MT-601 Administered To Patients With Locally Advanced Unresectable or Metastatic Pancreatic Cancer

The Dose Escalation portion of the study will use a modified 3+3 design to define an acceptable dose of MT-601 in combination with maintenance capecitabine following completion of FFX or NLX chemotherapy. For the Dose Expansion, MT-601 will be administered at the dose determined to be safe based on the results from the Dose Escalation portion. Front-line chemotherapy (FOLFIRINOX or gemcitabine/nab-paclitaxel) will be administered as per standard of care. MT-601 will be administered intravenously over no less than 5 minutes as a single dose following completion of all planned doses of FFX or NLX chemotherapy and after participants have started receiving maintenance capecitabine.

Inclusion criteria

• Informed Consent
• Age ≥ 18 years
• ECOG performance status of 0 to 1
• Cytologically or histologically confirmed, locally advanced, unresectable or metastatic pancreatic adenocarcinoma (pancreatic carcinomas with at least some component of adenocarcinoma included).
• Measurable or evaluable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
• Prior receipt of at least 4 doses (~2 months) of FFX or NLX with plans for completion of 12 doses (~6 months)
• Absence of progression during treatment with FFX or NLX (eg. CR, PR, or SD at study entry)
• Adequate pulmonary function with partial pressure of oxygen (pO2) on room air of at least 90%
• Adequate cardiac function with an ejection fraction ≥ 45%
• Adequate organ function, as defined below:

• Absolute neutrophil count (ANC) ≥1.0 × 109/L (growth factor support allowed)
• Platelets ≥75,000/mm3 (supportive medications allowed)
• Hemoglobin ≥9 gm/dL (transfusion allowed)
• Total bilirubin ≤2.0 × ULN unless considered due to Gilbert's syndrome in which case, ≤ 3.0 x ULN
• Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3.0 × ULN OR ≤5 × ULN if known tumor involvement of liver
• Serum creatinine ≤2 × ULN OR estimated glomerular filtration rate (using institutional standard) ≥50 mL/min
• Willingness to use adequate contraception throughout study and for a period of 3 months after last dose of any study drugs

Exclusion criteria

• Known CNS metastases or meningeal carcinomatosis unless treated and controlled for ≥ 3 months prior to the first administration of MT-601 without the need for increasing doses of steroids
• Other known active cancer likely to require additional treatment in the next 2 years unless approved by Medical Monitor
• Active bacterial, viral, or fungal infection requiring systemic therapy. Patients may be re-evaluated for eligibility upon completion of infection treatment.
• Significant cardiovascular risk (eg, coronary stenting within 4 weeks, myocardial infarction within 6 months)
• Diagnosis of significant immunodeficiency that in the Investigator or Medical Monitor's judgment would preclude participation in the study.
• Administration of systemic steroid therapy (> 10 mg/day of prednisone equivalent) ≤ 7 days prior to the first administration of MT-601
• Active autoimmune disease that required systemic treatment in the past 2 years (replacement therapies excluded [eg, thyroxine, insulin, physiologic corticosteroids])
• History of solid organ or hematologic transplant
• Known HIV
• Evidence of active hepatitis B as defined by:

• Positive hepatitis B surface antigen (HBsAg), or
• Negative HBsAg but a positive hepatitis B surface antibody (HBsAb) or positive hepatitis B core antibody (HBcAb) with a positive hepatitis B virus (HBV) DNA
• Evidence of active hepatitis C as defined by:

a. Positive anti-hepatitis C virus antibody (HCVAb) with a positive hepatitis C virus (HCV) RNA by PCR

• Pregnant or currently breast-feeding
• Psychiatric illness/social situations that would interfere with compliance with study requirements