours after start of infusion.
			Labs
  	URINALYSIS, AUTOMATED WITH MICROSCOPY	Interval: --	Occurrences: --			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --			Labs
  	AMYLASE LEVEL	Interval: --	Occurrences: --		  	LIPASE LEVEL	Interval: --	Occurrences: --			Labs
  	BILIRUBIN DIRECT	Interval: --	Occurrences: --			Labs
  	PHOSPHORUS LEVEL	Interval: --	Occurrences: --			Labs
  	URIC ACID LEVEL	Interval: --	Occurrences: --			Labs
  	LDH	Interval: --	Occurrences: --			Labs
  	CREATINE KINASE, TOTAL (CPK)	Interval: --	Occurrences: --	Comments:	Including isoenzymes, is > ULN
		  	C-REACTIVE PROTEIN	Interval: --	Occurrences: --		  	GGT	Interval: --	Occurrences: --			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Samples for PK must be drawn from a different line than that used for MT-6402 administration.
o Predose (</= 4 hr prior to start of infusion); 
o 5 mins (+/- 1min) after end of infusion; 
o 4 hrs (+/- 10 mins) after end of infusion.
			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Treatment Conditions
  	TREATMENT CONDITIONS	Interval: --	Occurrences: --	Comments:	In the event of an unexplained clinically significant abnormal laboratory test value, the test should be repeated immediately and followed up until it has returned to the normal range and/or an adequate explanation of the abnormality is found. 
Laboratory test results will be graded according to the CTCAE v. 5.0 criteria. In general, a confirmed Grade 3 or Grade 4 abnormal laboratory test result is considered to be an AE and needs to be reported in the eCRF if at least 1 of the below criteria is met: 
1) The abnormality suggests a disease (except the disease under study) and/or organ toxicity; 
2) The abnormality is of a degree that requires active management; eg, change of dose, discontinuation of the drug, more frequent follow-up assessments, further diagnostic investigation, initiation of concomitant medication, etc. 
Confirmed Grade 2 abnormal laboratory results will be assessed on a case-by-case basis for clinical significance based upon the subject's baseline value screening, the duration of the abnormal result, the need for and type of treatment and/or further evaluation required. Abnormal laboratory test results meeting SAE criteria will be reported as such.
			Pre-Medications
  	ondansetron (ZOFRAN) 16 mg, dexAMETHasone (DECADRON) 12 mg in sodium chloride 0.9% 50 mL IVPB	Dose: 16 mg	Route: intravenous	once over 10 Minutes for 1 dose	Start: S			Ingredients:	Name	Type	Dose	Selected	Adds Vol.	ONDANSETRON HCL 2 MG/ML INTRAVENOUS SOLUTION	Medications	16 mg	Main Ingredient	No	DEXAMETHASONE SODIUM PHOSPHATE 10 MG/ML INJECTION SOLUTION	Medications	12 mg	Yes	No	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	Base	50 mL	Yes	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	Base	50 mL	No	Yes			  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	once for 1 dose	Start: S					Chemotherapy
  	INV-MT-6402 IV (MT-6402-001/PRO00037462/ZHANG) ORDERABLE 16 mcg/kg (Treatment Plan)	Dose: 16 mcg/kg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer intravenously over 30 minutes (+/-5 minutes) using 0.2 micron inline filter for syringe and IV bag. Flush the line with NS so that the entire MT-6402 solution is administered to the patient.  Final concentration must be between 30-100mcg/mL. Prepared solution for infusion must be administered as soon as possible and within the same day. 
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.

			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only – itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Fexofenadine 180 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 – MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms – shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Fexofenadine 180 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	fexofenadine (ALLEGRA) tablet 180 mg	Dose: 180 mg	Route: oral	PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled				Day 22	Perform every 1 day x1		Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Line Flush
  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Nursing Orders
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Provider Communication
  	ONC PROVIDER COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	eCrCl to be calculated from serum creatinine using the Cockcroft-Gault formula.
			Nursing Orders
  	ONC NURSING COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Abbreviated exam before dosing on D1 of every cycle must be performed by a physician or a qualified delegate. Must include and at minimum: 
o General appearance; 
o Skin (paleness, jaundice, redness/rash, acneiform changes); 
o Ears, eyes (jaundice, inflammation) nose, throat (presence of petechial bleedings, gingival bleeding); 
o Lungs; 
o Heart;  
o Abdomen (pain, tenderness, peristaltic, ascites, organomegaly); 
o Lymph nodes;  
o Extremities (petechial bleedings, ulcers, signs of thrombosis), hands and feet (signs of hand-foot syndrome/palmar-plantar erythrodysesthesia).
		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Abbreviated neurological examination to include the following assessments: 
o Section 1.14 Oculomotor testing, pupil accommodation, double images;  
o Section 1.15 Motor system: muscle strength of arms; 
o Section 1.16 Sensory system: pain and touch sensation of thighs; 
o Section 1.17 Mental Status (awareness of self and environment);  
o Section 1.18 Posture; 
o Section 1.19 Coordination: finger-to-nose and heel-to-shin test.
		  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	Other aspects/body parts or organ systems may be assessed at the Investigator's discretion.
		  	MEASURE WEIGHT	Interval: --	Occurrences: --	Comments:	Body weight measured before the start of treatment on C1D1 will be used to calculate the MT-6402 dose in all subsequent cycles. The dose must be recalculated when the body weight has changed by GREATER than or EQUAL to 10% from the baseline value; or according to institutional policies. Once a subject's weight changes by GREATER than or EQUAL to 10% and a new dose is administered, this weight is considered the new baseline. For subsequent cycles, this weight will be considered the new baseline to assess for changes in weight.
		  	ONC NURSING COMMUNICATION 8	Interval: --	Occurrences: --	Comments:	New York Heart Association: The classification of cardiac function will be performed for subjects with heart failure according to the NYHA (Section 10.6). Only applicable to subjects with heart failure.
		  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	ECOG
		  	ONC NURSING COMMUNICATION 10	Interval: --	Occurrences: --	Comments:	Adverse Event Review
		  	ONC NURSING COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	Concomitant Medication Review
			Nursing Orders
  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	o Triplicate 12-lead ECG. 
o Predose (LESS than or EQUAL to 4 hr prior to start of infusion); 
o 5 mins (+/- 5mins) after end of infusion; 
o 2 hrs (+/- 10mins) after end of infusion; 
o 4 hrs (+/- 10mins) after end of infusion.
			Nursing Orders
  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	o Measured after at least 5 mins of quiet rest in a sitting or semi-recumbant position
o Must include: BP (systolic and diastolic), respiratory rate, heart rate, body temperature
o When possible use the same body position and method of measurement of vital signs throughout a subject's participation in the study.
o All Cycles D8, D15, D22: 
a. Pre-dose (any time prior to start of infusion); 
b. 0.5, 1, 2 hours after start of infusion.
			Labs
  	URINALYSIS, AUTOMATED WITH MICROSCOPY	Interval: --	Occurrences: --			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --			Labs
  	AMYLASE LEVEL	Interval: --	Occurrences: --		  	LIPASE LEVEL	Interval: --	Occurrences: --			Labs
  	BILIRUBIN DIRECT	Interval: --	Occurrences: --			Labs
  	PHOSPHORUS LEVEL	Interval: --	Occurrences: --			Labs
  	URIC ACID LEVEL	Interval: --	Occurrences: --			Labs
  	LDH	Interval: --	Occurrences: --			Labs
  	CREATINE KINASE, TOTAL (CPK)	Interval: --	Occurrences: --	Comments:	Including isoenzymes, is > ULN
		  	GGT	Interval: --	Occurrences: --			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Samples for PK must be drawn from a different line than that used for MT-6402 administration.
o Predose (</= 4 hr prior to start of infusion); 
o 5 mins (+/- 1min) after end of infusion; 
o 4 hrs (+/- 10 mins) after end of infusion.
			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Treatment Conditions
  	TREATMENT CONDITIONS	Interval: --	Occurrences: --	Comments:	In the event of an unexplained clinically significant abnormal laboratory test value, the test should be repeated immediately and followed up until it has returned to the normal range and/or an adequate explanation of the abnormality is found. 
Laboratory test results will be graded according to the CTCAE v. 5.0 criteria. In general, a confirmed Grade 3 or Grade 4 abnormal laboratory test result is considered to be an AE and needs to be reported in the eCRF if at least 1 of the below criteria is met: 
1) The abnormality suggests a disease (except the disease under study) and/or organ toxicity; 
2) The abnormality is of a degree that requires active management; eg, change of dose, discontinuation of the drug, more frequent follow-up assessments, further diagnostic investigation, initiation of concomitant medication, etc. 
Confirmed Grade 2 abnormal laboratory results will be assessed on a case-by-case basis for clinical significance based upon the subject's baseline value screening, the duration of the abnormal result, the need for and type of treatment and/or further evaluation required. Abnormal laboratory test results meeting SAE criteria will be reported as such.
			Pre-Medications
  	ondansetron (ZOFRAN) 16 mg, dexAMETHasone (DECADRON) 12 mg in sodium chloride 0.9% 50 mL IVPB	Dose: 16 mg	Route: intravenous	once over 10 Minutes for 1 dose	Start: S			Ingredients:	Name	Type	Dose	Selected	Adds Vol.	ONDANSETRON HCL 2 MG/ML INTRAVENOUS SOLUTION	Medications	16 mg	Main Ingredient	No	DEXAMETHASONE SODIUM PHOSPHATE 10 MG/ML INJECTION SOLUTION	Medications	12 mg	Yes	No	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	Base	50 mL	Yes	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	Base	50 mL	No	Yes			  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	once for 1 dose	Start: S					Chemotherapy
  	INV-MT-6402 IV (MT-6402-001/PRO00037462/ZHANG) ORDERABLE 16 mcg/kg (Treatment Plan)	Dose: 16 mcg/kg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer intravenously over 30 minutes (+/-5 minutes) using 0.2 micron inline filter for syringe and IV bag. Flush the line with NS so that the entire MT-6402 solution is administered to the patient.  Final concentration must be between 30-100mcg/mL. Prepared solution for infusion must be administered as soon as possible and within the same day. 
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.

			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only – itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Fexofenadine 180 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 – MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms – shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Fexofenadine 180 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	fexofenadine (ALLEGRA) tablet 180 mg	Dose: 180 mg	Route: oral	PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled					
Cycle 2	Repeat 1 time	Cycle length: 28 days	Day 1	Perform every 1 day x1		Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Line Flush
  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Nursing Orders
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Provider Communication
  	ONC PROVIDER COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	eCrCl to be calculated from serum creatinine using the Cockcroft-Gault formula.
			Nursing Orders
  	ONC NURSING COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Abbreviated exam before dosing on D1 of every cycle must be performed by a physician or a qualified delegate. Must include and at minimum: 
o General appearance; 
o Skin (paleness, jaundice, redness/rash, acneiform changes); 
o Ears, eyes (jaundice, inflammation) nose, throat (presence of petechial bleedings, gingival bleeding); 
o Lungs; 
o Heart;  
o Abdomen (pain, tenderness, peristaltic, ascites, organomegaly); 
o Lymph nodes;  
o Extremities (petechial bleedings, ulcers, signs of thrombosis), hands and feet (signs of hand-foot syndrome/palmar-plantar erythrodysesthesia).
		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Abbreviated neurological examination to include the following assessments: 
o Section 1.14 Oculomotor testing, pupil accommodation, double images;  
o Section 1.15 Motor system: muscle strength of arms; 
o Section 1.16 Sensory system: pain and touch sensation of thighs; 
o Section 1.17 Mental Status (awareness of self and environment);  
o Section 1.18 Posture; 
o Section 1.19 Coordination: finger-to-nose and heel-to-shin test.
		  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	Other aspects/body parts or organ systems may be assessed at the Investigator's discretion.
		  	MEASURE WEIGHT	Interval: --	Occurrences: --	Comments:	Body weight measured before the start of treatment on C1D1 will be used to calculate the MT-6402 dose in all subsequent cycles. The dose must be recalculated when the body weight has changed by GREATER than or EQUAL to 10% from the baseline value; or according to institutional policies. Once a subject's weight changes by GREATER than or EQUAL to 10% and a new dose is administered, this weight is considered the new baseline. For subsequent cycles, this weight will be considered the new baseline to assess for changes in weight.
		  	ONC NURSING COMMUNICATION 8	Interval: --	Occurrences: --	Comments:	New York Heart Association: The classification of cardiac function will be performed for subjects with heart failure according to the NYHA (Section 10.6). Only applicable to subjects with heart failure.
		  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	ECOG
		  	ONC NURSING COMMUNICATION 10	Interval: --	Occurrences: --	Comments:	Adverse Event Review
		  	ONC NURSING COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	Concomitant Medication Review
			Nursing Orders
  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	o Triplicate 12-lead ECG. 
o Predose (LESS than or EQUAL to 4 hr prior to start of infusion); 
o 5 mins (+/- 5mins) after end of infusion; 
o 2 hrs (+/- 10mins) after end of infusion; 
o 4 hrs (+/- 10mins) after end of infusion.
			Nursing Orders
  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	o Measured after at least 5 mins of quiet rest in a sitting or semi-recumbant position
o Must include: BP (systolic and diastolic), respiratory rate, heart rate, body temperature
o When possible use the same body position and method of measurement of vital signs throughout a subject's participation in the study.
o C2D1: 
a. Pre-dose (any time prior to start of infusion); 
b. 0.5, 1, 2 hours after start of infusion.
			Labs
  	URINALYSIS, AUTOMATED WITH MICROSCOPY	Interval: --	Occurrences: --			Labs
  	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	Serum HCG 
Only applicable for WOCBP. Subjects who are postmenopausal (GREATER than 1 year since last menstrual cycle) or permanently sterilized (ie: bilateral tubal occlusion, hysterectomy,  bilateral salpingectomy) may be considered as not of reproductive potential. 
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --			Labs
  	AMYLASE LEVEL	Interval: --	Occurrences: --		  	LIPASE LEVEL	Interval: --	Occurrences: --			Labs
  	BILIRUBIN DIRECT	Interval: --	Occurrences: --			Labs
  	PHOSPHORUS LEVEL	Interval: --	Occurrences: --			Labs
  	URIC ACID LEVEL	Interval: --	Occurrences: --			Labs
  	LDH	Interval: --	Occurrences: --			Labs
  	CREATINE KINASE, TOTAL (CPK)	Interval: --	Occurrences: --	Comments:	Including isoenzymes, is > ULN
		  	C-REACTIVE PROTEIN	Interval: --	Occurrences: --		  	GGT	Interval: --	Occurrences: --		  	CORTISOL LEVEL, RANDOM	Interval: --	Occurrences: --		  	TSH AND FREE T4	Interval: --	Occurrences: --			Labs
  	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --		  	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Samples for PK must be drawn from a different line than that used for MT-6402 administration.
o Predose (</= 4 hr prior to start of infusion); 
o 5 mins (+/- 1min) after end of infusion; 
o 4 hrs (+/- 10 mins) after end of infusion.
			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mEq/L; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Treatment Conditions
  	TREATMENT CONDITIONS	Interval: --	Occurrences: --	Comments:	In the event of an unexplained clinically significant abnormal laboratory test value, the test should be repeated immediately and followed up until it has returned to the normal range and/or an adequate explanation of the abnormality is found. 
Laboratory test results will be graded according to the CTCAE v. 5.0 criteria. In general, a confirmed Grade 3 or Grade 4 abnormal laboratory test result is considered to be an AE and needs to be reported in the eCRF if at least 1 of the below criteria is met: 
1) The abnormality suggests a disease (except the disease under study) and/or organ toxicity; 
2) The abnormality is of a degree that requires active management; eg, change of dose, discontinuation of the drug, more frequent follow-up assessments, further diagnostic investigation, initiation of concomitant medication, etc. 
Confirmed Grade 2 abnormal laboratory results will be assessed on a case-by-case basis for clinical significance based upon the subject's baseline value screening, the duration of the abnormal result, the need for and type of treatment and/or further evaluation required. Abnormal laboratory test results meeting SAE criteria will be reported as such.
			Pre-Medications
  	ondansetron (ZOFRAN) 16 mg, dexAMETHasone (DECADRON) 12 mg in sodium chloride 0.9% 50 mL IVPB	Dose: 16 mg	Route: intravenous	once over 10 Minutes for 1 dose	Start: S			Ingredients:	Name	Type	Dose	Selected	Adds Vol.	ONDANSETRON HCL 2 MG/ML INTRAVENOUS SOLUTION	Medications	16 mg	Main Ingredient	No	DEXAMETHASONE SODIUM PHOSPHATE 10 MG/ML INJECTION SOLUTION	Medications	12 mg	Yes	No	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	Base	50 mL	Yes	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	Base	50 mL	No	Yes			  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	once for 1 dose	Start: S					Chemotherapy
  	ONC PROVIDER COMMUNICATION 3	Interval: --	Occurrences: --	Comments:	This schedule may be modified to Days 1, 8, and 15 or to Days 1 and 15 based on tolerability. MT-6402 doses may be administered within a 2-day window if deemed appropriate by the Investigator (protocol page 62). In Part B for subjects with clinical benefit (confirmed complete response [CR], partial response [PR] for at least 12 weeks, or stable disease [SD] for at least 24 weeks) and after agreement between the treating Investigator and the Medical Monitor, the treatment can be suspended for up to 8 weeks and later resumed if in the Investigator's opinion it is in the subject's best interest. The subject needs to attend the scheduled imaging assessment during the drug holiday.
		  	INV-MT-6402 IV (MT-6402-001/PRO00037462/ZHANG) ORDERABLE 16 mcg/kg (Treatment Plan)	Dose: 16 mcg/kg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer intravenously over 30 minutes (+/-5 minutes) using 0.2 micron inline filter for syringe and IV bag. Flush the line with NS so that the entire MT-6402 solution is administered to the patient.  Final concentration must be between 30-100mcg/mL. Prepared solution for infusion must be administered as soon as possible and within the same day. 
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.

			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only – itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Fexofenadine 180 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 – MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms – shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Fexofenadine 180 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	fexofenadine (ALLEGRA) tablet 180 mg	Dose: 180 mg	Route: oral	PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled				Day 8	Perform every 1 day x1		Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Line Flush
  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Nursing Orders
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Provider Communication
  	ONC PROVIDER COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	eCrCl to be calculated from serum creatinine using the Cockcroft-Gault formula.
			Nursing Orders
  	ONC NURSING COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Abbreviated exam before dosing on D1 of every cycle must be performed by a physician or a qualified delegate. Must include and at minimum: 
o General appearance; 
o Skin (paleness, jaundice, redness/rash, acneiform changes); 
o Ears, eyes (jaundice, inflammation) nose, throat (presence of petechial bleedings, gingival bleeding); 
o Lungs; 
o Heart;  
o Abdomen (pain, tenderness, peristaltic, ascites, organomegaly); 
o Lymph nodes;  
o Extremities (petechial bleedings, ulcers, signs of thrombosis), hands and feet (signs of hand-foot syndrome/palmar-plantar erythrodysesthesia).
		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Abbreviated neurological examination to include the following assessments: 
o Section 1.14 Oculomotor testing, pupil accommodation, double images;  
o Section 1.15 Motor system: muscle strength of arms; 
o Section 1.16 Sensory system: pain and touch sensation of thighs; 
o Section 1.17 Mental Status (awareness of self and environment);  
o Section 1.18 Posture; 
o Section 1.19 Coordination: finger-to-nose and heel-to-shin test.
		  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	Other aspects/body parts or organ systems may be assessed at the Investigator's discretion.
		  	MEASURE WEIGHT	Interval: --	Occurrences: --	Comments:	Body weight measured before the start of treatment on C1D1 will be used to calculate the MT-6402 dose in all subsequent cycles. The dose must be recalculated when the body weight has changed by GREATER than or EQUAL to 10% from the baseline value; or according to institutional policies. Once a subject's weight changes by GREATER than or EQUAL to 10% and a new dose is administered, this weight is considered the new baseline. For subsequent cycles, this weight will be considered the new baseline to assess for changes in weight.
		  	ONC NURSING COMMUNICATION 8	Interval: --	Occurrences: --	Comments:	New York Heart Association: The classification of cardiac function will be performed for subjects with heart failure according to the NYHA (Section 10.6). Only applicable to subjects with heart failure.
		  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	ECOG
		  	ONC NURSING COMMUNICATION 10	Interval: --	Occurrences: --	Comments:	Adverse Event Review
		  	ONC NURSING COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	Concomitant Medication Review
			Nursing Orders
  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	o Triplicate 12-lead ECG. 
o Predose (LESS than or EQUAL to 4 hr prior to start of infusion); 
o 5 mins (+/- 5mins) after end of infusion; 
o 2 hrs (+/- 10mins) after end of infusion; 
o 4 hrs (+/- 10mins) after end of infusion.
			Nursing Orders
  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	o Measured after at least 5 mins of quiet rest in a sitting or semi-recumbant position
o Must include: BP (systolic and diastolic), respiratory rate, heart rate, body temperature
o When possible use the same body position and method of measurement of vital signs throughout a subject's participation in the study.
o All Cycles D8, D15, D22: 
a. Pre-dose (any time prior to start of infusion); 
b. 0.5, 1, 2 hours after start of infusion.
			Labs
  	URINALYSIS, AUTOMATED WITH MICROSCOPY	Interval: --	Occurrences: --			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --			Labs
  	AMYLASE LEVEL	Interval: --	Occurrences: --		  	LIPASE LEVEL	Interval: --	Occurrences: --			Labs
  	BILIRUBIN DIRECT	Interval: --	Occurrences: --			Labs
  	PHOSPHORUS LEVEL	Interval: --	Occurrences: --			Labs
  	URIC ACID LEVEL	Interval: --	Occurrences: --			Labs
  	LDH	Interval: --	Occurrences: --			Labs
  	CREATINE KINASE, TOTAL (CPK)	Interval: --	Occurrences: --	Comments:	Including isoenzymes, is > ULN
		  	GGT	Interval: --	Occurrences: --			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mEq/L; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Treatment Conditions
  	TREATMENT CONDITIONS	Interval: --	Occurrences: --	Comments:	In the event of an unexplained clinically significant abnormal laboratory test value, the test should be repeated immediately and followed up until it has returned to the normal range and/or an adequate explanation of the abnormality is found. 
Laboratory test results will be graded according to the CTCAE v. 5.0 criteria. In general, a confirmed Grade 3 or Grade 4 abnormal laboratory test result is considered to be an AE and needs to be reported in the eCRF if at least 1 of the below criteria is met: 
1) The abnormality suggests a disease (except the disease under study) and/or organ toxicity; 
2) The abnormality is of a degree that requires active management; eg, change of dose, discontinuation of the drug, more frequent follow-up assessments, further diagnostic investigation, initiation of concomitant medication, etc. 
Confirmed Grade 2 abnormal laboratory results will be assessed on a case-by-case basis for clinical significance based upon the subject's baseline value screening, the duration of the abnormal result, the need for and type of treatment and/or further evaluation required. Abnormal laboratory test results meeting SAE criteria will be reported as such.
			Pre-Medications
  	ondansetron (ZOFRAN) 16 mg, dexAMETHasone (DECADRON) 12 mg in sodium chloride 0.9% 50 mL IVPB	Dose: 16 mg	Route: intravenous	once over 10 Minutes for 1 dose	Start: S			Ingredients:	Name	Type	Dose	Selected	Adds Vol.	ONDANSETRON HCL 2 MG/ML INTRAVENOUS SOLUTION	Medications	16 mg	Main Ingredient	No	DEXAMETHASONE SODIUM PHOSPHATE 10 MG/ML INJECTION SOLUTION	Medications	12 mg	Yes	No	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	Base	50 mL	Yes	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	Base	50 mL	No	Yes			  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	once for 1 dose	Start: S					Chemotherapy
  	ONC PROVIDER COMMUNICATION 3	Interval: --	Occurrences: --	Comments:	This schedule may be modified to Days 1, 8, and 15 or to Days 1 and 15 based on tolerability. MT-6402 doses may be administered within a 2-day window if deemed appropriate by the Investigator (protocol page 62). In Part B for subjects with clinical benefit (confirmed complete response [CR], partial response [PR] for at least 12 weeks, or stable disease [SD] for at least 24 weeks) and after agreement between the treating Investigator and the Medical Monitor, the treatment can be suspended for up to 8 weeks and later resumed if in the Investigator's opinion it is in the subject's best interest. The subject needs to attend the scheduled imaging assessment during the drug holiday.
		  	INV-MT-6402 IV (MT-6402-001/PRO00037462/ZHANG) ORDERABLE 16 mcg/kg (Treatment Plan)	Dose: 16 mcg/kg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer intravenously over 30 minutes (+/-5 minutes) using 0.2 micron inline filter for syringe and IV bag. Flush the line with NS so that the entire MT-6402 solution is administered to the patient.  Final concentration must be between 30-100mcg/mL. Prepared solution for infusion must be administered as soon as possible and within the same day. 
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.

