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

• Status: Recruiting
• Trial end date: 2023-01-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: BioNTech Research & Development, Inc.
• Treatments: Folfirinox

Criteria

Inclusion Criteria

• 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 C and Group D Dose Escalation]

• Evaluable or measurable disease based on RECISTv1.1

• Serum CA19-9 levels ≤ 4000 U/mL

[Group 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 negative 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

[Group E]

• Candidates for mFOLFIRINOX based on accepted standard of care

Exclusion Criteria

• 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)