Study of HuMab-5B1 (MVT-5873) in Subjects With Pancreatic Cancer or Other Cancer Antigen 19-9 (CA19-9) Positive Malignancies

This is an interventional treatment trial for Pancreatic Cancer focused on measuring CA19-9 Positive Malignancies, Pancreatic Cancer and other CA19-9 expressing malignancies, Pancreatic Ductal Adenocarcinoma (PDAC), Sialyl Lewis A (sLea) Read More

Inclusion Criteria [all groups]

• Signed, informed consent
• Age 18 or more years
• Histologically or cytologically confirmed, locally-advanced or metastatic pancreatic ductal adenocarcinoma (PDAC) or other CA19-9 positive malignancies
• Recovered from prior treatment related toxicity to at least Grade 1 with exception of Grade 2 alopecia or other Grade 2 toxicity with approval of the Medical Monitor
• Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 or KPS of 100% to 80%
• Adequate hematologic, hepatic, and renal function
• Willingness to participate in collection of pharmacokinetic samples
• Willingness to use adequate contraception throughout study and for a period of 3 months after last dose of MVT-5873

[Group A, C, and Group D Dose Escalation]

• Evaluable or measurable disease based on RECISTv1.1

[Group A, C, and D]

• Progression following treatment with standard of care for the subject's specific tumor type

[Group C and D Expansion and Group E Escalation and Expansion]

• Measurable disease based on RECISTv1.1

[Group C and D Expansion, non-PDAC malignancies]

• If serum CA19-9 levels (defined as < 1 U/mL or below the level of detection for institutional test used), subject must have confirmation of CA19-9 expression in their tumor prior to study entry (based on institutional determination of CA19-9)

[Group E]

• Candidates for mFOLFIRINOX based on accepted standard of care

[Group F]

• Histologically or cytologically confirmed PDAC
• Macroscopically complete resection (R0 or R1 resection) performed between ≥21 and ≤84 days prior to C1D1
• Baseline scans without evidence of disease (e.g., CT/MRI)
• Full recovery from surgery and able to receive chemotherapy
• Free of significant nausea and vomiting
• No prior radiotherapy or chemotherapy

Exclusion Criteria [Groups A, B, C, D, and E]

• Brain metastases unless previously treated and well controlled for at least 3 months prior to study day 1
• Other known active cancer(s) likely to require treatment in the next two (2) years
• Active, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy
• Fewer than 28 days (or 5 half-lives for systemic agents, whichever is shorter) from prior anticancer therapy including chemotherapy, hormonal, investigational, and/or biological therapies and irradiation (except for ongoing hormonal therapy for prostate cancer)
• Major surgery within 28 days of Study Day 1
• History of anaphylactic reaction to human, or humanized, antibody
• Pregnant or currently breast-feeding
• Known HIV, Hepatitis B or C-positive
• Psychiatric illness/social situations that would interfere with compliance with study requirements
• Significant cardiovascular risk (e.g., coronary stenting within 4 weeks, myocardial infarction within 6 months)

[Group F]

• Incomplete macroscopic tumor removal (R2 resection)
• Other known active cancer(s) likely to require treatment in the next 2 years
• Active, uncontrolled bacterial, viral, or fungal infection (s) requiring systemic therapy
• History of anaphylactic reaction to human, or humanized, antibody
• Pregnant or currently breast-feeding
• Known HIV, Hepatitis B or C-positive
• Psychiatric illness/social situations that would interfere with compliance with study requirements
• Significant cardiovascular risk (e.g., coronary stenting within 4 weeks, myocardial infarction within 6 months)
• Pre-existing neuropathy
• Known homozygous for UGT1A1*28 mutation
• Inflammatory disease of the colon or rectum, or occlusion or sub-occlusion of the intestine or severe postoperative uncontrolled diarrhea