			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only – itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Fexofenadine 180 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 – MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms – shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Fexofenadine 180 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	fexofenadine (ALLEGRA) tablet 180 mg	Dose: 180 mg	Route: oral	PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled				Day 15	Perform every 1 day x1		Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Line Flush
  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Nursing Orders
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Provider Communication
  	ONC PROVIDER COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	eCrCl to be calculated from serum creatinine using the Cockcroft-Gault formula.
			Nursing Orders
  	ONC NURSING COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Abbreviated exam before dosing on D1 of every cycle must be performed by a physician or a qualified delegate. Must include and at minimum: 
o General appearance; 
o Skin (paleness, jaundice, redness/rash, acneiform changes); 
o Ears, eyes (jaundice, inflammation) nose, throat (presence of petechial bleedings, gingival bleeding); 
o Lungs; 
o Heart;  
o Abdomen (pain, tenderness, peristaltic, ascites, organomegaly); 
o Lymph nodes;  
o Extremities (petechial bleedings, ulcers, signs of thrombosis), hands and feet (signs of hand-foot syndrome/palmar-plantar erythrodysesthesia).
		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Abbreviated neurological examination to include the following assessments: 
o Section 1.14 Oculomotor testing, pupil accommodation, double images;  
o Section 1.15 Motor system: muscle strength of arms; 
o Section 1.16 Sensory system: pain and touch sensation of thighs; 
o Section 1.17 Mental Status (awareness of self and environment);  
o Section 1.18 Posture; 
o Section 1.19 Coordination: finger-to-nose and heel-to-shin test.
		  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	Other aspects/body parts or organ systems may be assessed at the Investigator's discretion.
		  	MEASURE WEIGHT	Interval: --	Occurrences: --	Comments:	Body weight measured before the start of treatment on C1D1 will be used to calculate the MT-6402 dose in all subsequent cycles. The dose must be recalculated when the body weight has changed by GREATER than or EQUAL to 10% from the baseline value; or according to institutional policies. Once a subject's weight changes by GREATER than or EQUAL to 10% and a new dose is administered, this weight is considered the new baseline. For subsequent cycles, this weight will be considered the new baseline to assess for changes in weight.
		  	ONC NURSING COMMUNICATION 8	Interval: --	Occurrences: --	Comments:	New York Heart Association: The classification of cardiac function will be performed for subjects with heart failure according to the NYHA (Section 10.6). Only applicable to subjects with heart failure.
		  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	ECOG
		  	ONC NURSING COMMUNICATION 10	Interval: --	Occurrences: --	Comments:	Adverse Event Review
		  	ONC NURSING COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	Concomitant Medication Review
			Nursing Orders
  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	o Triplicate 12-lead ECG. 
o Predose (LESS than or EQUAL to 4 hr prior to start of infusion); 
o 5 mins (+/- 5mins) after end of infusion; 
o 2 hrs (+/- 10mins) after end of infusion; 
o 4 hrs (+/- 10mins) after end of infusion.
			Nursing Orders
  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	o Measured after at least 5 mins of quiet rest in a sitting or semi-recumbant position
o Must include: BP (systolic and diastolic), respiratory rate, heart rate, body temperature
o When possible use the same body position and method of measurement of vital signs throughout a subject's participation in the study.
o All Cycles D8, D15, D22: 
a. Pre-dose (any time prior to start of infusion); 
b. 0.5, 1, 2 hours after start of infusion.
			Labs
  	URINALYSIS, AUTOMATED WITH MICROSCOPY	Interval: --	Occurrences: --			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --			Labs
  	AMYLASE LEVEL	Interval: --	Occurrences: --		  	LIPASE LEVEL	Interval: --	Occurrences: --			Labs
  	BILIRUBIN DIRECT	Interval: --	Occurrences: --			Labs
  	PHOSPHORUS LEVEL	Interval: --	Occurrences: --			Labs
  	URIC ACID LEVEL	Interval: --	Occurrences: --			Labs
  	LDH	Interval: --	Occurrences: --			Labs
  	CREATINE KINASE, TOTAL (CPK)	Interval: --	Occurrences: --	Comments:	Including isoenzymes, is > ULN
		  	C-REACTIVE PROTEIN	Interval: --	Occurrences: --		  	GGT	Interval: --	Occurrences: --			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mEq/L; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Treatment Conditions
  	TREATMENT CONDITIONS	Interval: --	Occurrences: --	Comments:	In the event of an unexplained clinically significant abnormal laboratory test value, the test should be repeated immediately and followed up until it has returned to the normal range and/or an adequate explanation of the abnormality is found. 
Laboratory test results will be graded according to the CTCAE v. 5.0 criteria. In general, a confirmed Grade 3 or Grade 4 abnormal laboratory test result is considered to be an AE and needs to be reported in the eCRF if at least 1 of the below criteria is met: 
1) The abnormality suggests a disease (except the disease under study) and/or organ toxicity; 
2) The abnormality is of a degree that requires active management; eg, change of dose, discontinuation of the drug, more frequent follow-up assessments, further diagnostic investigation, initiation of concomitant medication, etc. 
Confirmed Grade 2 abnormal laboratory results will be assessed on a case-by-case basis for clinical significance based upon the subject's baseline value screening, the duration of the abnormal result, the need for and type of treatment and/or further evaluation required. Abnormal laboratory test results meeting SAE criteria will be reported as such.
			Pre-Medications
  	ondansetron (ZOFRAN) 16 mg, dexAMETHasone (DECADRON) 12 mg in sodium chloride 0.9% 50 mL IVPB	Dose: 16 mg	Route: intravenous	once over 10 Minutes for 1 dose	Start: S			Ingredients:	Name	Type	Dose	Selected	Adds Vol.	ONDANSETRON HCL 2 MG/ML INTRAVENOUS SOLUTION	Medications	16 mg	Main Ingredient	No	DEXAMETHASONE SODIUM PHOSPHATE 10 MG/ML INJECTION SOLUTION	Medications	12 mg	Yes	No	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	Base	50 mL	Yes	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	Base	50 mL	No	Yes			  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	once for 1 dose	Start: S					Chemotherapy
  	ONC PROVIDER COMMUNICATION 3	Interval: --	Occurrences: --	Comments:	This schedule may be modified to Days 1, 8, and 15 or to Days 1 and 15 based on tolerability. MT-6402 doses may be administered within a 2-day window if deemed appropriate by the Investigator (protocol page 62). In Part B for subjects with clinical benefit (confirmed complete response [CR], partial response [PR] for at least 12 weeks, or stable disease [SD] for at least 24 weeks) and after agreement between the treating Investigator and the Medical Monitor, the treatment can be suspended for up to 8 weeks and later resumed if in the Investigator's opinion it is in the subject's best interest. The subject needs to attend the scheduled imaging assessment during the drug holiday.
		  	INV-MT-6402 IV (MT-6402-001/PRO00037462/ZHANG) ORDERABLE 16 mcg/kg (Treatment Plan)	Dose: 16 mcg/kg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer intravenously over 30 minutes (+/-5 minutes) using 0.2 micron inline filter for syringe and IV bag. Flush the line with NS so that the entire MT-6402 solution is administered to the patient.  Final concentration must be between 30-100mcg/mL. Prepared solution for infusion must be administered as soon as possible and within the same day. 
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.

			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only – itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Fexofenadine 180 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 – MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms – shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Fexofenadine 180 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	fexofenadine (ALLEGRA) tablet 180 mg	Dose: 180 mg	Route: oral	PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled				Day 22	Perform every 1 day x1		Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Line Flush
  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Nursing Orders
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Provider Communication
  	ONC PROVIDER COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	eCrCl to be calculated from serum creatinine using the Cockcroft-Gault formula.
			Provider Communication
  	ONC PROVIDER COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Tumor Tissue Biopsy (central lab) All subjects must submit a fresh tumor biopsy to the central lab for biomarker analysis within 2 weeks of completion of Cycle 2
			Nursing Orders
  	ONC NURSING COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Abbreviated exam before dosing on D1 of every cycle must be performed by a physician or a qualified delegate. Must include and at minimum: 
o General appearance; 
o Skin (paleness, jaundice, redness/rash, acneiform changes); 
o Ears, eyes (jaundice, inflammation) nose, throat (presence of petechial bleedings, gingival bleeding); 
o Lungs; 
o Heart;  
o Abdomen (pain, tenderness, peristaltic, ascites, organomegaly); 
o Lymph nodes;  
o Extremities (petechial bleedings, ulcers, signs of thrombosis), hands and feet (signs of hand-foot syndrome/palmar-plantar erythrodysesthesia).
		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Abbreviated neurological examination to include the following assessments: 
o Section 1.14 Oculomotor testing, pupil accommodation, double images;  
o Section 1.15 Motor system: muscle strength of arms; 
o Section 1.16 Sensory system: pain and touch sensation of thighs; 
o Section 1.17 Mental Status (awareness of self and environment);  
o Section 1.18 Posture; 
o Section 1.19 Coordination: finger-to-nose and heel-to-shin test.
		  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	Other aspects/body parts or organ systems may be assessed at the Investigator's discretion.
		  	MEASURE WEIGHT	Interval: --	Occurrences: --	Comments:	Body weight measured before the start of treatment on C1D1 will be used to calculate the MT-6402 dose in all subsequent cycles. The dose must be recalculated when the body weight has changed by GREATER than or EQUAL to 10% from the baseline value; or according to institutional policies. Once a subject's weight changes by GREATER than or EQUAL to 10% and a new dose is administered, this weight is considered the new baseline. For subsequent cycles, this weight will be considered the new baseline to assess for changes in weight.
		  	ONC NURSING COMMUNICATION 8	Interval: --	Occurrences: --	Comments:	New York Heart Association: The classification of cardiac function will be performed for subjects with heart failure according to the NYHA (Section 10.6). Only applicable to subjects with heart failure.
		  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	ECOG
		  	ONC NURSING COMMUNICATION 10	Interval: --	Occurrences: --	Comments:	Adverse Event Review
		  	ONC NURSING COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	Concomitant Medication Review
			Nursing Orders
  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	o Triplicate 12-lead ECG. 
o Predose (LESS than or EQUAL to 4 hr prior to start of infusion); 
o 5 mins (+/- 5mins) after end of infusion; 
o 2 hrs (+/- 10mins) after end of infusion; 
o 4 hrs (+/- 10mins) after end of infusion.
			Nursing Orders
  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	o Measured after at least 5 mins of quiet rest in a sitting or semi-recumbant position
o Must include: BP (systolic and diastolic), respiratory rate, heart rate, body temperature
o When possible use the same body position and method of measurement of vital signs throughout a subject's participation in the study.
o All Cycles D8, D15, D22: 
a. Pre-dose (any time prior to start of infusion); 
b. 0.5, 1, 2 hours after start of infusion.
			Labs
  	URINALYSIS, AUTOMATED WITH MICROSCOPY	Interval: --	Occurrences: --			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --			Labs
  	AMYLASE LEVEL	Interval: --	Occurrences: --		  	LIPASE LEVEL	Interval: --	Occurrences: --			Labs
  	BILIRUBIN DIRECT	Interval: --	Occurrences: --			Labs
  	PHOSPHORUS LEVEL	Interval: --	Occurrences: --			Labs
  	URIC ACID LEVEL	Interval: --	Occurrences: --			Labs
  	LDH	Interval: --	Occurrences: --			Labs
  	CREATINE KINASE, TOTAL (CPK)	Interval: --	Occurrences: --	Comments:	Including isoenzymes, is > ULN
		  	GGT	Interval: --	Occurrences: --			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mEq/L; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Treatment Conditions
  	TREATMENT CONDITIONS	Interval: --	Occurrences: --	Comments:	In the event of an unexplained clinically significant abnormal laboratory test value, the test should be repeated immediately and followed up until it has returned to the normal range and/or an adequate explanation of the abnormality is found. 
Laboratory test results will be graded according to the CTCAE v. 5.0 criteria. In general, a confirmed Grade 3 or Grade 4 abnormal laboratory test result is considered to be an AE and needs to be reported in the eCRF if at least 1 of the below criteria is met: 
1) The abnormality suggests a disease (except the disease under study) and/or organ toxicity; 
2) The abnormality is of a degree that requires active management; eg, change of dose, discontinuation of the drug, more frequent follow-up assessments, further diagnostic investigation, initiation of concomitant medication, etc. 
Confirmed Grade 2 abnormal laboratory results will be assessed on a case-by-case basis for clinical significance based upon the subject's baseline value screening, the duration of the abnormal result, the need for and type of treatment and/or further evaluation required. Abnormal laboratory test results meeting SAE criteria will be reported as such.
			Pre-Medications
  	ondansetron (ZOFRAN) 16 mg, dexAMETHasone (DECADRON) 12 mg in sodium chloride 0.9% 50 mL IVPB	Dose: 16 mg	Route: intravenous	once over 10 Minutes for 1 dose	Start: S			Ingredients:	Name	Type	Dose	Selected	Adds Vol.	ONDANSETRON HCL 2 MG/ML INTRAVENOUS SOLUTION	Medications	16 mg	Main Ingredient	No	DEXAMETHASONE SODIUM PHOSPHATE 10 MG/ML INJECTION SOLUTION	Medications	12 mg	Yes	No	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	Base	50 mL	Yes	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	Base	50 mL	No	Yes			  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	once for 1 dose	Start: S					Chemotherapy
  	ONC PROVIDER COMMUNICATION 3	Interval: --	Occurrences: --	Comments:	This schedule may be modified to Days 1, 8, and 15 or to Days 1 and 15 based on tolerability. MT-6402 doses may be administered within a 2-day window if deemed appropriate by the Investigator (protocol page 62). In Part B for subjects with clinical benefit (confirmed complete response [CR], partial response [PR] for at least 12 weeks, or stable disease [SD] for at least 24 weeks) and after agreement between the treating Investigator and the Medical Monitor, the treatment can be suspended for up to 8 weeks and later resumed if in the Investigator's opinion it is in the subject's best interest. The subject needs to attend the scheduled imaging assessment during the drug holiday.
		  	INV-MT-6402 IV (MT-6402-001/PRO00037462/ZHANG) ORDERABLE 16 mcg/kg (Treatment Plan)	Dose: 16 mcg/kg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer intravenously over 30 minutes (+/-5 minutes) using 0.2 micron inline filter for syringe and IV bag. Flush the line with NS so that the entire MT-6402 solution is administered to the patient.  Final concentration must be between 30-100mcg/mL. Prepared solution for infusion must be administered as soon as possible and within the same day. 
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.

			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only – itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Fexofenadine 180 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 – MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms – shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Fexofenadine 180 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	fexofenadine (ALLEGRA) tablet 180 mg	Dose: 180 mg	Route: oral	PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled					
Cycle 3	Repeat 1 time	Cycle length: 28 days	Day 1	Perform every 1 day x1		Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Line Flush
  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Nursing Orders
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Provider Communication
  	ONC PROVIDER COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	eCrCl to be calculated from serum creatinine using the Cockcroft-Gault formula.
			Nursing Orders
  	ONC NURSING COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Abbreviated exam before dosing on D1 of every cycle must be performed by a physician or a qualified delegate. Must include and at minimum: 
o General appearance; 
o Skin (paleness, jaundice, redness/rash, acneiform changes); 
o Ears, eyes (jaundice, inflammation) nose, throat (presence of petechial bleedings, gingival bleeding); 
o Lungs; 
o Heart;  
o Abdomen (pain, tenderness, peristaltic, ascites, organomegaly); 
o Lymph nodes;  
o Extremities (petechial bleedings, ulcers, signs of thrombosis), hands and feet (signs of hand-foot syndrome/palmar-plantar erythrodysesthesia).
		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Abbreviated neurological examination to include the following assessments: 
o Section 1.14 Oculomotor testing, pupil accommodation, double images;  
o Section 1.15 Motor system: muscle strength of arms; 
o Section 1.16 Sensory system: pain and touch sensation of thighs; 
o Section 1.17 Mental Status (awareness of self and environment);  
o Section 1.18 Posture; 
o Section 1.19 Coordination: finger-to-nose and heel-to-shin test.
		  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	Other aspects/body parts or organ systems may be assessed at the Investigator's discretion.
		  	MEASURE WEIGHT	Interval: --	Occurrences: --	Comments:	Body weight measured before the start of treatment on C1D1 will be used to calculate the MT-6402 dose in all subsequent cycles. The dose must be recalculated when the body weight has changed by GREATER than or EQUAL to 10% from the baseline value; or according to institutional policies. Once a subject's weight changes by GREATER than or EQUAL to 10% and a new dose is administered, this weight is considered the new baseline. For subsequent cycles, this weight will be considered the new baseline to assess for changes in weight.
		  	ONC NURSING COMMUNICATION 8	Interval: --	Occurrences: --	Comments:	New York Heart Association: The classification of cardiac function will be performed for subjects with heart failure according to the NYHA (Section 10.6). Only applicable to subjects with heart failure.
		  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	ECOG
		  	ONC NURSING COMMUNICATION 10	Interval: --	Occurrences: --	Comments:	Adverse Event Review
		  	ONC NURSING COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	Concomitant Medication Review
			Nursing Orders
  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	o Measured after at least 5 mins of quiet rest in a sitting or semi-recumbant position
o Must include: BP (systolic and diastolic), respiratory rate, heart rate, body temperature
o When possible use the same body position and method of measurement of vital signs throughout a subject's participation in the study.
o C2D1: 
a. Pre-dose (any time prior to start of infusion); 
b. 0.5, 1, 2 hours after start of infusion.
			Nursing Orders
  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	o Predose (</= 4 hr prior to start of infusion); 
o 5 mins (+/- 5mins) after end of infusion; 
o 2 hrs (+/- 10mins) after end of infusion.
			Imaging
  	TRANSTHORACIC ECHOCARDIOGRAM STRESS W DOP W CONT IF NEEDED	Interval: --	Occurrences: --	Comments:	o A pre-study LVEF assessment is acceptable if obtained within 28 days before starting study treatment. 
o Preferably full 3D ECHO or if not available, MUGA. The LVEF should be reported based on Simpson's biplane method. Results should be reported as a single value rather than a range. 
o During study: collected within 2 weeks before D1 dosing of every odd cycle (C3, C5, C7, etc).
			Labs
  	URINALYSIS, AUTOMATED WITH MICROSCOPY	Interval: --	Occurrences: --			Labs
  	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	Serum HCG 
Only applicable for WOCBP. Subjects who are postmenopausal (GREATER than 1 year since last menstrual cycle) or permanently sterilized (ie: bilateral tubal occlusion, hysterectomy,  bilateral salpingectomy) may be considered as not of reproductive potential. 
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --			Labs
  	AMYLASE LEVEL	Interval: --	Occurrences: --		  	LIPASE LEVEL	Interval: --	Occurrences: --			Labs
  	BILIRUBIN DIRECT	Interval: --	Occurrences: --			Labs
  	PHOSPHORUS LEVEL	Interval: --	Occurrences: --			Labs
  	URIC ACID LEVEL	Interval: --	Occurrences: --			Labs
  	LDH	Interval: --	Occurrences: --			Labs
  	HEMOGLOBIN A1C	Interval: --	Occurrences: --			Labs
  	CREATINE KINASE, TOTAL (CPK)	Interval: --	Occurrences: --	Comments:	Including isoenzymes, is > ULN
		  	C-REACTIVE PROTEIN	Interval: --	Occurrences: --		  	GGT	Interval: --	Occurrences: --		  	CORTISOL LEVEL, RANDOM	Interval: --	Occurrences: --		  	TSH AND FREE T4	Interval: --	Occurrences: --			Labs
  	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --		  	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Samples for PK must be drawn from a different line than that used for MT-6402 administration.
o Predose (</= 4 hr prior to start of infusion); 
o 5 mins (+/- 1min) after end of infusion; 
o 2 hr (+/- 10 mins) after end of infusion.
			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mEq/L; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Treatment Conditions
  	TREATMENT CONDITIONS	Interval: --	Occurrences: --	Comments:	In the event of an unexplained clinically significant abnormal laboratory test value, the test should be repeated immediately and followed up until it has returned to the normal range and/or an adequate explanation of the abnormality is found. 
Laboratory test results will be graded according to the CTCAE v. 5.0 criteria. In general, a confirmed Grade 3 or Grade 4 abnormal laboratory test result is considered to be an AE and needs to be reported in the eCRF if at least 1 of the below criteria is met: 
1) The abnormality suggests a disease (except the disease under study) and/or organ toxicity; 
2) The abnormality is of a degree that requires active management; eg, change of dose, discontinuation of the drug, more frequent follow-up assessments, further diagnostic investigation, initiation of concomitant medication, etc. 
Confirmed Grade 2 abnormal laboratory results will be assessed on a case-by-case basis for clinical significance based upon the subject's baseline value screening, the duration of the abnormal result, the need for and type of treatment and/or further evaluation required. Abnormal laboratory test results meeting SAE criteria will be reported as such.
			Pre-Medications
  	ondansetron (ZOFRAN) 16 mg, dexAMETHasone (DECADRON) 12 mg in sodium chloride 0.9% 50 mL IVPB	Dose: 16 mg	Route: intravenous	once over 10 Minutes for 1 dose	Start: S			Ingredients:	Name	Type	Dose	Selected	Adds Vol.	ONDANSETRON HCL 2 MG/ML INTRAVENOUS SOLUTION	Medications	16 mg	Main Ingredient	No	DEXAMETHASONE SODIUM PHOSPHATE 10 MG/ML INJECTION SOLUTION	Medications	12 mg	Yes	No	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	Base	50 mL	Yes	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	Base	50 mL	No	Yes			  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	once for 1 dose	Start: S					Chemotherapy
  	ONC PROVIDER COMMUNICATION 3	Interval: --	Occurrences: --	Comments:	This schedule may be modified to Days 1, 8, and 15 or to Days 1 and 15 based on tolerability. MT-6402 doses may be administered within a 2-day window if deemed appropriate by the Investigator (protocol page 62). In Part B for subjects with clinical benefit (confirmed complete response [CR], partial response [PR] for at least 12 weeks, or stable disease [SD] for at least 24 weeks) and after agreement between the treating Investigator and the Medical Monitor, the treatment can be suspended for up to 8 weeks and later resumed if in the Investigator's opinion it is in the subject's best interest. The subject needs to attend the scheduled imaging assessment during the drug holiday.
		  	INV-MT-6402 IV (MT-6402-001/PRO00037462/ZHANG) ORDERABLE 16 mcg/kg (Treatment Plan)	Dose: 16 mcg/kg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer intravenously over 30 minutes (+/-5 minutes) using 0.2 micron inline filter for syringe and IV bag. Flush the line with NS so that the entire MT-6402 solution is administered to the patient.  Final concentration must be between 30-100mcg/mL. Prepared solution for infusion must be administered as soon as possible and within the same day. 
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.

