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

Trial details

Who runs it

BioNTech Research & Development, Inc.

Trial code

NCT02672917

Record updated

28 January 2025

Original description

Phase 1 Safety and Tolerability Study in Subjects with Pancreatic Cancer or Other CA19-9 Positive Malignancies.Read full original descriptionShow less

Phase 1 Safety and Tolerability Study of Human Monoclonal Antibody 5B1 (MVT-5873) With Expansion in Subjects With Pancreatic Cancer or Other CA19-9 Positive Malignancies

Phase 1 Safety and Tolerability Study in Subjects with Pancreatic Cancer or Other CA19-9 Positive Malignancies.

Inclusion: 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 and for up to at least 9 months after the last Oxaliplatin dose; [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 Dose Expansion and Group E Dose Escalation and Expansion]; Measurable disease based on RECISTv1.1; [Group C and D Dose 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 and F]; 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 Cycle 1, Day 1 (C1D1); Baseline scans without evidence of disease (e.g., CT/MRI); Serum CA19-9 ≤ 180 U/mL within 21 days of C1D1; Full recovery from surgery and able to receive chemotherapy; Free of significant nausea and vomiting; No prior radiotherapy or chemotherapy.

Exclusion: Brain metastases unless previously treated and well controlled for at least 3 months prior to study day 1; 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; Incomplete macroscopic tumor removal (R2 resection); 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; History of anaphylactic reaction to human, or humanized, antibody; 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]; 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; 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); Inflammatory disease of the colon or rectum, or occlusion or sub-occlusion of the intestine or severe postoperative uncontrolled diarrhea; Pregnant or currently breast-feeding; Pregnant or currently breast-feeding; Pre-existing neuropathy; Known homozygous for UGT1A1*28 mutation.

ClinicalTrials.gov NCT02672917