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

  • End date
    Feb 9, 2024
  • participants needed
  • sponsor
    BioNTech Research & Development, Inc.
Updated on 9 August 2022
measurable disease
pancreatic ductal adenocarcinoma
breast ductal carcinoma


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


Open label, multicenter, non-randomized, dose escalation/expansion trial of MVT-5873 as a single agent and in combination with modified FOLFIRINOX (mFOLFIRINOX) in subjects with pancreatic and other CA19-9 positive malignancies. The study will define a Maximum Tolerated Dose (MTD) of MVT-5873 for a Q2 week schedule (Group D), an MTD of MVT-5873 for a Q4 week schedule (Group C), and an MTD for a Q2 week schedule of MVT-5873 in combination with mFOLFIRINOX (Group E). Each group will utilize a conventional 3+3 study design to identify the MTD and recommended phase 2 dose (RP2D).

Following the definition of an MTD in each group, the RP2D of MVT-5873 as a single agent and in combination with mFOLFIRINOX will be defined. Following the completion of the dose escalation phase for each group, an expansion group of up to 30 additional subjects will be treated at the RP2D for each group. In Group D, subjects will be subdivided into two groups of up to 15 subjects: subjects without peripheral blood expression of CA19-9 and subjects with peripheral blood expression of CA19-9. MVT-5873 pharmacokinetics (PK) and pharmacodynamics (PD) will be determined in each group.

Condition Pancreatic Cancer
Treatment MVT-5873, modified FOLFIRINOX (mFOLFIRINOX)
Clinical Study IdentifierNCT02672917
SponsorBioNTech Research & Development, Inc.
Last Modified on9 August 2022


Yes No Not Sure

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
Evaluable or measurable disease based on RECISTv1.1
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]
Progression following treatment with standard of care for the subject's specific tumor type
[Group C and D]
[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

Exclusion Criteria

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
Pregnant or currently breast-feeding
Psychiatric illness/social situations that would interfere with compliance with study requirements
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
Known HIV, Hepatitis B or C-positive
Significant cardiovascular risk (e.g., coronary stenting within 4 weeks, myocardial infarction within 6 months)
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