			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only – itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Fexofenadine 180 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 – MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms – shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Fexofenadine 180 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	fexofenadine (ALLEGRA) tablet 180 mg	Dose: 180 mg	Route: oral	PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled				Day 8	Perform every 1 day x1		Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Line Flush
  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Nursing Orders
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Provider Communication
  	ONC PROVIDER COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	eCrCl to be calculated from serum creatinine using the Cockcroft-Gault formula.
			Nursing Orders
  	ONC NURSING COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Abbreviated exam before dosing on D1 of every cycle must be performed by a physician or a qualified delegate. Must include and at minimum: 
o General appearance; 
o Skin (paleness, jaundice, redness/rash, acneiform changes); 
o Ears, eyes (jaundice, inflammation) nose, throat (presence of petechial bleedings, gingival bleeding); 
o Lungs; 
o Heart;  
o Abdomen (pain, tenderness, peristaltic, ascites, organomegaly); 
o Lymph nodes;  
o Extremities (petechial bleedings, ulcers, signs of thrombosis), hands and feet (signs of hand-foot syndrome/palmar-plantar erythrodysesthesia).
		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Abbreviated neurological examination to include the following assessments: 
o Section 1.14 Oculomotor testing, pupil accommodation, double images;  
o Section 1.15 Motor system: muscle strength of arms; 
o Section 1.16 Sensory system: pain and touch sensation of thighs; 
o Section 1.17 Mental Status (awareness of self and environment);  
o Section 1.18 Posture; 
o Section 1.19 Coordination: finger-to-nose and heel-to-shin test.
		  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	Other aspects/body parts or organ systems may be assessed at the Investigator's discretion.
		  	MEASURE WEIGHT	Interval: --	Occurrences: --	Comments:	Body weight measured before the start of treatment on C1D1 will be used to calculate the MT-6402 dose in all subsequent cycles. The dose must be recalculated when the body weight has changed by GREATER than or EQUAL to 10% from the baseline value; or according to institutional policies. Once a subject's weight changes by GREATER than or EQUAL to 10% and a new dose is administered, this weight is considered the new baseline. For subsequent cycles, this weight will be considered the new baseline to assess for changes in weight.
		  	ONC NURSING COMMUNICATION 8	Interval: --	Occurrences: --	Comments:	New York Heart Association: The classification of cardiac function will be performed for subjects with heart failure according to the NYHA (Section 10.6). Only applicable to subjects with heart failure.
		  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	ECOG
		  	ONC NURSING COMMUNICATION 10	Interval: --	Occurrences: --	Comments:	Adverse Event Review
		  	ONC NURSING COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	Concomitant Medication Review
			Nursing Orders
  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	o Measured after at least 5 mins of quiet rest in a sitting or semi-recumbant position
o Must include: BP (systolic and diastolic), respiratory rate, heart rate, body temperature
o When possible use the same body position and method of measurement of vital signs throughout a subject's participation in the study.
o All Cycles D8, D15, D22: 
a. Pre-dose (any time prior to start of infusion); 
b. 0.5, 1, 2 hours after start of infusion.
			Labs
  	URINALYSIS, AUTOMATED WITH MICROSCOPY	Interval: --	Occurrences: --			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --			Labs
  	AMYLASE LEVEL	Interval: --	Occurrences: --		  	LIPASE LEVEL	Interval: --	Occurrences: --			Labs
  	BILIRUBIN DIRECT	Interval: --	Occurrences: --			Labs
  	PHOSPHORUS LEVEL	Interval: --	Occurrences: --			Labs
  	URIC ACID LEVEL	Interval: --	Occurrences: --			Labs
  	LDH	Interval: --	Occurrences: --			Labs
  	CREATINE KINASE, TOTAL (CPK)	Interval: --	Occurrences: --	Comments:	Including isoenzymes, is > ULN
		  	GGT	Interval: --	Occurrences: --			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mEq/L; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Treatment Conditions
  	TREATMENT CONDITIONS	Interval: --	Occurrences: --	Comments:	In the event of an unexplained clinically significant abnormal laboratory test value, the test should be repeated immediately and followed up until it has returned to the normal range and/or an adequate explanation of the abnormality is found. 
Laboratory test results will be graded according to the CTCAE v. 5.0 criteria. In general, a confirmed Grade 3 or Grade 4 abnormal laboratory test result is considered to be an AE and needs to be reported in the eCRF if at least 1 of the below criteria is met: 
1) The abnormality suggests a disease (except the disease under study) and/or organ toxicity; 
2) The abnormality is of a degree that requires active management; eg, change of dose, discontinuation of the drug, more frequent follow-up assessments, further diagnostic investigation, initiation of concomitant medication, etc. 
Confirmed Grade 2 abnormal laboratory results will be assessed on a case-by-case basis for clinical significance based upon the subject's baseline value screening, the duration of the abnormal result, the need for and type of treatment and/or further evaluation required. Abnormal laboratory test results meeting SAE criteria will be reported as such.
			Pre-Medications
  	ondansetron (ZOFRAN) 16 mg, dexAMETHasone (DECADRON) 12 mg in sodium chloride 0.9% 50 mL IVPB	Dose: 16 mg	Route: intravenous	once over 10 Minutes for 1 dose	Start: S			Ingredients:	Name	Type	Dose	Selected	Adds Vol.	ONDANSETRON HCL 2 MG/ML INTRAVENOUS SOLUTION	Medications	16 mg	Main Ingredient	No	DEXAMETHASONE SODIUM PHOSPHATE 10 MG/ML INJECTION SOLUTION	Medications	12 mg	Yes	No	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	Base	50 mL	Yes	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	Base	50 mL	No	Yes			  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	once for 1 dose	Start: S					Chemotherapy
  	ONC PROVIDER COMMUNICATION 3	Interval: --	Occurrences: --	Comments:	This schedule may be modified to Days 1, 8, and 15 or to Days 1 and 15 based on tolerability. MT-6402 doses may be administered within a 2-day window if deemed appropriate by the Investigator (protocol page 62). In Part B for subjects with clinical benefit (confirmed complete response [CR], partial response [PR] for at least 12 weeks, or stable disease [SD] for at least 24 weeks) and after agreement between the treating Investigator and the Medical Monitor, the treatment can be suspended for up to 8 weeks and later resumed if in the Investigator's opinion it is in the subject's best interest. The subject needs to attend the scheduled imaging assessment during the drug holiday.
		  	INV-MT-6402 IV (MT-6402-001/PRO00037462/ZHANG) ORDERABLE 16 mcg/kg (Treatment Plan)	Dose: 16 mcg/kg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer intravenously over 30 minutes (+/-5 minutes) using 0.2 micron inline filter for syringe and IV bag. Flush the line with NS so that the entire MT-6402 solution is administered to the patient.  Final concentration must be between 30-100mcg/mL. Prepared solution for infusion must be administered as soon as possible and within the same day. 
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.

			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only – itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Fexofenadine 180 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 – MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms – shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Fexofenadine 180 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	fexofenadine (ALLEGRA) tablet 180 mg	Dose: 180 mg	Route: oral	PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled				Day 15	Perform every 1 day x1		Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Line Flush
  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Nursing Orders
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Provider Communication
  	ONC PROVIDER COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	eCrCl to be calculated from serum creatinine using the Cockcroft-Gault formula.
			Nursing Orders
  	ONC NURSING COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Abbreviated exam before dosing on D1 of every cycle must be performed by a physician or a qualified delegate. Must include and at minimum: 
o General appearance; 
o Skin (paleness, jaundice, redness/rash, acneiform changes); 
o Ears, eyes (jaundice, inflammation) nose, throat (presence of petechial bleedings, gingival bleeding); 
o Lungs; 
o Heart;  
o Abdomen (pain, tenderness, peristaltic, ascites, organomegaly); 
o Lymph nodes;  
o Extremities (petechial bleedings, ulcers, signs of thrombosis), hands and feet (signs of hand-foot syndrome/palmar-plantar erythrodysesthesia).
		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Abbreviated neurological examination to include the following assessments: 
o Section 1.14 Oculomotor testing, pupil accommodation, double images;  
o Section 1.15 Motor system: muscle strength of arms; 
o Section 1.16 Sensory system: pain and touch sensation of thighs; 
o Section 1.17 Mental Status (awareness of self and environment);  
o Section 1.18 Posture; 
o Section 1.19 Coordination: finger-to-nose and heel-to-shin test.
		  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	Other aspects/body parts or organ systems may be assessed at the Investigator's discretion.
		  	MEASURE WEIGHT	Interval: --	Occurrences: --	Comments:	Body weight measured before the start of treatment on C1D1 will be used to calculate the MT-6402 dose in all subsequent cycles. The dose must be recalculated when the body weight has changed by GREATER than or EQUAL to 10% from the baseline value; or according to institutional policies. Once a subject's weight changes by GREATER than or EQUAL to 10% and a new dose is administered, this weight is considered the new baseline. For subsequent cycles, this weight will be considered the new baseline to assess for changes in weight.
		  	ONC NURSING COMMUNICATION 8	Interval: --	Occurrences: --	Comments:	New York Heart Association: The classification of cardiac function will be performed for subjects with heart failure according to the NYHA (Section 10.6). Only applicable to subjects with heart failure.
		  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	ECOG
		  	ONC NURSING COMMUNICATION 10	Interval: --	Occurrences: --	Comments:	Adverse Event Review
		  	ONC NURSING COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	Concomitant Medication Review
			Nursing Orders
  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	o Measured after at least 5 mins of quiet rest in a sitting or semi-recumbant position
o Must include: BP (systolic and diastolic), respiratory rate, heart rate, body temperature
o When possible use the same body position and method of measurement of vital signs throughout a subject's participation in the study.
o All Cycles D8, D15, D22: 
a. Pre-dose (any time prior to start of infusion); 
b. 0.5, 1, 2 hours after start of infusion.
			Labs
  	URINALYSIS, AUTOMATED WITH MICROSCOPY	Interval: --	Occurrences: --			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --			Labs
  	AMYLASE LEVEL	Interval: --	Occurrences: --		  	LIPASE LEVEL	Interval: --	Occurrences: --			Labs
  	BILIRUBIN DIRECT	Interval: --	Occurrences: --			Labs
  	PHOSPHORUS LEVEL	Interval: --	Occurrences: --			Labs
  	URIC ACID LEVEL	Interval: --	Occurrences: --			Labs
  	LDH	Interval: --	Occurrences: --			Labs
  	CREATINE KINASE, TOTAL (CPK)	Interval: --	Occurrences: --	Comments:	Including isoenzymes, is > ULN
		  	C-REACTIVE PROTEIN	Interval: --	Occurrences: --		  	GGT	Interval: --	Occurrences: --			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mEq/L; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Treatment Conditions
  	TREATMENT CONDITIONS	Interval: --	Occurrences: --	Comments:	In the event of an unexplained clinically significant abnormal laboratory test value, the test should be repeated immediately and followed up until it has returned to the normal range and/or an adequate explanation of the abnormality is found. 
Laboratory test results will be graded according to the CTCAE v. 5.0 criteria. In general, a confirmed Grade 3 or Grade 4 abnormal laboratory test result is considered to be an AE and needs to be reported in the eCRF if at least 1 of the below criteria is met: 
1) The abnormality suggests a disease (except the disease under study) and/or organ toxicity; 
2) The abnormality is of a degree that requires active management; eg, change of dose, discontinuation of the drug, more frequent follow-up assessments, further diagnostic investigation, initiation of concomitant medication, etc. 
Confirmed Grade 2 abnormal laboratory results will be assessed on a case-by-case basis for clinical significance based upon the subject's baseline value screening, the duration of the abnormal result, the need for and type of treatment and/or further evaluation required. Abnormal laboratory test results meeting SAE criteria will be reported as such.
			Pre-Medications
  	ondansetron (ZOFRAN) 16 mg, dexAMETHasone (DECADRON) 12 mg in sodium chloride 0.9% 50 mL IVPB	Dose: 16 mg	Route: intravenous	once over 10 Minutes for 1 dose	Start: S			Ingredients:	Name	Type	Dose	Selected	Adds Vol.	ONDANSETRON HCL 2 MG/ML INTRAVENOUS SOLUTION	Medications	16 mg	Main Ingredient	No	DEXAMETHASONE SODIUM PHOSPHATE 10 MG/ML INJECTION SOLUTION	Medications	12 mg	Yes	No	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	Base	50 mL	Yes	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	Base	50 mL	No	Yes			  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	once for 1 dose	Start: S					Chemotherapy
  	ONC PROVIDER COMMUNICATION 3	Interval: --	Occurrences: --	Comments:	This schedule may be modified to Days 1, 8, and 15 or to Days 1 and 15 based on tolerability. MT-6402 doses may be administered within a 2-day window if deemed appropriate by the Investigator (protocol page 62). In Part B for subjects with clinical benefit (confirmed complete response [CR], partial response [PR] for at least 12 weeks, or stable disease [SD] for at least 24 weeks) and after agreement between the treating Investigator and the Medical Monitor, the treatment can be suspended for up to 8 weeks and later resumed if in the Investigator's opinion it is in the subject's best interest. The subject needs to attend the scheduled imaging assessment during the drug holiday.
		  	INV-MT-6402 IV (MT-6402-001/PRO00037462/ZHANG) ORDERABLE 16 mcg/kg (Treatment Plan)	Dose: 16 mcg/kg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer intravenously over 30 minutes (+/-5 minutes) using 0.2 micron inline filter for syringe and IV bag. Flush the line with NS so that the entire MT-6402 solution is administered to the patient.  Final concentration must be between 30-100mcg/mL. Prepared solution for infusion must be administered as soon as possible and within the same day. 
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.

			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only – itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Fexofenadine 180 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 – MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms – shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Fexofenadine 180 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	fexofenadine (ALLEGRA) tablet 180 mg	Dose: 180 mg	Route: oral	PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled				Day 22	Perform every 1 day x1		Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Line Flush
  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Nursing Orders
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Provider Communication
  	ONC PROVIDER COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	eCrCl to be calculated from serum creatinine using the Cockcroft-Gault formula.
			Nursing Orders
  	ONC NURSING COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Abbreviated exam before dosing on D1 of every cycle must be performed by a physician or a qualified delegate. Must include and at minimum: 
o General appearance; 
o Skin (paleness, jaundice, redness/rash, acneiform changes); 
o Ears, eyes (jaundice, inflammation) nose, throat (presence of petechial bleedings, gingival bleeding); 
o Lungs; 
o Heart;  
o Abdomen (pain, tenderness, peristaltic, ascites, organomegaly); 
o Lymph nodes;  
o Extremities (petechial bleedings, ulcers, signs of thrombosis), hands and feet (signs of hand-foot syndrome/palmar-plantar erythrodysesthesia).
		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Abbreviated neurological examination to include the following assessments: 
o Section 1.14 Oculomotor testing, pupil accommodation, double images;  
o Section 1.15 Motor system: muscle strength of arms; 
o Section 1.16 Sensory system: pain and touch sensation of thighs; 
o Section 1.17 Mental Status (awareness of self and environment);  
o Section 1.18 Posture; 
o Section 1.19 Coordination: finger-to-nose and heel-to-shin test.
		  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	Other aspects/body parts or organ systems may be assessed at the Investigator's discretion.
		  	MEASURE WEIGHT	Interval: --	Occurrences: --	Comments:	Body weight measured before the start of treatment on C1D1 will be used to calculate the MT-6402 dose in all subsequent cycles. The dose must be recalculated when the body weight has changed by GREATER than or EQUAL to 10% from the baseline value; or according to institutional policies. Once a subject's weight changes by GREATER than or EQUAL to 10% and a new dose is administered, this weight is considered the new baseline. For subsequent cycles, this weight will be considered the new baseline to assess for changes in weight.
		  	ONC NURSING COMMUNICATION 8	Interval: --	Occurrences: --	Comments:	New York Heart Association: The classification of cardiac function will be performed for subjects with heart failure according to the NYHA (Section 10.6). Only applicable to subjects with heart failure.
		  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	ECOG
		  	ONC NURSING COMMUNICATION 10	Interval: --	Occurrences: --	Comments:	Adverse Event Review
		  	ONC NURSING COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	Concomitant Medication Review
			Nursing Orders
  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	o Measured after at least 5 mins of quiet rest in a sitting or semi-recumbant position
o Must include: BP (systolic and diastolic), respiratory rate, heart rate, body temperature
o When possible use the same body position and method of measurement of vital signs throughout a subject's participation in the study.
o All Cycles D8, D15, D22: 
a. Pre-dose (any time prior to start of infusion); 
b. 0.5, 1, 2 hours after start of infusion.
			Labs
  	URINALYSIS, AUTOMATED WITH MICROSCOPY	Interval: --	Occurrences: --			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --			Labs
  	AMYLASE LEVEL	Interval: --	Occurrences: --		  	LIPASE LEVEL	Interval: --	Occurrences: --			Labs
  	BILIRUBIN DIRECT	Interval: --	Occurrences: --			Labs
  	PHOSPHORUS LEVEL	Interval: --	Occurrences: --			Labs
  	URIC ACID LEVEL	Interval: --	Occurrences: --			Labs
  	LDH	Interval: --	Occurrences: --			Labs
  	CREATINE KINASE, TOTAL (CPK)	Interval: --	Occurrences: --	Comments:	Including isoenzymes, is > ULN
		  	GGT	Interval: --	Occurrences: --			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mEq/L; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Treatment Conditions
  	TREATMENT CONDITIONS	Interval: --	Occurrences: --	Comments:	In the event of an unexplained clinically significant abnormal laboratory test value, the test should be repeated immediately and followed up until it has returned to the normal range and/or an adequate explanation of the abnormality is found. 
Laboratory test results will be graded according to the CTCAE v. 5.0 criteria. In general, a confirmed Grade 3 or Grade 4 abnormal laboratory test result is considered to be an AE and needs to be reported in the eCRF if at least 1 of the below criteria is met: 
1) The abnormality suggests a disease (except the disease under study) and/or organ toxicity; 
2) The abnormality is of a degree that requires active management; eg, change of dose, discontinuation of the drug, more frequent follow-up assessments, further diagnostic investigation, initiation of concomitant medication, etc. 
Confirmed Grade 2 abnormal laboratory results will be assessed on a case-by-case basis for clinical significance based upon the subject's baseline value screening, the duration of the abnormal result, the need for and type of treatment and/or further evaluation required. Abnormal laboratory test results meeting SAE criteria will be reported as such.
			Pre-Medications
  	ondansetron (ZOFRAN) 16 mg, dexAMETHasone (DECADRON) 12 mg in sodium chloride 0.9% 50 mL IVPB	Dose: 16 mg	Route: intravenous	once over 10 Minutes for 1 dose	Start: S			Ingredients:	Name	Type	Dose	Selected	Adds Vol.	ONDANSETRON HCL 2 MG/ML INTRAVENOUS SOLUTION	Medications	16 mg	Main Ingredient	No	DEXAMETHASONE SODIUM PHOSPHATE 10 MG/ML INJECTION SOLUTION	Medications	12 mg	Yes	No	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	Base	50 mL	Yes	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	Base	50 mL	No	Yes			  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	once for 1 dose	Start: S					Chemotherapy
  	ONC PROVIDER COMMUNICATION 3	Interval: --	Occurrences: --	Comments:	This schedule may be modified to Days 1, 8, and 15 or to Days 1 and 15 based on tolerability. MT-6402 doses may be administered within a 2-day window if deemed appropriate by the Investigator (protocol page 62). In Part B for subjects with clinical benefit (confirmed complete response [CR], partial response [PR] for at least 12 weeks, or stable disease [SD] for at least 24 weeks) and after agreement between the treating Investigator and the Medical Monitor, the treatment can be suspended for up to 8 weeks and later resumed if in the Investigator's opinion it is in the subject's best interest. The subject needs to attend the scheduled imaging assessment during the drug holiday.
		  	INV-MT-6402 IV (MT-6402-001/PRO00037462/ZHANG) ORDERABLE 16 mcg/kg (Treatment Plan)	Dose: 16 mcg/kg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer intravenously over 30 minutes (+/-5 minutes) using 0.2 micron inline filter for syringe and IV bag. Flush the line with NS so that the entire MT-6402 solution is administered to the patient.  Final concentration must be between 30-100mcg/mL. Prepared solution for infusion must be administered as soon as possible and within the same day. 
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.

			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only – itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Fexofenadine 180 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 – MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms – shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Fexofenadine 180 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	fexofenadine (ALLEGRA) tablet 180 mg	Dose: 180 mg	Route: oral	PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled					
Cycle 4	Repeat 1 time	Cycle length: 28 days	Day 1	Perform every 1 day x1		Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Line Flush
  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Nursing Orders
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Provider Communication
  	ONC PROVIDER COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	eCrCl to be calculated from serum creatinine using the Cockcroft-Gault formula.
			Nursing Orders
  	ONC NURSING COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Abbreviated exam before dosing on D1 of every cycle must be performed by a physician or a qualified delegate. Must include and at minimum: 
o General appearance; 
o Skin (paleness, jaundice, redness/rash, acneiform changes); 
o Ears, eyes (jaundice, inflammation) nose, throat (presence of petechial bleedings, gingival bleeding); 
o Lungs; 
o Heart;  
o Abdomen (pain, tenderness, peristaltic, ascites, organomegaly); 
o Lymph nodes;  
o Extremities (petechial bleedings, ulcers, signs of thrombosis), hands and feet (signs of hand-foot syndrome/palmar-plantar erythrodysesthesia).
		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Abbreviated neurological examination to include the following assessments: 
o Section 1.14 Oculomotor testing, pupil accommodation, double images;  
o Section 1.15 Motor system: muscle strength of arms; 
o Section 1.16 Sensory system: pain and touch sensation of thighs; 
o Section 1.17 Mental Status (awareness of self and environment);  
o Section 1.18 Posture; 
o Section 1.19 Coordination: finger-to-nose and heel-to-shin test.
		  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	Other aspects/body parts or organ systems may be assessed at the Investigator's discretion.
		  	MEASURE WEIGHT	Interval: --	Occurrences: --	Comments:	Body weight measured before the start of treatment on C1D1 will be used to calculate the MT-6402 dose in all subsequent cycles. The dose must be recalculated when the body weight has changed by GREATER than or EQUAL to 10% from the baseline value; or according to institutional policies. Once a subject's weight changes by GREATER than or EQUAL to 10% and a new dose is administered, this weight is considered the new baseline. For subsequent cycles, this weight will be considered the new baseline to assess for changes in weight.
		  	ONC NURSING COMMUNICATION 8	Interval: --	Occurrences: --	Comments:	New York Heart Association: The classification of cardiac function will be performed for subjects with heart failure according to the NYHA (Section 10.6). Only applicable to subjects with heart failure.
		  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	ECOG
		  	ONC NURSING COMMUNICATION 10	Interval: --	Occurrences: --	Comments:	Adverse Event Review
		  	ONC NURSING COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	Concomitant Medication Review
			Nursing Orders
  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	o Measured after at least 5 mins of quiet rest in a sitting or semi-recumbant position
o Must include: BP (systolic and diastolic), respiratory rate, heart rate, body temperature
o When possible use the same body position and method of measurement of vital signs throughout a subject's participation in the study.
o C2D1: 
a. Pre-dose (any time prior to start of infusion); 
b. 0.5, 1, 2 hours after start of infusion.
			Nursing Orders
  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	o Predose (</= 4 hr prior to start of infusion); 
o 5 mins (+/- 5mins) after end of infusion; 
o 2 hrs (+/- 10mins) after end of infusion.
			Labs
  	URINALYSIS, AUTOMATED WITH MICROSCOPY	Interval: --	Occurrences: --			Labs
  	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	Serum HCG 
Only applicable for WOCBP. Subjects who are postmenopausal (GREATER than 1 year since last menstrual cycle) or permanently sterilized (ie: bilateral tubal occlusion, hysterectomy,  bilateral salpingectomy) may be considered as not of reproductive potential. 
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --			Labs
  	AMYLASE LEVEL	Interval: --	Occurrences: --		  	LIPASE LEVEL	Interval: --	Occurrences: --			Labs
  	BILIRUBIN DIRECT	Interval: --	Occurrences: --			Labs
  	PHOSPHORUS LEVEL	Interval: --	Occurrences: --			Labs
  	URIC ACID LEVEL	Interval: --	Occurrences: --			Labs
  	LDH	Interval: --	Occurrences: --			Labs
  	CREATINE KINASE, TOTAL (CPK)	Interval: --	Occurrences: --	Comments:	Including isoenzymes, is > ULN
		  	C-REACTIVE PROTEIN	Interval: --	Occurrences: --		  	GGT	Interval: --	Occurrences: --		  	CORTISOL LEVEL, RANDOM	Interval: --	Occurrences: --		  	TSH AND FREE T4	Interval: --	Occurrences: --			Labs
  	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --		  	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Samples for PK must be drawn from a different line than that used for MT-6402 administration.
o Predose (</= 4 hr prior to start of infusion); 
o 5 mins (+/- 1min) after end of infusion; 
o 2 hr (+/- 10 mins) after end of infusion.
			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mEq/L; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Treatment Conditions
  	TREATMENT CONDITIONS	Interval: --	Occurrences: --	Comments:	In the event of an unexplained clinically significant abnormal laboratory test value, the test should be repeated immediately and followed up until it has returned to the normal range and/or an adequate explanation of the abnormality is found. 
Laboratory test results will be graded according to the CTCAE v. 5.0 criteria. In general, a confirmed Grade 3 or Grade 4 abnormal laboratory test result is considered to be an AE and needs to be reported in the eCRF if at least 1 of the below criteria is met: 
1) The abnormality suggests a disease (except the disease under study) and/or organ toxicity; 
2) The abnormality is of a degree that requires active management; eg, change of dose, discontinuation of the drug, more frequent follow-up assessments, further diagnostic investigation, initiation of concomitant medication, etc. 
Confirmed Grade 2 abnormal laboratory results will be assessed on a case-by-case basis for clinical significance based upon the subject's baseline value screening, the duration of the abnormal result, the need for and type of treatment and/or further evaluation required. Abnormal laboratory test results meeting SAE criteria will be reported as such.
			Pre-Medications
  	ondansetron (ZOFRAN) 16 mg, dexAMETHasone (DECADRON) 12 mg in sodium chloride 0.9% 50 mL IVPB	Dose: 16 mg	Route: intravenous	once over 10 Minutes for 1 dose	Start: S			Ingredients:	Name	Type	Dose	Selected	Adds Vol.	ONDANSETRON HCL 2 MG/ML INTRAVENOUS SOLUTION	Medications	16 mg	Main Ingredient	No	DEXAMETHASONE SODIUM PHOSPHATE 10 MG/ML INJECTION SOLUTION	Medications	12 mg	Yes	No	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	Base	50 mL	Yes	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	Base	50 mL	No	Yes			  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	once for 1 dose	Start: S					Chemotherapy
  	ONC PROVIDER COMMUNICATION 3	Interval: --	Occurrences: --	Comments:	This schedule may be modified to Days 1, 8, and 15 or to Days 1 and 15 based on tolerability. MT-6402 doses may be administered within a 2-day window if deemed appropriate by the Investigator (protocol page 62). In Part B for subjects with clinical benefit (confirmed complete response [CR], partial response [PR] for at least 12 weeks, or stable disease [SD] for at least 24 weeks) and after agreement between the treating Investigator and the Medical Monitor, the treatment can be suspended for up to 8 weeks and later resumed if in the Investigator's opinion it is in the subject's best interest. The subject needs to attend the scheduled imaging assessment during the drug holiday.
		  	INV-MT-6402 IV (MT-6402-001/PRO00037462/ZHANG) ORDERABLE 16 mcg/kg (Treatment Plan)	Dose: 16 mcg/kg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer intravenously over 30 minutes (+/-5 minutes) using 0.2 micron inline filter for syringe and IV bag. Flush the line with NS so that the entire MT-6402 solution is administered to the patient.  Final concentration must be between 30-100mcg/mL. Prepared solution for infusion must be administered as soon as possible and within the same day. 
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.

			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only – itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Fexofenadine 180 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 – MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms – shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Fexofenadine 180 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	fexofenadine (ALLEGRA) tablet 180 mg	Dose: 180 mg	Route: oral	PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled				Day 8	Perform every 1 day x1		Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Line Flush
  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Nursing Orders
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Provider Communication
  	ONC PROVIDER COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	eCrCl to be calculated from serum creatinine using the Cockcroft-Gault formula.
			Nursing Orders
  	ONC NURSING COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Abbreviated exam before dosing on D1 of every cycle must be performed by a physician or a qualified delegate. Must include and at minimum: 
o General appearance; 
o Skin (paleness, jaundice, redness/rash, acneiform changes); 
o Ears, eyes (jaundice, inflammation) nose, throat (presence of petechial bleedings, gingival bleeding); 
o Lungs; 
o Heart;  
o Abdomen (pain, tenderness, peristaltic, ascites, organomegaly); 
o Lymph nodes;  
o Extremities (petechial bleedings, ulcers, signs of thrombosis), hands and feet (signs of hand-foot syndrome/palmar-plantar erythrodysesthesia).
		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Abbreviated neurological examination to include the following assessments: 
o Section 1.14 Oculomotor testing, pupil accommodation, double images;  
o Section 1.15 Motor system: muscle strength of arms; 
o Section 1.16 Sensory system: pain and touch sensation of thighs; 
o Section 1.17 Mental Status (awareness of self and environment);  
o Section 1.18 Posture; 
o Section 1.19 Coordination: finger-to-nose and heel-to-shin test.
		  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	Other aspects/body parts or organ systems may be assessed at the Investigator's discretion.
		  	MEASURE WEIGHT	Interval: --	Occurrences: --	Comments:	Body weight measured before the start of treatment on C1D1 will be used to calculate the MT-6402 dose in all subsequent cycles. The dose must be recalculated when the body weight has changed by GREATER than or EQUAL to 10% from the baseline value; or according to institutional policies. Once a subject's weight changes by GREATER than or EQUAL to 10% and a new dose is administered, this weight is considered the new baseline. For subsequent cycles, this weight will be considered the new baseline to assess for changes in weight.
		  	ONC NURSING COMMUNICATION 8	Interval: --	Occurrences: --	Comments:	New York Heart Association: The classification of cardiac function will be performed for subjects with heart failure according to the NYHA (Section 10.6). Only applicable to subjects with heart failure.
		  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	ECOG
		  	ONC NURSING COMMUNICATION 10	Interval: --	Occurrences: --	Comments:	Adverse Event Review
		  	ONC NURSING COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	Concomitant Medication Review
			Nursing Orders
  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	o Measured after at least 5 mins of quiet rest in a sitting or semi-recumbant position
o Must include: BP (systolic and diastolic), respiratory rate, heart rate, body temperature
o When possible use the same body position and method of measurement of vital signs throughout a subject's participation in the study.
o All Cycles D8, D15, D22: 
a. Pre-dose (any time prior to start of infusion); 
b. 0.5, 1, 2 hours after start of infusion.
			Labs
  	URINALYSIS, AUTOMATED WITH MICROSCOPY	Interval: --	Occurrences: --			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --			Labs
  	AMYLASE LEVEL	Interval: --	Occurrences: --		  	LIPASE LEVEL	Interval: --	Occurrences: --			Labs
  	BILIRUBIN DIRECT	Interval: --	Occurrences: --			Labs
  	PHOSPHORUS LEVEL	Interval: --	Occurrences: --			Labs
  	URIC ACID LEVEL	Interval: --	Occurrences: --			Labs
  	LDH	Interval: --	Occurrences: --			Labs
  	CREATINE KINASE, TOTAL (CPK)	Interval: --	Occurrences: --	Comments:	Including isoenzymes, is > ULN
		  	GGT	Interval: --	Occurrences: --			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mEq/L; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Treatment Conditions
  	TREATMENT CONDITIONS	Interval: --	Occurrences: --	Comments:	In the event of an unexplained clinically significant abnormal laboratory test value, the test should be repeated immediately and followed up until it has returned to the normal range and/or an adequate explanation of the abnormality is found. 
Laboratory test results will be graded according to the CTCAE v. 5.0 criteria. In general, a confirmed Grade 3 or Grade 4 abnormal laboratory test result is considered to be an AE and needs to be reported in the eCRF if at least 1 of the below criteria is met: 
1) The abnormality suggests a disease (except the disease under study) and/or organ toxicity; 
2) The abnormality is of a degree that requires active management; eg, change of dose, discontinuation of the drug, more frequent follow-up assessments, further diagnostic investigation, initiation of concomitant medication, etc. 
Confirmed Grade 2 abnormal laboratory results will be assessed on a case-by-case basis for clinical significance based upon the subject's baseline value screening, the duration of the abnormal result, the need for and type of treatment and/or further evaluation required. Abnormal laboratory test results meeting SAE criteria will be reported as such.
			Pre-Medications
  	ondansetron (ZOFRAN) 16 mg, dexAMETHasone (DECADRON) 12 mg in sodium chloride 0.9% 50 mL IVPB	Dose: 16 mg	Route: intravenous	once over 10 Minutes for 1 dose	Start: S			Ingredients:	Name	Type	Dose	Selected	Adds Vol.	ONDANSETRON HCL 2 MG/ML INTRAVENOUS SOLUTION	Medications	16 mg	Main Ingredient	No	DEXAMETHASONE SODIUM PHOSPHATE 10 MG/ML INJECTION SOLUTION	Medications	12 mg	Yes	No	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	Base	50 mL	Yes	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	Base	50 mL	No	Yes			  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	once for 1 dose	Start: S					Chemotherapy
  	ONC PROVIDER COMMUNICATION 3	Interval: --	Occurrences: --	Comments:	This schedule may be modified to Days 1, 8, and 15 or to Days 1 and 15 based on tolerability. MT-6402 doses may be administered within a 2-day window if deemed appropriate by the Investigator (protocol page 62). In Part B for subjects with clinical benefit (confirmed complete response [CR], partial response [PR] for at least 12 weeks, or stable disease [SD] for at least 24 weeks) and after agreement between the treating Investigator and the Medical Monitor, the treatment can be suspended for up to 8 weeks and later resumed if in the Investigator's opinion it is in the subject's best interest. The subject needs to attend the scheduled imaging assessment during the drug holiday.
		  	INV-MT-6402 IV (MT-6402-001/PRO00037462/ZHANG) ORDERABLE 16 mcg/kg (Treatment Plan)	Dose: 16 mcg/kg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer intravenously over 30 minutes (+/-5 minutes) using 0.2 micron inline filter for syringe and IV bag. Flush the line with NS so that the entire MT-6402 solution is administered to the patient.  Final concentration must be between 30-100mcg/mL. Prepared solution for infusion must be administered as soon as possible and within the same day. 
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.

			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only – itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Fexofenadine 180 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 – MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms – shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Fexofenadine 180 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	fexofenadine (ALLEGRA) tablet 180 mg	Dose: 180 mg	Route: oral	PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled				Day 15	Perform every 1 day x1		Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Line Flush
  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Nursing Orders
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Provider Communication
  	ONC PROVIDER COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	eCrCl to be calculated from serum creatinine using the Cockcroft-Gault formula.
			Nursing Orders
  	ONC NURSING COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Abbreviated exam before dosing on D1 of every cycle must be performed by a physician or a qualified delegate. Must include and at minimum: 
o General appearance; 
o Skin (paleness, jaundice, redness/rash, acneiform changes); 
o Ears, eyes (jaundice, inflammation) nose, throat (presence of petechial bleedings, gingival bleeding); 
o Lungs; 
o Heart;  
o Abdomen (pain, tenderness, peristaltic, ascites, organomegaly); 
o Lymph nodes;  
o Extremities (petechial bleedings, ulcers, signs of thrombosis), hands and feet (signs of hand-foot syndrome/palmar-plantar erythrodysesthesia).
		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Abbreviated neurological examination to include the following assessments: 
o Section 1.14 Oculomotor testing, pupil accommodation, double images;  
o Section 1.15 Motor system: muscle strength of arms; 
o Section 1.16 Sensory system: pain and touch sensation of thighs; 
o Section 1.17 Mental Status (awareness of self and environment);  
o Section 1.18 Posture; 
o Section 1.19 Coordination: finger-to-nose and heel-to-shin test.
		  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	Other aspects/body parts or organ systems may be assessed at the Investigator's discretion.
		  	MEASURE WEIGHT	Interval: --	Occurrences: --	Comments:	Body weight measured before the start of treatment on C1D1 will be used to calculate the MT-6402 dose in all subsequent cycles. The dose must be recalculated when the body weight has changed by GREATER than or EQUAL to 10% from the baseline value; or according to institutional policies. Once a subject's weight changes by GREATER than or EQUAL to 10% and a new dose is administered, this weight is considered the new baseline. For subsequent cycles, this weight will be considered the new baseline to assess for changes in weight.
		  	ONC NURSING COMMUNICATION 8	Interval: --	Occurrences: --	Comments:	New York Heart Association: The classification of cardiac function will be performed for subjects with heart failure according to the NYHA (Section 10.6). Only applicable to subjects with heart failure.
		  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	ECOG
		  	ONC NURSING COMMUNICATION 10	Interval: --	Occurrences: --	Comments:	Adverse Event Review
		  	ONC NURSING COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	Concomitant Medication Review
			Nursing Orders
  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	o Measured after at least 5 mins of quiet rest in a sitting or semi-recumbant position
o Must include: BP (systolic and diastolic), respiratory rate, heart rate, body temperature
o When possible use the same body position and method of measurement of vital signs throughout a subject's participation in the study.
o All Cycles D8, D15, D22: 
a. Pre-dose (any time prior to start of infusion); 
b. 0.5, 1, 2 hours after start of infusion.
			Labs
  	URINALYSIS, AUTOMATED WITH MICROSCOPY	Interval: --	Occurrences: --			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --			Labs
  	AMYLASE LEVEL	Interval: --	Occurrences: --		  	LIPASE LEVEL	Interval: --	Occurrences: --			Labs
  	BILIRUBIN DIRECT	Interval: --	Occurrences: --			Labs
  	PHOSPHORUS LEVEL	Interval: --	Occurrences: --			Labs
  	URIC ACID LEVEL	Interval: --	Occurrences: --			Labs
  	LDH	Interval: --	Occurrences: --			Labs
  	CREATINE KINASE, TOTAL (CPK)	Interval: --	Occurrences: --	Comments:	Including isoenzymes, is > ULN
		  	C-REACTIVE PROTEIN	Interval: --	Occurrences: --		  	GGT	Interval: --	Occurrences: --			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mEq/L; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Treatment Conditions
  	TREATMENT CONDITIONS	Interval: --	Occurrences: --	Comments:	In the event of an unexplained clinically significant abnormal laboratory test value, the test should be repeated immediately and followed up until it has returned to the normal range and/or an adequate explanation of the abnormality is found. 
Laboratory test results will be graded according to the CTCAE v. 5.0 criteria. In general, a confirmed Grade 3 or Grade 4 abnormal laboratory test result is considered to be an AE and needs to be reported in the eCRF if at least 1 of the below criteria is met: 
1) The abnormality suggests a disease (except the disease under study) and/or organ toxicity; 
2) The abnormality is of a degree that requires active management; eg, change of dose, discontinuation of the drug, more frequent follow-up assessments, further diagnostic investigation, initiation of concomitant medication, etc. 
Confirmed Grade 2 abnormal laboratory results will be assessed on a case-by-case basis for clinical significance based upon the subject's baseline value screening, the duration of the abnormal result, the need for and type of treatment and/or further evaluation required. Abnormal laboratory test results meeting SAE criteria will be reported as such.
			Pre-Medications
  	ondansetron (ZOFRAN) 16 mg, dexAMETHasone (DECADRON) 12 mg in sodium chloride 0.9% 50 mL IVPB	Dose: 16 mg	Route: intravenous	once over 10 Minutes for 1 dose	Start: S			Ingredients:	Name	Type	Dose	Selected	Adds Vol.	ONDANSETRON HCL 2 MG/ML INTRAVENOUS SOLUTION	Medications	16 mg	Main Ingredient	No	DEXAMETHASONE SODIUM PHOSPHATE 10 MG/ML INJECTION SOLUTION	Medications	12 mg	Yes	No	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	Base	50 mL	Yes	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	Base	50 mL	No	Yes			  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	once for 1 dose	Start: S					Chemotherapy
  	ONC PROVIDER COMMUNICATION 3	Interval: --	Occurrences: --	Comments:	This schedule may be modified to Days 1, 8, and 15 or to Days 1 and 15 based on tolerability. MT-6402 doses may be administered within a 2-day window if deemed appropriate by the Investigator (protocol page 62). In Part B for subjects with clinical benefit (confirmed complete response [CR], partial response [PR] for at least 12 weeks, or stable disease [SD] for at least 24 weeks) and after agreement between the treating Investigator and the Medical Monitor, the treatment can be suspended for up to 8 weeks and later resumed if in the Investigator's opinion it is in the subject's best interest. The subject needs to attend the scheduled imaging assessment during the drug holiday.
		  	INV-MT-6402 IV (MT-6402-001/PRO00037462/ZHANG) ORDERABLE 16 mcg/kg (Treatment Plan)	Dose: 16 mcg/kg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer intravenously over 30 minutes (+/-5 minutes) using 0.2 micron inline filter for syringe and IV bag. Flush the line with NS so that the entire MT-6402 solution is administered to the patient.  Final concentration must be between 30-100mcg/mL. Prepared solution for infusion must be administered as soon as possible and within the same day. 
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.

			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only – itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Fexofenadine 180 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 – MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms – shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Fexofenadine 180 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	fexofenadine (ALLEGRA) tablet 180 mg	Dose: 180 mg	Route: oral	PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled				Day 22	Perform every 1 day x1		Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Line Flush
  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Nursing Orders
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Provider Communication
  	ONC PROVIDER COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	eCrCl to be calculated from serum creatinine using the Cockcroft-Gault formula.
			Nursing Orders
  	ONC NURSING COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Abbreviated exam before dosing on D1 of every cycle must be performed by a physician or a qualified delegate. Must include and at minimum: 
o General appearance; 
o Skin (paleness, jaundice, redness/rash, acneiform changes); 
o Ears, eyes (jaundice, inflammation) nose, throat (presence of petechial bleedings, gingival bleeding); 
o Lungs; 
o Heart;  
o Abdomen (pain, tenderness, peristaltic, ascites, organomegaly); 
o Lymph nodes;  
o Extremities (petechial bleedings, ulcers, signs of thrombosis), hands and feet (signs of hand-foot syndrome/palmar-plantar erythrodysesthesia).
		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Abbreviated neurological examination to include the following assessments: 
o Section 1.14 Oculomotor testing, pupil accommodation, double images;  
o Section 1.15 Motor system: muscle strength of arms; 
o Section 1.16 Sensory system: pain and touch sensation of thighs; 
o Section 1.17 Mental Status (awareness of self and environment);  
o Section 1.18 Posture; 
o Section 1.19 Coordination: finger-to-nose and heel-to-shin test.
		  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	Other aspects/body parts or organ systems may be assessed at the Investigator's discretion.
		  	MEASURE WEIGHT	Interval: --	Occurrences: --	Comments:	Body weight measured before the start of treatment on C1D1 will be used to calculate the MT-6402 dose in all subsequent cycles. The dose must be recalculated when the body weight has changed by GREATER than or EQUAL to 10% from the baseline value; or according to institutional policies. Once a subject's weight changes by GREATER than or EQUAL to 10% and a new dose is administered, this weight is considered the new baseline. For subsequent cycles, this weight will be considered the new baseline to assess for changes in weight.
		  	ONC NURSING COMMUNICATION 8	Interval: --	Occurrences: --	Comments:	New York Heart Association: The classification of cardiac function will be performed for subjects with heart failure according to the NYHA (Section 10.6). Only applicable to subjects with heart failure.
		  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	ECOG
		  	ONC NURSING COMMUNICATION 10	Interval: --	Occurrences: --	Comments:	Adverse Event Review
		  	ONC NURSING COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	Concomitant Medication Review
			Nursing Orders
  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	o Measured after at least 5 mins of quiet rest in a sitting or semi-recumbant position
o Must include: BP (systolic and diastolic), respiratory rate, heart rate, body temperature
o When possible use the same body position and method of measurement of vital signs throughout a subject's participation in the study.
o All Cycles D8, D15, D22: 
a. Pre-dose (any time prior to start of infusion); 
b. 0.5, 1, 2 hours after start of infusion.
			Labs
  	URINALYSIS, AUTOMATED WITH MICROSCOPY	Interval: --	Occurrences: --			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --			Labs
  	AMYLASE LEVEL	Interval: --	Occurrences: --		  	LIPASE LEVEL	Interval: --	Occurrences: --			Labs
  	BILIRUBIN DIRECT	Interval: --	Occurrences: --			Labs
  	PHOSPHORUS LEVEL	Interval: --	Occurrences: --			Labs
  	URIC ACID LEVEL	Interval: --	Occurrences: --			Labs
  	LDH	Interval: --	Occurrences: --			Labs
  	CREATINE KINASE, TOTAL (CPK)	Interval: --	Occurrences: --	Comments:	Including isoenzymes, is > ULN
		  	GGT	Interval: --	Occurrences: --			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mEq/L; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Treatment Conditions
  	TREATMENT CONDITIONS	Interval: --	Occurrences: --	Comments:	In the event of an unexplained clinically significant abnormal laboratory test value, the test should be repeated immediately and followed up until it has returned to the normal range and/or an adequate explanation of the abnormality is found. 
Laboratory test results will be graded according to the CTCAE v. 5.0 criteria. In general, a confirmed Grade 3 or Grade 4 abnormal laboratory test result is considered to be an AE and needs to be reported in the eCRF if at least 1 of the below criteria is met: 
1) The abnormality suggests a disease (except the disease under study) and/or organ toxicity; 
2) The abnormality is of a degree that requires active management; eg, change of dose, discontinuation of the drug, more frequent follow-up assessments, further diagnostic investigation, initiation of concomitant medication, etc. 
Confirmed Grade 2 abnormal laboratory results will be assessed on a case-by-case basis for clinical significance based upon the subject's baseline value screening, the duration of the abnormal result, the need for and type of treatment and/or further evaluation required. Abnormal laboratory test results meeting SAE criteria will be reported as such.
			Pre-Medications
  	ondansetron (ZOFRAN) 16 mg, dexAMETHasone (DECADRON) 12 mg in sodium chloride 0.9% 50 mL IVPB	Dose: 16 mg	Route: intravenous	once over 10 Minutes for 1 dose	Start: S			Ingredients:	Name	Type	Dose	Selected	Adds Vol.	ONDANSETRON HCL 2 MG/ML INTRAVENOUS SOLUTION	Medications	16 mg	Main Ingredient	No	DEXAMETHASONE SODIUM PHOSPHATE 10 MG/ML INJECTION SOLUTION	Medications	12 mg	Yes	No	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	Base	50 mL	Yes	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	Base	50 mL	No	Yes			  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	once for 1 dose	Start: S					Chemotherapy
  	ONC PROVIDER COMMUNICATION 3	Interval: --	Occurrences: --	Comments:	This schedule may be modified to Days 1, 8, and 15 or to Days 1 and 15 based on tolerability. MT-6402 doses may be administered within a 2-day window if deemed appropriate by the Investigator (protocol page 62). In Part B for subjects with clinical benefit (confirmed complete response [CR], partial response [PR] for at least 12 weeks, or stable disease [SD] for at least 24 weeks) and after agreement between the treating Investigator and the Medical Monitor, the treatment can be suspended for up to 8 weeks and later resumed if in the Investigator's opinion it is in the subject's best interest. The subject needs to attend the scheduled imaging assessment during the drug holiday.
		  	INV-MT-6402 IV (MT-6402-001/PRO00037462/ZHANG) ORDERABLE 16 mcg/kg (Treatment Plan)	Dose: 16 mcg/kg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer intravenously over 30 minutes (+/-5 minutes) using 0.2 micron inline filter for syringe and IV bag. Flush the line with NS so that the entire MT-6402 solution is administered to the patient.  Final concentration must be between 30-100mcg/mL. Prepared solution for infusion must be administered as soon as possible and within the same day. 
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.

			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only – itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Fexofenadine 180 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 – MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms – shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Fexofenadine 180 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	fexofenadine (ALLEGRA) tablet 180 mg	Dose: 180 mg	Route: oral	PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled					
Cycle 5	Repeat 1 time	Cycle length: 28 days	Day 1	Perform every 1 day x1		Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Line Flush
  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Nursing Orders
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Provider Communication
  	ONC PROVIDER COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	eCrCl to be calculated from serum creatinine using the Cockcroft-Gault formula.
			Nursing Orders
  	ONC NURSING COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Abbreviated exam before dosing on D1 of every cycle must be performed by a physician or a qualified delegate. Must include and at minimum: 
o General appearance; 
o Skin (paleness, jaundice, redness/rash, acneiform changes); 
o Ears, eyes (jaundice, inflammation) nose, throat (presence of petechial bleedings, gingival bleeding); 
o Lungs; 
o Heart;  
o Abdomen (pain, tenderness, peristaltic, ascites, organomegaly); 
o Lymph nodes;  
o Extremities (petechial bleedings, ulcers, signs of thrombosis), hands and feet (signs of hand-foot syndrome/palmar-plantar erythrodysesthesia).
		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Abbreviated neurological examination to include the following assessments: 
o Section 1.14 Oculomotor testing, pupil accommodation, double images;  
o Section 1.15 Motor system: muscle strength of arms; 
o Section 1.16 Sensory system: pain and touch sensation of thighs; 
o Section 1.17 Mental Status (awareness of self and environment);  
o Section 1.18 Posture; 
o Section 1.19 Coordination: finger-to-nose and heel-to-shin test.
		  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	Other aspects/body parts or organ systems may be assessed at the Investigator's discretion.
		  	MEASURE WEIGHT	Interval: --	Occurrences: --	Comments:	Body weight measured before the start of treatment on C1D1 will be used to calculate the MT-6402 dose in all subsequent cycles. The dose must be recalculated when the body weight has changed by GREATER than or EQUAL to 10% from the baseline value; or according to institutional policies. Once a subject's weight changes by GREATER than or EQUAL to 10% and a new dose is administered, this weight is considered the new baseline. For subsequent cycles, this weight will be considered the new baseline to assess for changes in weight.
		  	ONC NURSING COMMUNICATION 8	Interval: --	Occurrences: --	Comments:	New York Heart Association: The classification of cardiac function will be performed for subjects with heart failure according to the NYHA (Section 10.6). Only applicable to subjects with heart failure.
		  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	ECOG
		  	ONC NURSING COMMUNICATION 10	Interval: --	Occurrences: --	Comments:	Adverse Event Review
		  	ONC NURSING COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	Concomitant Medication Review
			Nursing Orders
  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	o Measured after at least 5 mins of quiet rest in a sitting or semi-recumbant position
o Must include: BP (systolic and diastolic), respiratory rate, heart rate, body temperature
o When possible use the same body position and method of measurement of vital signs throughout a subject's participation in the study.
o C2D1: 
a. Pre-dose (any time prior to start of infusion); 
b. 0.5, 1, 2 hours after start of infusion.
			Nursing Orders
  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	o Predose (</= 4 hr prior to start of infusion); 
o 5 mins (+/- 5mins) after end of infusion; 
o 2 hrs (+/- 10mins) after end of infusion.
			Imaging
  	TRANSTHORACIC ECHOCARDIOGRAM STRESS W DOP W CONT IF NEEDED	Interval: --	Occurrences: --	Comments:	o A pre-study LVEF assessment is acceptable if obtained within 28 days before starting study treatment. 
o Preferably full 3D ECHO or if not available, MUGA. The LVEF should be reported based on Simpson's biplane method. Results should be reported as a single value rather than a range. 
o During study: collected within 2 weeks before D1 dosing of every odd cycle (C3, C5, C7, etc).
			Labs
  	URINALYSIS, AUTOMATED WITH MICROSCOPY	Interval: --	Occurrences: --			Labs
  	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	Serum HCG 
Only applicable for WOCBP. Subjects who are postmenopausal (GREATER than 1 year since last menstrual cycle) or permanently sterilized (ie: bilateral tubal occlusion, hysterectomy,  bilateral salpingectomy) may be considered as not of reproductive potential. 
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --			Labs
  	AMYLASE LEVEL	Interval: --	Occurrences: --		  	LIPASE LEVEL	Interval: --	Occurrences: --			Labs
  	BILIRUBIN DIRECT	Interval: --	Occurrences: --			Labs
  	PHOSPHORUS LEVEL	Interval: --	Occurrences: --			Labs
  	URIC ACID LEVEL	Interval: --	Occurrences: --			Labs
  	LDH	Interval: --	Occurrences: --			Labs
  	HEMOGLOBIN A1C	Interval: --	Occurrences: --			Labs
  	CREATINE KINASE, TOTAL (CPK)	Interval: --	Occurrences: --	Comments:	Including isoenzymes, is > ULN
		  	C-REACTIVE PROTEIN	Interval: --	Occurrences: --		  	GGT	Interval: --	Occurrences: --		  	CORTISOL LEVEL, RANDOM	Interval: --	Occurrences: --		  	TSH AND FREE T4	Interval: --	Occurrences: --			Labs
  	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --		  	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Samples for PK must be drawn from a different line than that used for MT-6402 administration.
o Predose (</= 4 hr prior to start of infusion); 
o 5 mins (+/- 1min) after end of infusion; 
o 2 hr (+/- 10 mins) after end of infusion.
			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mEq/L; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Treatment Conditions
  	TREATMENT CONDITIONS	Interval: --	Occurrences: --	Comments:	In the event of an unexplained clinically significant abnormal laboratory test value, the test should be repeated immediately and followed up until it has returned to the normal range and/or an adequate explanation of the abnormality is found. 
Laboratory test results will be graded according to the CTCAE v. 5.0 criteria. In general, a confirmed Grade 3 or Grade 4 abnormal laboratory test result is considered to be an AE and needs to be reported in the eCRF if at least 1 of the below criteria is met: 
1) The abnormality suggests a disease (except the disease under study) and/or organ toxicity; 
2) The abnormality is of a degree that requires active management; eg, change of dose, discontinuation of the drug, more frequent follow-up assessments, further diagnostic investigation, initiation of concomitant medication, etc. 
Confirmed Grade 2 abnormal laboratory results will be assessed on a case-by-case basis for clinical significance based upon the subject's baseline value screening, the duration of the abnormal result, the need for and type of treatment and/or further evaluation required. Abnormal laboratory test results meeting SAE criteria will be reported as such.
			Pre-Medications
  	ondansetron (ZOFRAN) 16 mg, dexAMETHasone (DECADRON) 12 mg in sodium chloride 0.9% 50 mL IVPB	Dose: 16 mg	Route: intravenous	once over 10 Minutes for 1 dose	Start: S			Ingredients:	Name	Type	Dose	Selected	Adds Vol.	ONDANSETRON HCL 2 MG/ML INTRAVENOUS SOLUTION	Medications	16 mg	Main Ingredient	No	DEXAMETHASONE SODIUM PHOSPHATE 10 MG/ML INJECTION SOLUTION	Medications	12 mg	Yes	No	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	Base	50 mL	Yes	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	Base	50 mL	No	Yes			  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	once for 1 dose	Start: S					Chemotherapy
  	ONC PROVIDER COMMUNICATION 3	Interval: --	Occurrences: --	Comments:	This schedule may be modified to Days 1, 8, and 15 or to Days 1 and 15 based on tolerability. MT-6402 doses may be administered within a 2-day window if deemed appropriate by the Investigator (protocol page 62). In Part B for subjects with clinical benefit (confirmed complete response [CR], partial response [PR] for at least 12 weeks, or stable disease [SD] for at least 24 weeks) and after agreement between the treating Investigator and the Medical Monitor, the treatment can be suspended for up to 8 weeks and later resumed if in the Investigator's opinion it is in the subject's best interest. The subject needs to attend the scheduled imaging assessment during the drug holiday.
		  	INV-MT-6402 IV (MT-6402-001/PRO00037462/ZHANG) ORDERABLE 16 mcg/kg (Treatment Plan)	Dose: 16 mcg/kg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer intravenously over 30 minutes (+/-5 minutes) using 0.2 micron inline filter for syringe and IV bag. Flush the line with NS so that the entire MT-6402 solution is administered to the patient.  Final concentration must be between 30-100mcg/mL. Prepared solution for infusion must be administered as soon as possible and within the same day. 
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.

			Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only – itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Fexofenadine 180 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 – MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms – shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Fexofenadine 180 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	fexofenadine (ALLEGRA) tablet 180 mg	Dose: 180 mg	Route: oral	PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled				Day 8	Perform every 1 day x1		Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Line Flush
  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Nursing Orders
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Provider Communication
  	ONC PROVIDER COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	eCrCl to be calculated from serum creatinine using the Cockcroft-Gault formula.
			Nursing Orders
  	ONC NURSING COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Abbreviated exam before dosing on D1 of every cycle must be performed by a physician or a qualified delegate. Must include and at minimum: 
o General appearance; 
o Skin (paleness, jaundice, redness/rash, acneiform changes); 
o Ears, eyes (jaundice, inflammation) nose, throat (presence of petechial bleedings, gingival bleeding); 
o Lungs; 
o Heart;  
o Abdomen (pain, tenderness, peristaltic, ascites, organomegaly); 
o Lymph nodes;  
o Extremities (petechial bleedings, ulcers, signs of thrombosis), hands and feet (signs of hand-foot syndrome/palmar-plantar erythrodysesthesia).
		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Abbreviated neurological examination to include the following assessments: 
o Section 1.14 Oculomotor testing, pupil accommodation, double images;  
o Section 1.15 Motor system: muscle strength of arms; 
o Section 1.16 Sensory system: pain and touch sensation of thighs; 
o Section 1.17 Mental Status (awareness of self and environment);  
o Section 1.18 Posture; 
o Section 1.19 Coordination: finger-to-nose and heel-to-shin test.
		  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	Other aspects/body parts or organ systems may be assessed at the Investigator's discretion.
		  	MEASURE WEIGHT	Interval: --	Occurrences: --	Comments:	Body weight measured before the start of treatment on C1D1 will be used to calculate the MT-6402 dose in all subsequent cycles. The dose must be recalculated when the body weight has changed by GREATER than or EQUAL to 10% from the baseline value; or according to institutional policies. Once a subject's weight changes by GREATER than or EQUAL to 10% and a new dose is administered, this weight is considered the new baseline. For subsequent cycles, this weight will be considered the new baseline to assess for changes in weight.
		  	ONC NURSING COMMUNICATION 8	Interval: --	Occurrences: --	Comments:	New York Heart Association: The classification of cardiac function will be performed for subjects with heart failure according to the NYHA (Section 10.6). Only applicable to subjects with heart failure.
		  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	ECOG
		  	ONC NURSING COMMUNICATION 10	Interval: --	Occurrences: --	Comments:	Adverse Event Review
		  	ONC NURSING COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	Concomitant Medication Review
			Nursing Orders
  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	o Measured after at least 5 mins of quiet rest in a sitting or semi-recumbant position
o Must include: BP (systolic and diastolic), respiratory rate, heart rate, body temperature
o When possible use the same body position and method of measurement of vital signs throughout a subject's participation in the study.
o All Cycles D8, D15, D22: 
a. Pre-dose (any time prior to start of infusion); 
b. 0.5, 1, 2 hours after start of infusion.
			Labs
  	URINALYSIS, AUTOMATED WITH MICROSCOPY	Interval: --	Occurrences: --			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --			Labs
  	AMYLASE LEVEL	Interval: --	Occurrences: --		  	LIPASE LEVEL	Interval: --	Occurrences: --			Labs
  	BILIRUBIN DIRECT	Interval: --	Occurrences: --			Labs
  	PHOSPHORUS LEVEL	Interval: --	Occurrences: --			Labs
  	URIC ACID LEVEL	Interval: --	Occurrences: --			Labs
  	LDH	Interval: --	Occurrences: --			Labs
  	CREATINE KINASE, TOTAL (CPK)	Interval: --	Occurrences: --	Comments:	Including isoenzymes, is > ULN
		  	GGT	Interval: --	Occurrences: --			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mEq/L; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Treatment Conditions
  	TREATMENT CONDITIONS	Interval: --	Occurrences: --	Comments:	In the event of an unexplained clinically significant abnormal laboratory test value, the test should be repeated immediately and followed up until it has returned to the normal range and/or an adequate explanation of the abnormality is found. 
Laboratory test results will be graded according to the CTCAE v. 5.0 criteria. In general, a confirmed Grade 3 or Grade 4 abnormal laboratory test result is considered to be an AE and needs to be reported in the eCRF if at least 1 of the below criteria is met: 
1) The abnormality suggests a disease (except the disease under study) and/or organ toxicity; 
2) The abnormality is of a degree that requires active management; eg, change of dose, discontinuation of the drug, more frequent follow-up assessments, further diagnostic investigation, initiation of concomitant medication, etc. 
Confirmed Grade 2 abnormal laboratory results will be assessed on a case-by-case basis for clinical significance based upon the subject's baseline value screening, the duration of the abnormal result, the need for and type of treatment and/or further evaluation required. Abnormal laboratory test results meeting SAE criteria will be reported as such.
			Pre-Medications
  	ondansetron (ZOFRAN) 16 mg, dexAMETHasone (DECADRON) 12 mg in sodium chloride 0.9% 50 mL IVPB	Dose: 16 mg	Route: intravenous	once over 10 Minutes for 1 dose	Start: S			Ingredients:	Name	Type	Dose	Selected	Adds Vol.	ONDANSETRON HCL 2 MG/ML INTRAVENOUS SOLUTION	Medications	16 mg	Main Ingredient	No	DEXAMETHASONE SODIUM PHOSPHATE 10 MG/ML INJECTION SOLUTION	Medications	12 mg	Yes	No	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	Base	50 mL	Yes	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	Base	50 mL	No	Yes			  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	once for 1 dose	Start: S					Chemotherapy
  	ONC PROVIDER COMMUNICATION 3	Interval: --	Occurrences: --	Comments:	This schedule may be modified to Days 1, 8, and 15 or to Days 1 and 15 based on tolerability. MT-6402 doses may be administered within a 2-day window if deemed appropriate by the Investigator (protocol page 62). In Part B for subjects with clinical benefit (confirmed complete response [CR], partial response [PR] for at least 12 weeks, or stable disease [SD] for at least 24 weeks) and after agreement between the treating Investigator and the Medical Monitor, the treatment can be suspended for up to 8 weeks and later resumed if in the Investigator's opinion it is in the subject's best interest. The subject needs to attend the scheduled imaging assessment during the drug holiday.
		  	INV-MT-6402 IV (MT-6402-001/PRO00037462/ZHANG) ORDERABLE 16 mcg/kg (Treatment Plan)	Dose: 16 mcg/kg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer intravenously over 30 minutes (+/-5 minutes) using 0.2 micron inline filter for syringe and IV bag. Flush the line with NS so that the entire MT-6402 solution is administered to the patient.  Final concentration must be between 30-100mcg/mL. Prepared solution for infusion must be administered as soon as possible and within the same day. 
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.

			Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only – itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Fexofenadine 180 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 – MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms – shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Fexofenadine 180 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	fexofenadine (ALLEGRA) tablet 180 mg	Dose: 180 mg	Route: oral	PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled				Day 15	Perform every 1 day x1		Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Line Flush
  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Nursing Orders
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Provider Communication
  	ONC PROVIDER COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	eCrCl to be calculated from serum creatinine using the Cockcroft-Gault formula.
			Nursing Orders
  	ONC NURSING COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Abbreviated exam before dosing on D1 of every cycle must be performed by a physician or a qualified delegate. Must include and at minimum: 
o General appearance; 
o Skin (paleness, jaundice, redness/rash, acneiform changes); 
o Ears, eyes (jaundice, inflammation) nose, throat (presence of petechial bleedings, gingival bleeding); 
o Lungs; 
o Heart;  
o Abdomen (pain, tenderness, peristaltic, ascites, organomegaly); 
o Lymph nodes;  
o Extremities (petechial bleedings, ulcers, signs of thrombosis), hands and feet (signs of hand-foot syndrome/palmar-plantar erythrodysesthesia).
		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Abbreviated neurological examination to include the following assessments: 
o Section 1.14 Oculomotor testing, pupil accommodation, double images;  
o Section 1.15 Motor system: muscle strength of arms; 
o Section 1.16 Sensory system: pain and touch sensation of thighs; 
o Section 1.17 Mental Status (awareness of self and environment);  
o Section 1.18 Posture; 
o Section 1.19 Coordination: finger-to-nose and heel-to-shin test.
		  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	Other aspects/body parts or organ systems may be assessed at the Investigator's discretion.
		  	MEASURE WEIGHT	Interval: --	Occurrences: --	Comments:	Body weight measured before the start of treatment on C1D1 will be used to calculate the MT-6402 dose in all subsequent cycles. The dose must be recalculated when the body weight has changed by GREATER than or EQUAL to 10% from the baseline value; or according to institutional policies. Once a subject's weight changes by GREATER than or EQUAL to 10% and a new dose is administered, this weight is considered the new baseline. For subsequent cycles, this weight will be considered the new baseline to assess for changes in weight.
		  	ONC NURSING COMMUNICATION 8	Interval: --	Occurrences: --	Comments:	New York Heart Association: The classification of cardiac function will be performed for subjects with heart failure according to the NYHA (Section 10.6). Only applicable to subjects with heart failure.
		  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	ECOG
		  	ONC NURSING COMMUNICATION 10	Interval: --	Occurrences: --	Comments:	Adverse Event Review
		  	ONC NURSING COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	Concomitant Medication Review
			Nursing Orders
  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	o Measured after at least 5 mins of quiet rest in a sitting or semi-recumbant position
o Must include: BP (systolic and diastolic), respiratory rate, heart rate, body temperature
o When possible use the same body position and method of measurement of vital signs throughout a subject's participation in the study.
o All Cycles D8, D15, D22: 
a. Pre-dose (any time prior to start of infusion); 
b. 0.5, 1, 2 hours after start of infusion.
			Labs
  	URINALYSIS, AUTOMATED WITH MICROSCOPY	Interval: --	Occurrences: --			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --			Labs
  	AMYLASE LEVEL	Interval: --	Occurrences: --		  	LIPASE LEVEL	Interval: --	Occurrences: --			Labs
  	BILIRUBIN DIRECT	Interval: --	Occurrences: --			Labs
  	PHOSPHORUS LEVEL	Interval: --	Occurrences: --			Labs
  	URIC ACID LEVEL	Interval: --	Occurrences: --			Labs
  	LDH	Interval: --	Occurrences: --			Labs
  	CREATINE KINASE, TOTAL (CPK)	Interval: --	Occurrences: --	Comments:	Including isoenzymes, is > ULN
		  	C-REACTIVE PROTEIN	Interval: --	Occurrences: --		  	GGT	Interval: --	Occurrences: --			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mEq/L; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Treatment Conditions
  	TREATMENT CONDITIONS	Interval: --	Occurrences: --	Comments:	In the event of an unexplained clinically significant abnormal laboratory test value, the test should be repeated immediately and followed up until it has returned to the normal range and/or an adequate explanation of the abnormality is found. 
Laboratory test results will be graded according to the CTCAE v. 5.0 criteria. In general, a confirmed Grade 3 or Grade 4 abnormal laboratory test result is considered to be an AE and needs to be reported in the eCRF if at least 1 of the below criteria is met: 
1) The abnormality suggests a disease (except the disease under study) and/or organ toxicity; 
2) The abnormality is of a degree that requires active management; eg, change of dose, discontinuation of the drug, more frequent follow-up assessments, further diagnostic investigation, initiation of concomitant medication, etc. 
Confirmed Grade 2 abnormal laboratory results will be assessed on a case-by-case basis for clinical significance based upon the subject's baseline value screening, the duration of the abnormal result, the need for and type of treatment and/or further evaluation required. Abnormal laboratory test results meeting SAE criteria will be reported as such.
			Pre-Medications
  	ondansetron (ZOFRAN) 16 mg, dexAMETHasone (DECADRON) 12 mg in sodium chloride 0.9% 50 mL IVPB	Dose: 16 mg	Route: intravenous	once over 10 Minutes for 1 dose	Start: S			Ingredients:	Name	Type	Dose	Selected	Adds Vol.	ONDANSETRON HCL 2 MG/ML INTRAVENOUS SOLUTION	Medications	16 mg	Main Ingredient	No	DEXAMETHASONE SODIUM PHOSPHATE 10 MG/ML INJECTION SOLUTION	Medications	12 mg	Yes	No	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	Base	50 mL	Yes	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	Base	50 mL	No	Yes			  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	once for 1 dose	Start: S					Chemotherapy
  	ONC PROVIDER COMMUNICATION 3	Interval: --	Occurrences: --	Comments:	This schedule may be modified to Days 1, 8, and 15 or to Days 1 and 15 based on tolerability. MT-6402 doses may be administered within a 2-day window if deemed appropriate by the Investigator (protocol page 62). In Part B for subjects with clinical benefit (confirmed complete response [CR], partial response [PR] for at least 12 weeks, or stable disease [SD] for at least 24 weeks) and after agreement between the treating Investigator and the Medical Monitor, the treatment can be suspended for up to 8 weeks and later resumed if in the Investigator's opinion it is in the subject's best interest. The subject needs to attend the scheduled imaging assessment during the drug holiday.
		  	INV-MT-6402 IV (MT-6402-001/PRO00037462/ZHANG) ORDERABLE 16 mcg/kg (Treatment Plan)	Dose: 16 mcg/kg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer intravenously over 30 minutes (+/-5 minutes) using 0.2 micron inline filter for syringe and IV bag. Flush the line with NS so that the entire MT-6402 solution is administered to the patient.  Final concentration must be between 30-100mcg/mL. Prepared solution for infusion must be administered as soon as possible and within the same day. 
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.

			Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only – itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Fexofenadine 180 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 – MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms – shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Fexofenadine 180 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	fexofenadine (ALLEGRA) tablet 180 mg	Dose: 180 mg	Route: oral	PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled				Day 22	Perform every 1 day x1		Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Line Flush
  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Nursing Orders
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Provider Communication
  	ONC PROVIDER COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	eCrCl to be calculated from serum creatinine using the Cockcroft-Gault formula.
			Nursing Orders
  	ONC NURSING COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Abbreviated exam before dosing on D1 of every cycle must be performed by a physician or a qualified delegate. Must include and at minimum: 
o General appearance; 
o Skin (paleness, jaundice, redness/rash, acneiform changes); 
o Ears, eyes (jaundice, inflammation) nose, throat (presence of petechial bleedings, gingival bleeding); 
o Lungs; 
o Heart;  
o Abdomen (pain, tenderness, peristaltic, ascites, organomegaly); 
o Lymph nodes;  
o Extremities (petechial bleedings, ulcers, signs of thrombosis), hands and feet (signs of hand-foot syndrome/palmar-plantar erythrodysesthesia).
		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Abbreviated neurological examination to include the following assessments: 
o Section 1.14 Oculomotor testing, pupil accommodation, double images;  
o Section 1.15 Motor system: muscle strength of arms; 
o Section 1.16 Sensory system: pain and touch sensation of thighs; 
o Section 1.17 Mental Status (awareness of self and environment);  
o Section 1.18 Posture; 
o Section 1.19 Coordination: finger-to-nose and heel-to-shin test.
		  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	Other aspects/body parts or organ systems may be assessed at the Investigator's discretion.
		  	MEASURE WEIGHT	Interval: --	Occurrences: --	Comments:	Body weight measured before the start of treatment on C1D1 will be used to calculate the MT-6402 dose in all subsequent cycles. The dose must be recalculated when the body weight has changed by GREATER than or EQUAL to 10% from the baseline value; or according to institutional policies. Once a subject's weight changes by GREATER than or EQUAL to 10% and a new dose is administered, this weight is considered the new baseline. For subsequent cycles, this weight will be considered the new baseline to assess for changes in weight.
		  	ONC NURSING COMMUNICATION 8	Interval: --	Occurrences: --	Comments:	New York Heart Association: The classification of cardiac function will be performed for subjects with heart failure according to the NYHA (Section 10.6). Only applicable to subjects with heart failure.
		  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	ECOG
		  	ONC NURSING COMMUNICATION 10	Interval: --	Occurrences: --	Comments:	Adverse Event Review
		  	ONC NURSING COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	Concomitant Medication Review
			Nursing Orders
  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	o Measured after at least 5 mins of quiet rest in a sitting or semi-recumbant position
o Must include: BP (systolic and diastolic), respiratory rate, heart rate, body temperature
o When possible use the same body position and method of measurement of vital signs throughout a subject's participation in the study.
o All Cycles D8, D15, D22: 
a. Pre-dose (any time prior to start of infusion); 
b. 0.5, 1, 2 hours after start of infusion.
			Labs
  	URINALYSIS, AUTOMATED WITH MICROSCOPY	Interval: --	Occurrences: --			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --			Labs
  	AMYLASE LEVEL	Interval: --	Occurrences: --		  	LIPASE LEVEL	Interval: --	Occurrences: --			Labs
  	BILIRUBIN DIRECT	Interval: --	Occurrences: --			Labs
  	PHOSPHORUS LEVEL	Interval: --	Occurrences: --			Labs
  	URIC ACID LEVEL	Interval: --	Occurrences: --			Labs
  	LDH	Interval: --	Occurrences: --			Labs
  	CREATINE KINASE, TOTAL (CPK)	Interval: --	Occurrences: --	Comments:	Including isoenzymes, is > ULN
		  	GGT	Interval: --	Occurrences: --			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mEq/L; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Treatment Conditions
  	TREATMENT CONDITIONS	Interval: --	Occurrences: --	Comments:	In the event of an unexplained clinically significant abnormal laboratory test value, the test should be repeated immediately and followed up until it has returned to the normal range and/or an adequate explanation of the abnormality is found. 
Laboratory test results will be graded according to the CTCAE v. 5.0 criteria. In general, a confirmed Grade 3 or Grade 4 abnormal laboratory test result is considered to be an AE and needs to be reported in the eCRF if at least 1 of the below criteria is met: 
1) The abnormality suggests a disease (except the disease under study) and/or organ toxicity; 
2) The abnormality is of a degree that requires active management; eg, change of dose, discontinuation of the drug, more frequent follow-up assessments, further diagnostic investigation, initiation of concomitant medication, etc. 
Confirmed Grade 2 abnormal laboratory results will be assessed on a case-by-case basis for clinical significance based upon the subject's baseline value screening, the duration of the abnormal result, the need for and type of treatment and/or further evaluation required. Abnormal laboratory test results meeting SAE criteria will be reported as such.
			Pre-Medications
  	ondansetron (ZOFRAN) 16 mg, dexAMETHasone (DECADRON) 12 mg in sodium chloride 0.9% 50 mL IVPB	Dose: 16 mg	Route: intravenous	once over 10 Minutes for 1 dose	Start: S			Ingredients:	Name	Type	Dose	Selected	Adds Vol.	ONDANSETRON HCL 2 MG/ML INTRAVENOUS SOLUTION	Medications	16 mg	Main Ingredient	No	DEXAMETHASONE SODIUM PHOSPHATE 10 MG/ML INJECTION SOLUTION	Medications	12 mg	Yes	No	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	Base	50 mL	Yes	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	Base	50 mL	No	Yes			  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	once for 1 dose	Start: S					Chemotherapy
  	ONC PROVIDER COMMUNICATION 3	Interval: --	Occurrences: --	Comments:	This schedule may be modified to Days 1, 8, and 15 or to Days 1 and 15 based on tolerability. MT-6402 doses may be administered within a 2-day window if deemed appropriate by the Investigator (protocol page 62). In Part B for subjects with clinical benefit (confirmed complete response [CR], partial response [PR] for at least 12 weeks, or stable disease [SD] for at least 24 weeks) and after agreement between the treating Investigator and the Medical Monitor, the treatment can be suspended for up to 8 weeks and later resumed if in the Investigator's opinion it is in the subject's best interest. The subject needs to attend the scheduled imaging assessment during the drug holiday.
		  	INV-MT-6402 IV (MT-6402-001/PRO00037462/ZHANG) ORDERABLE 16 mcg/kg (Treatment Plan)	Dose: 16 mcg/kg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer intravenously over 30 minutes (+/-5 minutes) using 0.2 micron inline filter for syringe and IV bag. Flush the line with NS so that the entire MT-6402 solution is administered to the patient.  Final concentration must be between 30-100mcg/mL. Prepared solution for infusion must be administered as soon as possible and within the same day. 
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.

			Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only – itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Fexofenadine 180 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 – MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms – shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Fexofenadine 180 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	fexofenadine (ALLEGRA) tablet 180 mg	Dose: 180 mg	Route: oral	PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled					
Cycle 6	Repeat 1 time	Cycle length: 28 days	Day 1	Perform every 1 day x1		Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Line Flush
  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Nursing Orders
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Provider Communication
  	ONC PROVIDER COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	eCrCl to be calculated from serum creatinine using the Cockcroft-Gault formula.
			Nursing Orders
  	ONC NURSING COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Abbreviated exam before dosing on D1 of every cycle must be performed by a physician or a qualified delegate. Must include and at minimum: 
o General appearance; 
o Skin (paleness, jaundice, redness/rash, acneiform changes); 
o Ears, eyes (jaundice, inflammation) nose, throat (presence of petechial bleedings, gingival bleeding); 
o Lungs; 
o Heart;  
o Abdomen (pain, tenderness, peristaltic, ascites, organomegaly); 
o Lymph nodes;  
o Extremities (petechial bleedings, ulcers, signs of thrombosis), hands and feet (signs of hand-foot syndrome/palmar-plantar erythrodysesthesia).
		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Abbreviated neurological examination to include the following assessments: 
o Section 1.14 Oculomotor testing, pupil accommodation, double images;  
o Section 1.15 Motor system: muscle strength of arms; 
o Section 1.16 Sensory system: pain and touch sensation of thighs; 
o Section 1.17 Mental Status (awareness of self and environment);  
o Section 1.18 Posture; 
o Section 1.19 Coordination: finger-to-nose and heel-to-shin test.
		  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	Other aspects/body parts or organ systems may be assessed at the Investigator's discretion.
		  	MEASURE WEIGHT	Interval: --	Occurrences: --	Comments:	Body weight measured before the start of treatment on C1D1 will be used to calculate the MT-6402 dose in all subsequent cycles. The dose must be recalculated when the body weight has changed by GREATER than or EQUAL to 10% from the baseline value; or according to institutional policies. Once a subject's weight changes by GREATER than or EQUAL to 10% and a new dose is administered, this weight is considered the new baseline. For subsequent cycles, this weight will be considered the new baseline to assess for changes in weight.
		  	ONC NURSING COMMUNICATION 8	Interval: --	Occurrences: --	Comments:	New York Heart Association: The classification of cardiac function will be performed for subjects with heart failure according to the NYHA (Section 10.6). Only applicable to subjects with heart failure.
		  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	ECOG
		  	ONC NURSING COMMUNICATION 10	Interval: --	Occurrences: --	Comments:	Adverse Event Review
		  	ONC NURSING COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	Concomitant Medication Review
			Nursing Orders
  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	o Measured after at least 5 mins of quiet rest in a sitting or semi-recumbant position
o Must include: BP (systolic and diastolic), respiratory rate, heart rate, body temperature
o When possible use the same body position and method of measurement of vital signs throughout a subject's participation in the study.
o C2D1: 
a. Pre-dose (any time prior to start of infusion); 
b. 0.5, 1, 2 hours after start of infusion.
			Nursing Orders
  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	o Predose (</= 4 hr prior to start of infusion); 
o 5 mins (+/- 5mins) after end of infusion; 
o 2 hrs (+/- 10mins) after end of infusion.
			Labs
  	URINALYSIS, AUTOMATED WITH MICROSCOPY	Interval: --	Occurrences: --			Labs
  	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	Serum HCG 
Only applicable for WOCBP. Subjects who are postmenopausal (GREATER than 1 year since last menstrual cycle) or permanently sterilized (ie: bilateral tubal occlusion, hysterectomy,  bilateral salpingectomy) may be considered as not of reproductive potential. 
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --			Labs
  	AMYLASE LEVEL	Interval: --	Occurrences: --		  	LIPASE LEVEL	Interval: --	Occurrences: --			Labs
  	BILIRUBIN DIRECT	Interval: --	Occurrences: --			Labs
  	PHOSPHORUS LEVEL	Interval: --	Occurrences: --			Labs
  	URIC ACID LEVEL	Interval: --	Occurrences: --			Labs
  	LDH	Interval: --	Occurrences: --			Labs
  	CREATINE KINASE, TOTAL (CPK)	Interval: --	Occurrences: --	Comments:	Including isoenzymes, is > ULN
		  	C-REACTIVE PROTEIN	Interval: --	Occurrences: --		  	GGT	Interval: --	Occurrences: --		  	CORTISOL LEVEL, RANDOM	Interval: --	Occurrences: --		  	TSH AND FREE T4	Interval: --	Occurrences: --			Labs
  	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --		  	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Samples for PK must be drawn from a different line than that used for MT-6402 administration.
o Predose (</= 4 hr prior to start of infusion); 
o 5 mins (+/- 1min) after end of infusion; 
o 2 hr (+/- 10 mins) after end of infusion.
			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mEq/L; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Treatment Conditions
  	TREATMENT CONDITIONS	Interval: --	Occurrences: --	Comments:	In the event of an unexplained clinically significant abnormal laboratory test value, the test should be repeated immediately and followed up until it has returned to the normal range and/or an adequate explanation of the abnormality is found. 
Laboratory test results will be graded according to the CTCAE v. 5.0 criteria. In general, a confirmed Grade 3 or Grade 4 abnormal laboratory test result is considered to be an AE and needs to be reported in the eCRF if at least 1 of the below criteria is met: 
1) The abnormality suggests a disease (except the disease under study) and/or organ toxicity; 
2) The abnormality is of a degree that requires active management; eg, change of dose, discontinuation of the drug, more frequent follow-up assessments, further diagnostic investigation, initiation of concomitant medication, etc. 
Confirmed Grade 2 abnormal laboratory results will be assessed on a case-by-case basis for clinical significance based upon the subject's baseline value screening, the duration of the abnormal result, the need for and type of treatment and/or further evaluation required. Abnormal laboratory test results meeting SAE criteria will be reported as such.
			Pre-Medications
  	ondansetron (ZOFRAN) 16 mg, dexAMETHasone (DECADRON) 12 mg in sodium chloride 0.9% 50 mL IVPB	Dose: 16 mg	Route: intravenous	once over 10 Minutes for 1 dose	Start: S			Ingredients:	Name	Type	Dose	Selected	Adds Vol.	ONDANSETRON HCL 2 MG/ML INTRAVENOUS SOLUTION	Medications	16 mg	Main Ingredient	No	DEXAMETHASONE SODIUM PHOSPHATE 10 MG/ML INJECTION SOLUTION	Medications	12 mg	Yes	No	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	Base	50 mL	Yes	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	Base	50 mL	No	Yes			  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	once for 1 dose	Start: S					Chemotherapy
  	ONC PROVIDER COMMUNICATION 3	Interval: --	Occurrences: --	Comments:	This schedule may be modified to Days 1, 8, and 15 or to Days 1 and 15 based on tolerability. MT-6402 doses may be administered within a 2-day window if deemed appropriate by the Investigator (protocol page 62). In Part B for subjects with clinical benefit (confirmed complete response [CR], partial response [PR] for at least 12 weeks, or stable disease [SD] for at least 24 weeks) and after agreement between the treating Investigator and the Medical Monitor, the treatment can be suspended for up to 8 weeks and later resumed if in the Investigator's opinion it is in the subject's best interest. The subject needs to attend the scheduled imaging assessment during the drug holiday.
		  	INV-MT-6402 IV (MT-6402-001/PRO00037462/ZHANG) ORDERABLE 16 mcg/kg (Treatment Plan)	Dose: 16 mcg/kg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer intravenously over 30 minutes (+/-5 minutes) using 0.2 micron inline filter for syringe and IV bag. Flush the line with NS so that the entire MT-6402 solution is administered to the patient.  Final concentration must be between 30-100mcg/mL. Prepared solution for infusion must be administered as soon as possible and within the same day. 
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.

			Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only – itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Fexofenadine 180 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 – MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms – shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Fexofenadine 180 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	fexofenadine (ALLEGRA) tablet 180 mg	Dose: 180 mg	Route: oral	PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled				Day 8	Perform every 1 day x1		Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Line Flush
  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Nursing Orders
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Provider Communication
  	ONC PROVIDER COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	eCrCl to be calculated from serum creatinine using the Cockcroft-Gault formula.
			Nursing Orders
  	ONC NURSING COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Abbreviated exam before dosing on D1 of every cycle must be performed by a physician or a qualified delegate. Must include and at minimum: 
o General appearance; 
o Skin (paleness, jaundice, redness/rash, acneiform changes); 
o Ears, eyes (jaundice, inflammation) nose, throat (presence of petechial bleedings, gingival bleeding); 
o Lungs; 
o Heart;  
o Abdomen (pain, tenderness, peristaltic, ascites, organomegaly); 
o Lymph nodes;  
o Extremities (petechial bleedings, ulcers, signs of thrombosis), hands and feet (signs of hand-foot syndrome/palmar-plantar erythrodysesthesia).
		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Abbreviated neurological examination to include the following assessments: 
o Section 1.14 Oculomotor testing, pupil accommodation, double images;  
o Section 1.15 Motor system: muscle strength of arms; 
o Section 1.16 Sensory system: pain and touch sensation of thighs; 
o Section 1.17 Mental Status (awareness of self and environment);  
o Section 1.18 Posture; 
o Section 1.19 Coordination: finger-to-nose and heel-to-shin test.
		  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	Other aspects/body parts or organ systems may be assessed at the Investigator's discretion.
		  	MEASURE WEIGHT	Interval: --	Occurrences: --	Comments:	Body weight measured before the start of treatment on C1D1 will be used to calculate the MT-6402 dose in all subsequent cycles. The dose must be recalculated when the body weight has changed by GREATER than or EQUAL to 10% from the baseline value; or according to institutional policies. Once a subject's weight changes by GREATER than or EQUAL to 10% and a new dose is administered, this weight is considered the new baseline. For subsequent cycles, this weight will be considered the new baseline to assess for changes in weight.
		  	ONC NURSING COMMUNICATION 8	Interval: --	Occurrences: --	Comments:	New York Heart Association: The classification of cardiac function will be performed for subjects with heart failure according to the NYHA (Section 10.6). Only applicable to subjects with heart failure.
		  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	ECOG
		  	ONC NURSING COMMUNICATION 10	Interval: --	Occurrences: --	Comments:	Adverse Event Review
		  	ONC NURSING COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	Concomitant Medication Review
			Nursing Orders
  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	o Measured after at least 5 mins of quiet rest in a sitting or semi-recumbant position
o Must include: BP (systolic and diastolic), respiratory rate, heart rate, body temperature
o When possible use the same body position and method of measurement of vital signs throughout a subject's participation in the study.
o All Cycles D8, D15, D22: 
a. Pre-dose (any time prior to start of infusion); 
b. 0.5, 1, 2 hours after start of infusion.
			Labs
  	URINALYSIS, AUTOMATED WITH MICROSCOPY	Interval: --	Occurrences: --			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --			Labs
  	AMYLASE LEVEL	Interval: --	Occurrences: --		  	LIPASE LEVEL	Interval: --	Occurrences: --			Labs
  	BILIRUBIN DIRECT	Interval: --	Occurrences: --			Labs
  	PHOSPHORUS LEVEL	Interval: --	Occurrences: --			Labs
  	URIC ACID LEVEL	Interval: --	Occurrences: --			Labs
  	LDH	Interval: --	Occurrences: --			Labs
  	CREATINE KINASE, TOTAL (CPK)	Interval: --	Occurrences: --	Comments:	Including isoenzymes, is > ULN
		  	GGT	Interval: --	Occurrences: --			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mEq/L; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Treatment Conditions
  	TREATMENT CONDITIONS	Interval: --	Occurrences: --	Comments:	In the event of an unexplained clinically significant abnormal laboratory test value, the test should be repeated immediately and followed up until it has returned to the normal range and/or an adequate explanation of the abnormality is found. 
Laboratory test results will be graded according to the CTCAE v. 5.0 criteria. In general, a confirmed Grade 3 or Grade 4 abnormal laboratory test result is considered to be an AE and needs to be reported in the eCRF if at least 1 of the below criteria is met: 
1) The abnormality suggests a disease (except the disease under study) and/or organ toxicity; 
2) The abnormality is of a degree that requires active management; eg, change of dose, discontinuation of the drug, more frequent follow-up assessments, further diagnostic investigation, initiation of concomitant medication, etc. 
Confirmed Grade 2 abnormal laboratory results will be assessed on a case-by-case basis for clinical significance based upon the subject's baseline value screening, the duration of the abnormal result, the need for and type of treatment and/or further evaluation required. Abnormal laboratory test results meeting SAE criteria will be reported as such.
			Pre-Medications
  	ondansetron (ZOFRAN) 16 mg, dexAMETHasone (DECADRON) 12 mg in sodium chloride 0.9% 50 mL IVPB	Dose: 16 mg	Route: intravenous	once over 10 Minutes for 1 dose	Start: S			Ingredients:	Name	Type	Dose	Selected	Adds Vol.	ONDANSETRON HCL 2 MG/ML INTRAVENOUS SOLUTION	Medications	16 mg	Main Ingredient	No	DEXAMETHASONE SODIUM PHOSPHATE 10 MG/ML INJECTION SOLUTION	Medications	12 mg	Yes	No	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	Base	50 mL	Yes	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	Base	50 mL	No	Yes			  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	once for 1 dose	Start: S					Chemotherapy
  	ONC PROVIDER COMMUNICATION 3	Interval: --	Occurrences: --	Comments:	This schedule may be modified to Days 1, 8, and 15 or to Days 1 and 15 based on tolerability. MT-6402 doses may be administered within a 2-day window if deemed appropriate by the Investigator (protocol page 62). In Part B for subjects with clinical benefit (confirmed complete response [CR], partial response [PR] for at least 12 weeks, or stable disease [SD] for at least 24 weeks) and after agreement between the treating Investigator and the Medical Monitor, the treatment can be suspended for up to 8 weeks and later resumed if in the Investigator's opinion it is in the subject's best interest. The subject needs to attend the scheduled imaging assessment during the drug holiday.
		  	INV-MT-6402 IV (MT-6402-001/PRO00037462/ZHANG) ORDERABLE 16 mcg/kg (Treatment Plan)	Dose: 16 mcg/kg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer intravenously over 30 minutes (+/-5 minutes) using 0.2 micron inline filter for syringe and IV bag. Flush the line with NS so that the entire MT-6402 solution is administered to the patient.  Final concentration must be between 30-100mcg/mL. Prepared solution for infusion must be administered as soon as possible and within the same day. 
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.

			Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only – itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Fexofenadine 180 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 – MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms – shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Fexofenadine 180 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	fexofenadine (ALLEGRA) tablet 180 mg	Dose: 180 mg	Route: oral	PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled				Day 15	Perform every 1 day x1		Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Line Flush
  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Nursing Orders
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Provider Communication
  	ONC PROVIDER COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	eCrCl to be calculated from serum creatinine using the Cockcroft-Gault formula.
			Nursing Orders
  	ONC NURSING COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Abbreviated exam before dosing on D1 of every cycle must be performed by a physician or a qualified delegate. Must include and at minimum: 
o General appearance; 
o Skin (paleness, jaundice, redness/rash, acneiform changes); 
o Ears, eyes (jaundice, inflammation) nose, throat (presence of petechial bleedings, gingival bleeding); 
o Lungs; 
o Heart;  
o Abdomen (pain, tenderness, peristaltic, ascites, organomegaly); 
o Lymph nodes;  
o Extremities (petechial bleedings, ulcers, signs of thrombosis), hands and feet (signs of hand-foot syndrome/palmar-plantar erythrodysesthesia).
		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Abbreviated neurological examination to include the following assessments: 
o Section 1.14 Oculomotor testing, pupil accommodation, double images;  
o Section 1.15 Motor system: muscle strength of arms; 
o Section 1.16 Sensory system: pain and touch sensation of thighs; 
o Section 1.17 Mental Status (awareness of self and environment);  
o Section 1.18 Posture; 
o Section 1.19 Coordination: finger-to-nose and heel-to-shin test.
		  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	Other aspects/body parts or organ systems may be assessed at the Investigator's discretion.
		  	MEASURE WEIGHT	Interval: --	Occurrences: --	Comments:	Body weight measured before the start of treatment on C1D1 will be used to calculate the MT-6402 dose in all subsequent cycles. The dose must be recalculated when the body weight has changed by GREATER than or EQUAL to 10% from the baseline value; or according to institutional policies. Once a subject's weight changes by GREATER than or EQUAL to 10% and a new dose is administered, this weight is considered the new baseline. For subsequent cycles, this weight will be considered the new baseline to assess for changes in weight.
		  	ONC NURSING COMMUNICATION 8	Interval: --	Occurrences: --	Comments:	New York Heart Association: The classification of cardiac function will be performed for subjects with heart failure according to the NYHA (Section 10.6). Only applicable to subjects with heart failure.
		  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	ECOG
		  	ONC NURSING COMMUNICATION 10	Interval: --	Occurrences: --	Comments:	Adverse Event Review
		  	ONC NURSING COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	Concomitant Medication Review
			Nursing Orders
  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	o Measured after at least 5 mins of quiet rest in a sitting or semi-recumbant position
o Must include: BP (systolic and diastolic), respiratory rate, heart rate, body temperature
o When possible use the same body position and method of measurement of vital signs throughout a subject's participation in the study.
o All Cycles D8, D15, D22: 
a. Pre-dose (any time prior to start of infusion); 
b. 0.5, 1, 2 hours after start of infusion.
			Labs
  	URINALYSIS, AUTOMATED WITH MICROSCOPY	Interval: --	Occurrences: --			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --			Labs
  	AMYLASE LEVEL	Interval: --	Occurrences: --		  	LIPASE LEVEL	Interval: --	Occurrences: --			Labs
  	BILIRUBIN DIRECT	Interval: --	Occurrences: --			Labs
  	PHOSPHORUS LEVEL	Interval: --	Occurrences: --			Labs
  	URIC ACID LEVEL	Interval: --	Occurrences: --			Labs
  	LDH	Interval: --	Occurrences: --			Labs
  	CREATINE KINASE, TOTAL (CPK)	Interval: --	Occurrences: --	Comments:	Including isoenzymes, is > ULN
		  	C-REACTIVE PROTEIN	Interval: --	Occurrences: --		  	GGT	Interval: --	Occurrences: --			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mEq/L; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Treatment Conditions
  	TREATMENT CONDITIONS	Interval: --	Occurrences: --	Comments:	In the event of an unexplained clinically significant abnormal laboratory test value, the test should be repeated immediately and followed up until it has returned to the normal range and/or an adequate explanation of the abnormality is found. 
Laboratory test results will be graded according to the CTCAE v. 5.0 criteria. In general, a confirmed Grade 3 or Grade 4 abnormal laboratory test result is considered to be an AE and needs to be reported in the eCRF if at least 1 of the below criteria is met: 
1) The abnormality suggests a disease (except the disease under study) and/or organ toxicity; 
2) The abnormality is of a degree that requires active management; eg, change of dose, discontinuation of the drug, more frequent follow-up assessments, further diagnostic investigation, initiation of concomitant medication, etc. 
Confirmed Grade 2 abnormal laboratory results will be assessed on a case-by-case basis for clinical significance based upon the subject's baseline value screening, the duration of the abnormal result, the need for and type of treatment and/or further evaluation required. Abnormal laboratory test results meeting SAE criteria will be reported as such.
			Pre-Medications
  	ondansetron (ZOFRAN) 16 mg, dexAMETHasone (DECADRON) 12 mg in sodium chloride 0.9% 50 mL IVPB	Dose: 16 mg	Route: intravenous	once over 10 Minutes for 1 dose	Start: S			Ingredients:	Name	Type	Dose	Selected	Adds Vol.	ONDANSETRON HCL 2 MG/ML INTRAVENOUS SOLUTION	Medications	16 mg	Main Ingredient	No	DEXAMETHASONE SODIUM PHOSPHATE 10 MG/ML INJECTION SOLUTION	Medications	12 mg	Yes	No	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	Base	50 mL	Yes	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	Base	50 mL	No	Yes			  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	once for 1 dose	Start: S					Chemotherapy
  	ONC PROVIDER COMMUNICATION 3	Interval: --	Occurrences: --	Comments:	This schedule may be modified to Days 1, 8, and 15 or to Days 1 and 15 based on tolerability. MT-6402 doses may be administered within a 2-day window if deemed appropriate by the Investigator (protocol page 62). In Part B for subjects with clinical benefit (confirmed complete response [CR], partial response [PR] for at least 12 weeks, or stable disease [SD] for at least 24 weeks) and after agreement between the treating Investigator and the Medical Monitor, the treatment can be suspended for up to 8 weeks and later resumed if in the Investigator's opinion it is in the subject's best interest. The subject needs to attend the scheduled imaging assessment during the drug holiday.
		  	INV-MT-6402 IV (MT-6402-001/PRO00037462/ZHANG) ORDERABLE 16 mcg/kg (Treatment Plan)	Dose: 16 mcg/kg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer intravenously over 30 minutes (+/-5 minutes) using 0.2 micron inline filter for syringe and IV bag. Flush the line with NS so that the entire MT-6402 solution is administered to the patient.  Final concentration must be between 30-100mcg/mL. Prepared solution for infusion must be administered as soon as possible and within the same day. 
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.

			Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only – itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Fexofenadine 180 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 – MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms – shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Fexofenadine 180 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	fexofenadine (ALLEGRA) tablet 180 mg	Dose: 180 mg	Route: oral	PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled				Day 22	Perform every 1 day x1		Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Line Flush
  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Nursing Orders
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Provider Communication
  	ONC PROVIDER COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	eCrCl to be calculated from serum creatinine using the Cockcroft-Gault formula.
			Nursing Orders
  	ONC NURSING COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Abbreviated exam before dosing on D1 of every cycle must be performed by a physician or a qualified delegate. Must include and at minimum: 
o General appearance; 
o Skin (paleness, jaundice, redness/rash, acneiform changes); 
o Ears, eyes (jaundice, inflammation) nose, throat (presence of petechial bleedings, gingival bleeding); 
o Lungs; 
o Heart;  
o Abdomen (pain, tenderness, peristaltic, ascites, organomegaly); 
o Lymph nodes;  
o Extremities (petechial bleedings, ulcers, signs of thrombosis), hands and feet (signs of hand-foot syndrome/palmar-plantar erythrodysesthesia).
		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Abbreviated neurological examination to include the following assessments: 
o Section 1.14 Oculomotor testing, pupil accommodation, double images;  
o Section 1.15 Motor system: muscle strength of arms; 
o Section 1.16 Sensory system: pain and touch sensation of thighs; 
o Section 1.17 Mental Status (awareness of self and environment);  
o Section 1.18 Posture; 
o Section 1.19 Coordination: finger-to-nose and heel-to-shin test.
		  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	Other aspects/body parts or organ systems may be assessed at the Investigator's discretion.
		  	MEASURE WEIGHT	Interval: --	Occurrences: --	Comments:	Body weight measured before the start of treatment on C1D1 will be used to calculate the MT-6402 dose in all subsequent cycles. The dose must be recalculated when the body weight has changed by GREATER than or EQUAL to 10% from the baseline value; or according to institutional policies. Once a subject's weight changes by GREATER than or EQUAL to 10% and a new dose is administered, this weight is considered the new baseline. For subsequent cycles, this weight will be considered the new baseline to assess for changes in weight.
		  	ONC NURSING COMMUNICATION 8	Interval: --	Occurrences: --	Comments:	New York Heart Association: The classification of cardiac function will be performed for subjects with heart failure according to the NYHA (Section 10.6). Only applicable to subjects with heart failure.
		  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	ECOG
		  	ONC NURSING COMMUNICATION 10	Interval: --	Occurrences: --	Comments:	Adverse Event Review
		  	ONC NURSING COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	Concomitant Medication Review
			Nursing Orders
  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	o Measured after at least 5 mins of quiet rest in a sitting or semi-recumbant position
o Must include: BP (systolic and diastolic), respiratory rate, heart rate, body temperature
o When possible use the same body position and method of measurement of vital signs throughout a subject's participation in the study.
o All Cycles D8, D15, D22: 
a. Pre-dose (any time prior to start of infusion); 
b. 0.5, 1, 2 hours after start of infusion.
			Labs
  	URINALYSIS, AUTOMATED WITH MICROSCOPY	Interval: --	Occurrences: --			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --			Labs
  	AMYLASE LEVEL	Interval: --	Occurrences: --		  	LIPASE LEVEL	Interval: --	Occurrences: --			Labs
  	BILIRUBIN DIRECT	Interval: --	Occurrences: --			Labs
  	PHOSPHORUS LEVEL	Interval: --	Occurrences: --			Labs
  	URIC ACID LEVEL	Interval: --	Occurrences: --			Labs
  	LDH	Interval: --	Occurrences: --			Labs
  	CREATINE KINASE, TOTAL (CPK)	Interval: --	Occurrences: --	Comments:	Including isoenzymes, is > ULN
		  	GGT	Interval: --	Occurrences: --			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mEq/L; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Treatment Conditions
  	TREATMENT CONDITIONS	Interval: --	Occurrences: --	Comments:	In the event of an unexplained clinically significant abnormal laboratory test value, the test should be repeated immediately and followed up until it has returned to the normal range and/or an adequate explanation of the abnormality is found. 
Laboratory test results will be graded according to the CTCAE v. 5.0 criteria. In general, a confirmed Grade 3 or Grade 4 abnormal laboratory test result is considered to be an AE and needs to be reported in the eCRF if at least 1 of the below criteria is met: 
1) The abnormality suggests a disease (except the disease under study) and/or organ toxicity; 
2) The abnormality is of a degree that requires active management; eg, change of dose, discontinuation of the drug, more frequent follow-up assessments, further diagnostic investigation, initiation of concomitant medication, etc. 
Confirmed Grade 2 abnormal laboratory results will be assessed on a case-by-case basis for clinical significance based upon the subject's baseline value screening, the duration of the abnormal result, the need for and type of treatment and/or further evaluation required. Abnormal laboratory test results meeting SAE criteria will be reported as such.
			Pre-Medications
  	ondansetron (ZOFRAN) 16 mg, dexAMETHasone (DECADRON) 12 mg in sodium chloride 0.9% 50 mL IVPB	Dose: 16 mg	Route: intravenous	once over 10 Minutes for 1 dose	Start: S			Ingredients:	Name	Type	Dose	Selected	Adds Vol.	ONDANSETRON HCL 2 MG/ML INTRAVENOUS SOLUTION	Medications	16 mg	Main Ingredient	No	DEXAMETHASONE SODIUM PHOSPHATE 10 MG/ML INJECTION SOLUTION	Medications	12 mg	Yes	No	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	Base	50 mL	Yes	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	Base	50 mL	No	Yes			  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	once for 1 dose	Start: S					Chemotherapy
  	ONC PROVIDER COMMUNICATION 3	Interval: --	Occurrences: --	Comments:	This schedule may be modified to Days 1, 8, and 15 or to Days 1 and 15 based on tolerability. MT-6402 doses may be administered within a 2-day window if deemed appropriate by the Investigator (protocol page 62). In Part B for subjects with clinical benefit (confirmed complete response [CR], partial response [PR] for at least 12 weeks, or stable disease [SD] for at least 24 weeks) and after agreement between the treating Investigator and the Medical Monitor, the treatment can be suspended for up to 8 weeks and later resumed if in the Investigator's opinion it is in the subject's best interest. The subject needs to attend the scheduled imaging assessment during the drug holiday.
		  	INV-MT-6402 IV (MT-6402-001/PRO00037462/ZHANG) ORDERABLE 16 mcg/kg (Treatment Plan)	Dose: 16 mcg/kg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer intravenously over 30 minutes (+/-5 minutes) using 0.2 micron inline filter for syringe and IV bag. Flush the line with NS so that the entire MT-6402 solution is administered to the patient.  Final concentration must be between 30-100mcg/mL. Prepared solution for infusion must be administered as soon as possible and within the same day. 
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.

			Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only – itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Fexofenadine 180 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 – MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms – shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Fexofenadine 180 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	fexofenadine (ALLEGRA) tablet 180 mg	Dose: 180 mg	Route: oral	PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled					
Cycle 7	Repeat 1 time	Cycle length: 28 days	Day 1	Perform every 1 day x1		Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Line Flush
  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Nursing Orders
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Provider Communication
  	ONC PROVIDER COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	eCrCl to be calculated from serum creatinine using the Cockcroft-Gault formula.
			Nursing Orders
  	ONC NURSING COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Abbreviated exam before dosing on D1 of every cycle must be performed by a physician or a qualified delegate. Must include and at minimum: 
o General appearance; 
o Skin (paleness, jaundice, redness/rash, acneiform changes); 
o Ears, eyes (jaundice, inflammation) nose, throat (presence of petechial bleedings, gingival bleeding); 
o Lungs; 
o Heart;  
o Abdomen (pain, tenderness, peristaltic, ascites, organomegaly); 
o Lymph nodes;  
o Extremities (petechial bleedings, ulcers, signs of thrombosis), hands and feet (signs of hand-foot syndrome/palmar-plantar erythrodysesthesia).
		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Abbreviated neurological examination to include the following assessments: 
o Section 1.14 Oculomotor testing, pupil accommodation, double images;  
o Section 1.15 Motor system: muscle strength of arms; 
o Section 1.16 Sensory system: pain and touch sensation of thighs; 
o Section 1.17 Mental Status (awareness of self and environment);  
o Section 1.18 Posture; 
o Section 1.19 Coordination: finger-to-nose and heel-to-shin test.
		  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	Other aspects/body parts or organ systems may be assessed at the Investigator's discretion.
		  	MEASURE WEIGHT	Interval: --	Occurrences: --	Comments:	Body weight measured before the start of treatment on C1D1 will be used to calculate the MT-6402 dose in all subsequent cycles. The dose must be recalculated when the body weight has changed by GREATER than or EQUAL to 10% from the baseline value; or according to institutional policies. Once a subject's weight changes by GREATER than or EQUAL to 10% and a new dose is administered, this weight is considered the new baseline. For subsequent cycles, this weight will be considered the new baseline to assess for changes in weight.
		  	ONC NURSING COMMUNICATION 8	Interval: --	Occurrences: --	Comments:	New York Heart Association: The classification of cardiac function will be performed for subjects with heart failure according to the NYHA (Section 10.6). Only applicable to subjects with heart failure.
		  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	ECOG
		  	ONC NURSING COMMUNICATION 10	Interval: --	Occurrences: --	Comments:	Adverse Event Review
		  	ONC NURSING COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	Concomitant Medication Review
			Nursing Orders
  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	o Measured after at least 5 mins of quiet rest in a sitting or semi-recumbant position
o Must include: BP (systolic and diastolic), respiratory rate, heart rate, body temperature
o When possible use the same body position and method of measurement of vital signs throughout a subject's participation in the study.
o C2D1: 
a. Pre-dose (any time prior to start of infusion); 
b. 0.5, 1, 2 hours after start of infusion.
			Nursing Orders
  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	o Predose (</= 4 hr prior to start of infusion); 
o 5 mins (+/- 5mins) after end of infusion; 
o 2 hrs (+/- 10mins) after end of infusion.
			Imaging
  	TRANSTHORACIC ECHOCARDIOGRAM STRESS W DOP W CONT IF NEEDED	Interval: --	Occurrences: --	Comments:	o A pre-study LVEF assessment is acceptable if obtained within 28 days before starting study treatment. 
o Preferably full 3D ECHO or if not available, MUGA. The LVEF should be reported based on Simpson's biplane method. Results should be reported as a single value rather than a range. 
o During study: collected within 2 weeks before D1 dosing of every odd cycle (C3, C5, C7, etc).
			Labs
  	URINALYSIS, AUTOMATED WITH MICROSCOPY	Interval: --	Occurrences: --			Labs
  	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	Serum HCG 
Only applicable for WOCBP. Subjects who are postmenopausal (GREATER than 1 year since last menstrual cycle) or permanently sterilized (ie: bilateral tubal occlusion, hysterectomy,  bilateral salpingectomy) may be considered as not of reproductive potential. 
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --			Labs
  	AMYLASE LEVEL	Interval: --	Occurrences: --		  	LIPASE LEVEL	Interval: --	Occurrences: --			Labs
  	BILIRUBIN DIRECT	Interval: --	Occurrences: --			Labs
  	PHOSPHORUS LEVEL	Interval: --	Occurrences: --			Labs
  	URIC ACID LEVEL	Interval: --	Occurrences: --			Labs
  	LDH	Interval: --	Occurrences: --			Labs
  	HEMOGLOBIN A1C	Interval: --	Occurrences: --			Labs
  	CREATINE KINASE, TOTAL (CPK)	Interval: --	Occurrences: --	Comments:	Including isoenzymes, is > ULN
		  	C-REACTIVE PROTEIN	Interval: --	Occurrences: --		  	GGT	Interval: --	Occurrences: --		  	CORTISOL LEVEL, RANDOM	Interval: --	Occurrences: --		  	TSH AND FREE T4	Interval: --	Occurrences: --			Labs
  	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --		  	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Samples for PK must be drawn from a different line than that used for MT-6402 administration.
o Predose (</= 4 hr prior to start of infusion); 
o 5 mins (+/- 1min) after end of infusion; 
o 2 hr (+/- 10 mins) after end of infusion.
			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mEq/L; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Treatment Conditions
  	TREATMENT CONDITIONS	Interval: --	Occurrences: --	Comments:	In the event of an unexplained clinically significant abnormal laboratory test value, the test should be repeated immediately and followed up until it has returned to the normal range and/or an adequate explanation of the abnormality is found. 
Laboratory test results will be graded according to the CTCAE v. 5.0 criteria. In general, a confirmed Grade 3 or Grade 4 abnormal laboratory test result is considered to be an AE and needs to be reported in the eCRF if at least 1 of the below criteria is met: 
1) The abnormality suggests a disease (except the disease under study) and/or organ toxicity; 
2) The abnormality is of a degree that requires active management; eg, change of dose, discontinuation of the drug, more frequent follow-up assessments, further diagnostic investigation, initiation of concomitant medication, etc. 
Confirmed Grade 2 abnormal laboratory results will be assessed on a case-by-case basis for clinical significance based upon the subject's baseline value screening, the duration of the abnormal result, the need for and type of treatment and/or further evaluation required. Abnormal laboratory test results meeting SAE criteria will be reported as such.
			Pre-Medications
  	ondansetron (ZOFRAN) 16 mg, dexAMETHasone (DECADRON) 12 mg in sodium chloride 0.9% 50 mL IVPB	Dose: 16 mg	Route: intravenous	once over 10 Minutes for 1 dose	Start: S			Ingredients:	Name	Type	Dose	Selected	Adds Vol.	ONDANSETRON HCL 2 MG/ML INTRAVENOUS SOLUTION	Medications	16 mg	Main Ingredient	No	DEXAMETHASONE SODIUM PHOSPHATE 10 MG/ML INJECTION SOLUTION	Medications	12 mg	Yes	No	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	Base	50 mL	Yes	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	Base	50 mL	No	Yes			  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	once for 1 dose	Start: S					Chemotherapy
  	ONC PROVIDER COMMUNICATION 3	Interval: --	Occurrences: --	Comments:	This schedule may be modified to Days 1, 8, and 15 or to Days 1 and 15 based on tolerability. MT-6402 doses may be administered within a 2-day window if deemed appropriate by the Investigator (protocol page 62). In Part B for subjects with clinical benefit (confirmed complete response [CR], partial response [PR] for at least 12 weeks, or stable disease [SD] for at least 24 weeks) and after agreement between the treating Investigator and the Medical Monitor, the treatment can be suspended for up to 8 weeks and later resumed if in the Investigator's opinion it is in the subject's best interest. The subject needs to attend the scheduled imaging assessment during the drug holiday.
		  	INV-MT-6402 IV (MT-6402-001/PRO00037462/ZHANG) ORDERABLE 16 mcg/kg (Treatment Plan)	Dose: 16 mcg/kg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer intravenously over 30 minutes (+/-5 minutes) using 0.2 micron inline filter for syringe and IV bag. Flush the line with NS so that the entire MT-6402 solution is administered to the patient.  Final concentration must be between 30-100mcg/mL. Prepared solution for infusion must be administered as soon as possible and within the same day. 
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.

			Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only – itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Fexofenadine 180 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 – MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms – shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Fexofenadine 180 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	fexofenadine (ALLEGRA) tablet 180 mg	Dose: 180 mg	Route: oral	PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled				Day 8	Perform every 1 day x1		Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Line Flush
  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Nursing Orders
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Provider Communication
  	ONC PROVIDER COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	eCrCl to be calculated from serum creatinine using the Cockcroft-Gault formula.
			Nursing Orders
  	ONC NURSING COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Abbreviated exam before dosing on D1 of every cycle must be performed by a physician or a qualified delegate. Must include and at minimum: 
o General appearance; 
o Skin (paleness, jaundice, redness/rash, acneiform changes); 
o Ears, eyes (jaundice, inflammation) nose, throat (presence of petechial bleedings, gingival bleeding); 
o Lungs; 
o Heart;  
o Abdomen (pain, tenderness, peristaltic, ascites, organomegaly); 
o Lymph nodes;  
o Extremities (petechial bleedings, ulcers, signs of thrombosis), hands and feet (signs of hand-foot syndrome/palmar-plantar erythrodysesthesia).
		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Abbreviated neurological examination to include the following assessments: 
o Section 1.14 Oculomotor testing, pupil accommodation, double images;  
o Section 1.15 Motor system: muscle strength of arms; 
o Section 1.16 Sensory system: pain and touch sensation of thighs; 
o Section 1.17 Mental Status (awareness of self and environment);  
o Section 1.18 Posture; 
o Section 1.19 Coordination: finger-to-nose and heel-to-shin test.
		  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	Other aspects/body parts or organ systems may be assessed at the Investigator's discretion.
		  	MEASURE WEIGHT	Interval: --	Occurrences: --	Comments:	Body weight measured before the start of treatment on C1D1 will be used to calculate the MT-6402 dose in all subsequent cycles. The dose must be recalculated when the body weight has changed by GREATER than or EQUAL to 10% from the baseline value; or according to institutional policies. Once a subject's weight changes by GREATER than or EQUAL to 10% and a new dose is administered, this weight is considered the new baseline. For subsequent cycles, this weight will be considered the new baseline to assess for changes in weight.
		  	ONC NURSING COMMUNICATION 8	Interval: --	Occurrences: --	Comments:	New York Heart Association: The classification of cardiac function will be performed for subjects with heart failure according to the NYHA (Section 10.6). Only applicable to subjects with heart failure.
		  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	ECOG
		  	ONC NURSING COMMUNICATION 10	Interval: --	Occurrences: --	Comments:	Adverse Event Review
		  	ONC NURSING COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	Concomitant Medication Review
			Nursing Orders
  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	o Measured after at least 5 mins of quiet rest in a sitting or semi-recumbant position
o Must include: BP (systolic and diastolic), respiratory rate, heart rate, body temperature
o When possible use the same body position and method of measurement of vital signs throughout a subject's participation in the study.
o All Cycles D8, D15, D22: 
a. Pre-dose (any time prior to start of infusion); 
b. 0.5, 1, 2 hours after start of infusion.
			Labs
  	URINALYSIS, AUTOMATED WITH MICROSCOPY	Interval: --	Occurrences: --			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --			Labs
  	AMYLASE LEVEL	Interval: --	Occurrences: --		  	LIPASE LEVEL	Interval: --	Occurrences: --			Labs
  	BILIRUBIN DIRECT	Interval: --	Occurrences: --			Labs
  	PHOSPHORUS LEVEL	Interval: --	Occurrences: --			Labs
  	URIC ACID LEVEL	Interval: --	Occurrences: --			Labs
  	LDH	Interval: --	Occurrences: --			Labs
  	CREATINE KINASE, TOTAL (CPK)	Interval: --	Occurrences: --	Comments:	Including isoenzymes, is > ULN
		  	GGT	Interval: --	Occurrences: --			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mEq/L; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Treatment Conditions
  	TREATMENT CONDITIONS	Interval: --	Occurrences: --	Comments:	In the event of an unexplained clinically significant abnormal laboratory test value, the test should be repeated immediately and followed up until it has returned to the normal range and/or an adequate explanation of the abnormality is found. 
Laboratory test results will be graded according to the CTCAE v. 5.0 criteria. In general, a confirmed Grade 3 or Grade 4 abnormal laboratory test result is considered to be an AE and needs to be reported in the eCRF if at least 1 of the below criteria is met: 
1) The abnormality suggests a disease (except the disease under study) and/or organ toxicity; 
2) The abnormality is of a degree that requires active management; eg, change of dose, discontinuation of the drug, more frequent follow-up assessments, further diagnostic investigation, initiation of concomitant medication, etc. 
Confirmed Grade 2 abnormal laboratory results will be assessed on a case-by-case basis for clinical significance based upon the subject's baseline value screening, the duration of the abnormal result, the need for and type of treatment and/or further evaluation required. Abnormal laboratory test results meeting SAE criteria will be reported as such.
			Pre-Medications
  	ondansetron (ZOFRAN) 16 mg, dexAMETHasone (DECADRON) 12 mg in sodium chloride 0.9% 50 mL IVPB	Dose: 16 mg	Route: intravenous	once over 10 Minutes for 1 dose	Start: S			Ingredients:	Name	Type	Dose	Selected	Adds Vol.	ONDANSETRON HCL 2 MG/ML INTRAVENOUS SOLUTION	Medications	16 mg	Main Ingredient	No	DEXAMETHASONE SODIUM PHOSPHATE 10 MG/ML INJECTION SOLUTION	Medications	12 mg	Yes	No	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	Base	50 mL	Yes	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	Base	50 mL	No	Yes			  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	once for 1 dose	Start: S					Chemotherapy
  	ONC PROVIDER COMMUNICATION 3	Interval: --	Occurrences: --	Comments:	This schedule may be modified to Days 1, 8, and 15 or to Days 1 and 15 based on tolerability. MT-6402 doses may be administered within a 2-day window if deemed appropriate by the Investigator (protocol page 62). In Part B for subjects with clinical benefit (confirmed complete response [CR], partial response [PR] for at least 12 weeks, or stable disease [SD] for at least 24 weeks) and after agreement between the treating Investigator and the Medical Monitor, the treatment can be suspended for up to 8 weeks and later resumed if in the Investigator's opinion it is in the subject's best interest. The subject needs to attend the scheduled imaging assessment during the drug holiday.
		  	INV-MT-6402 IV (MT-6402-001/PRO00037462/ZHANG) ORDERABLE 16 mcg/kg (Treatment Plan)	Dose: 16 mcg/kg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer intravenously over 30 minutes (+/-5 minutes) using 0.2 micron inline filter for syringe and IV bag. Flush the line with NS so that the entire MT-6402 solution is administered to the patient.  Final concentration must be between 30-100mcg/mL. Prepared solution for infusion must be administered as soon as possible and within the same day. 
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.

			Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only – itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Fexofenadine 180 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 – MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms – shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Fexofenadine 180 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	fexofenadine (ALLEGRA) tablet 180 mg	Dose: 180 mg	Route: oral	PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled				Day 15	Perform every 1 day x1		Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Line Flush
  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Nursing Orders
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Provider Communication
  	ONC PROVIDER COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	eCrCl to be calculated from serum creatinine using the Cockcroft-Gault formula.
			Nursing Orders
  	ONC NURSING COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Abbreviated exam before dosing on D1 of every cycle must be performed by a physician or a qualified delegate. Must include and at minimum: 
o General appearance; 
o Skin (paleness, jaundice, redness/rash, acneiform changes); 
o Ears, eyes (jaundice, inflammation) nose, throat (presence of petechial bleedings, gingival bleeding); 
o Lungs; 
o Heart;  
o Abdomen (pain, tenderness, peristaltic, ascites, organomegaly); 
o Lymph nodes;  
o Extremities (petechial bleedings, ulcers, signs of thrombosis), hands and feet (signs of hand-foot syndrome/palmar-plantar erythrodysesthesia).
		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Abbreviated neurological examination to include the following assessments: 
o Section 1.14 Oculomotor testing, pupil accommodation, double images;  
o Section 1.15 Motor system: muscle strength of arms; 
o Section 1.16 Sensory system: pain and touch sensation of thighs; 
o Section 1.17 Mental Status (awareness of self and environment);  
o Section 1.18 Posture; 
o Section 1.19 Coordination: finger-to-nose and heel-to-shin test.
		  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	Other aspects/body parts or organ systems may be assessed at the Investigator's discretion.
		  	MEASURE WEIGHT	Interval: --	Occurrences: --	Comments:	Body weight measured before the start of treatment on C1D1 will be used to calculate the MT-6402 dose in all subsequent cycles. The dose must be recalculated when the body weight has changed by GREATER than or EQUAL to 10% from the baseline value; or according to institutional policies. Once a subject's weight changes by GREATER than or EQUAL to 10% and a new dose is administered, this weight is considered the new baseline. For subsequent cycles, this weight will be considered the new baseline to assess for changes in weight.
		  	ONC NURSING COMMUNICATION 8	Interval: --	Occurrences: --	Comments:	New York Heart Association: The classification of cardiac function will be performed for subjects with heart failure according to the NYHA (Section 10.6). Only applicable to subjects with heart failure.
		  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	ECOG
		  	ONC NURSING COMMUNICATION 10	Interval: --	Occurrences: --	Comments:	Adverse Event Review
		  	ONC NURSING COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	Concomitant Medication Review
			Nursing Orders
  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	o Measured after at least 5 mins of quiet rest in a sitting or semi-recumbant position
o Must include: BP (systolic and diastolic), respiratory rate, heart rate, body temperature
o When possible use the same body position and method of measurement of vital signs throughout a subject's participation in the study.
o All Cycles D8, D15, D22: 
a. Pre-dose (any time prior to start of infusion); 
b. 0.5, 1, 2 hours after start of infusion.
			Labs
  	URINALYSIS, AUTOMATED WITH MICROSCOPY	Interval: --	Occurrences: --			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --			Labs
  	AMYLASE LEVEL	Interval: --	Occurrences: --		  	LIPASE LEVEL	Interval: --	Occurrences: --			Labs
  	BILIRUBIN DIRECT	Interval: --	Occurrences: --			Labs
  	PHOSPHORUS LEVEL	Interval: --	Occurrences: --			Labs
  	URIC ACID LEVEL	Interval: --	Occurrences: --			Labs
  	LDH	Interval: --	Occurrences: --			Labs
  	CREATINE KINASE, TOTAL (CPK)	Interval: --	Occurrences: --	Comments:	Including isoenzymes, is > ULN
		  	C-REACTIVE PROTEIN	Interval: --	Occurrences: --		  	GGT	Interval: --	Occurrences: --			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mEq/L; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Treatment Conditions
  	TREATMENT CONDITIONS	Interval: --	Occurrences: --	Comments:	In the event of an unexplained clinically significant abnormal laboratory test value, the test should be repeated immediately and followed up until it has returned to the normal range and/or an adequate explanation of the abnormality is found. 
Laboratory test results will be graded according to the CTCAE v. 5.0 criteria. In general, a confirmed Grade 3 or Grade 4 abnormal laboratory test result is considered to be an AE and needs to be reported in the eCRF if at least 1 of the below criteria is met: 
1) The abnormality suggests a disease (except the disease under study) and/or organ toxicity; 
2) The abnormality is of a degree that requires active management; eg, change of dose, discontinuation of the drug, more frequent follow-up assessments, further diagnostic investigation, initiation of concomitant medication, etc. 
Confirmed Grade 2 abnormal laboratory results will be assessed on a case-by-case basis for clinical significance based upon the subject's baseline value screening, the duration of the abnormal result, the need for and type of treatment and/or further evaluation required. Abnormal laboratory test results meeting SAE criteria will be reported as such.
			Pre-Medications
  	ondansetron (ZOFRAN) 16 mg, dexAMETHasone (DECADRON) 12 mg in sodium chloride 0.9% 50 mL IVPB	Dose: 16 mg	Route: intravenous	once over 10 Minutes for 1 dose	Start: S			Ingredients:	Name	Type	Dose	Selected	Adds Vol.	ONDANSETRON HCL 2 MG/ML INTRAVENOUS SOLUTION	Medications	16 mg	Main Ingredient	No	DEXAMETHASONE SODIUM PHOSPHATE 10 MG/ML INJECTION SOLUTION	Medications	12 mg	Yes	No	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	Base	50 mL	Yes	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	Base	50 mL	No	Yes			  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	once for 1 dose	Start: S					Chemotherapy
  	ONC PROVIDER COMMUNICATION 3	Interval: --	Occurrences: --	Comments:	This schedule may be modified to Days 1, 8, and 15 or to Days 1 and 15 based on tolerability. MT-6402 doses may be administered within a 2-day window if deemed appropriate by the Investigator (protocol page 62). In Part B for subjects with clinical benefit (confirmed complete response [CR], partial response [PR] for at least 12 weeks, or stable disease [SD] for at least 24 weeks) and after agreement between the treating Investigator and the Medical Monitor, the treatment can be suspended for up to 8 weeks and later resumed if in the Investigator's opinion it is in the subject's best interest. The subject needs to attend the scheduled imaging assessment during the drug holiday.
		  	INV-MT-6402 IV (MT-6402-001/PRO00037462/ZHANG) ORDERABLE 16 mcg/kg (Treatment Plan)	Dose: 16 mcg/kg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer intravenously over 30 minutes (+/-5 minutes) using 0.2 micron inline filter for syringe and IV bag. Flush the line with NS so that the entire MT-6402 solution is administered to the patient.  Final concentration must be between 30-100mcg/mL. Prepared solution for infusion must be administered as soon as possible and within the same day. 
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.

			Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only – itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Fexofenadine 180 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 – MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms – shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Fexofenadine 180 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	fexofenadine (ALLEGRA) tablet 180 mg	Dose: 180 mg	Route: oral	PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled				Day 22	Perform every 1 day x1		Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Line Flush
  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Nursing Orders
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Provider Communication
  	ONC PROVIDER COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	eCrCl to be calculated from serum creatinine using the Cockcroft-Gault formula.
			Nursing Orders
  	ONC NURSING COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Abbreviated exam before dosing on D1 of every cycle must be performed by a physician or a qualified delegate. Must include and at minimum: 
o General appearance; 
o Skin (paleness, jaundice, redness/rash, acneiform changes); 
o Ears, eyes (jaundice, inflammation) nose, throat (presence of petechial bleedings, gingival bleeding); 
o Lungs; 
o Heart;  
o Abdomen (pain, tenderness, peristaltic, ascites, organomegaly); 
o Lymph nodes;  
o Extremities (petechial bleedings, ulcers, signs of thrombosis), hands and feet (signs of hand-foot syndrome/palmar-plantar erythrodysesthesia).
		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Abbreviated neurological examination to include the following assessments: 
o Section 1.14 Oculomotor testing, pupil accommodation, double images;  
o Section 1.15 Motor system: muscle strength of arms; 
o Section 1.16 Sensory system: pain and touch sensation of thighs; 
o Section 1.17 Mental Status (awareness of self and environment);  
o Section 1.18 Posture; 
o Section 1.19 Coordination: finger-to-nose and heel-to-shin test.
		  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	Other aspects/body parts or organ systems may be assessed at the Investigator's discretion.
		  	MEASURE WEIGHT	Interval: --	Occurrences: --	Comments:	Body weight measured before the start of treatment on C1D1 will be used to calculate the MT-6402 dose in all subsequent cycles. The dose must be recalculated when the body weight has changed by GREATER than or EQUAL to 10% from the baseline value; or according to institutional policies. Once a subject's weight changes by GREATER than or EQUAL to 10% and a new dose is administered, this weight is considered the new baseline. For subsequent cycles, this weight will be considered the new baseline to assess for changes in weight.
		  	ONC NURSING COMMUNICATION 8	Interval: --	Occurrences: --	Comments:	New York Heart Association: The classification of cardiac function will be performed for subjects with heart failure according to the NYHA (Section 10.6). Only applicable to subjects with heart failure.
		  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	ECOG
		  	ONC NURSING COMMUNICATION 10	Interval: --	Occurrences: --	Comments:	Adverse Event Review
		  	ONC NURSING COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	Concomitant Medication Review
			Nursing Orders
  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	o Measured after at least 5 mins of quiet rest in a sitting or semi-recumbant position
o Must include: BP (systolic and diastolic), respiratory rate, heart rate, body temperature
o When possible use the same body position and method of measurement of vital signs throughout a subject's participation in the study.
o All Cycles D8, D15, D22: 
a. Pre-dose (any time prior to start of infusion); 
b. 0.5, 1, 2 hours after start of infusion.
			Labs
  	URINALYSIS, AUTOMATED WITH MICROSCOPY	Interval: --	Occurrences: --			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --			Labs
  	AMYLASE LEVEL	Interval: --	Occurrences: --		  	LIPASE LEVEL	Interval: --	Occurrences: --			Labs
  	BILIRUBIN DIRECT	Interval: --	Occurrences: --			Labs
  	PHOSPHORUS LEVEL	Interval: --	Occurrences: --			Labs
  	URIC ACID LEVEL	Interval: --	Occurrences: --			Labs
  	LDH	Interval: --	Occurrences: --			Labs
  	CREATINE KINASE, TOTAL (CPK)	Interval: --	Occurrences: --	Comments:	Including isoenzymes, is > ULN
		  	GGT	Interval: --	Occurrences: --			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mEq/L; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Treatment Conditions
  	TREATMENT CONDITIONS	Interval: --	Occurrences: --	Comments:	In the event of an unexplained clinically significant abnormal laboratory test value, the test should be repeated immediately and followed up until it has returned to the normal range and/or an adequate explanation of the abnormality is found. 
Laboratory test results will be graded according to the CTCAE v. 5.0 criteria. In general, a confirmed Grade 3 or Grade 4 abnormal laboratory test result is considered to be an AE and needs to be reported in the eCRF if at least 1 of the below criteria is met: 
1) The abnormality suggests a disease (except the disease under study) and/or organ toxicity; 
2) The abnormality is of a degree that requires active management; eg, change of dose, discontinuation of the drug, more frequent follow-up assessments, further diagnostic investigation, initiation of concomitant medication, etc. 
Confirmed Grade 2 abnormal laboratory results will be assessed on a case-by-case basis for clinical significance based upon the subject's baseline value screening, the duration of the abnormal result, the need for and type of treatment and/or further evaluation required. Abnormal laboratory test results meeting SAE criteria will be reported as such.
			Pre-Medications
  	ondansetron (ZOFRAN) 16 mg, dexAMETHasone (DECADRON) 12 mg in sodium chloride 0.9% 50 mL IVPB	Dose: 16 mg	Route: intravenous	once over 10 Minutes for 1 dose	Start: S			Ingredients:	Name	Type	Dose	Selected	Adds Vol.	ONDANSETRON HCL 2 MG/ML INTRAVENOUS SOLUTION	Medications	16 mg	Main Ingredient	No	DEXAMETHASONE SODIUM PHOSPHATE 10 MG/ML INJECTION SOLUTION	Medications	12 mg	Yes	No	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	Base	50 mL	Yes	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	Base	50 mL	No	Yes			  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	once for 1 dose	Start: S					Chemotherapy
  	ONC PROVIDER COMMUNICATION 3	Interval: --	Occurrences: --	Comments:	This schedule may be modified to Days 1, 8, and 15 or to Days 1 and 15 based on tolerability. MT-6402 doses may be administered within a 2-day window if deemed appropriate by the Investigator (protocol page 62). In Part B for subjects with clinical benefit (confirmed complete response [CR], partial response [PR] for at least 12 weeks, or stable disease [SD] for at least 24 weeks) and after agreement between the treating Investigator and the Medical Monitor, the treatment can be suspended for up to 8 weeks and later resumed if in the Investigator's opinion it is in the subject's best interest. The subject needs to attend the scheduled imaging assessment during the drug holiday.
		  	INV-MT-6402 IV (MT-6402-001/PRO00037462/ZHANG) ORDERABLE 16 mcg/kg (Treatment Plan)	Dose: 16 mcg/kg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer intravenously over 30 minutes (+/-5 minutes) using 0.2 micron inline filter for syringe and IV bag. Flush the line with NS so that the entire MT-6402 solution is administered to the patient.  Final concentration must be between 30-100mcg/mL. Prepared solution for infusion must be administered as soon as possible and within the same day. 
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.

			Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only – itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Fexofenadine 180 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 – MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms – shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Fexofenadine 180 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	fexofenadine (ALLEGRA) tablet 180 mg	Dose: 180 mg	Route: oral	PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled