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

Trial status:Recruitment Complete
Trial ID:
MV-0715-CP-001.01
NCT ID:
NCT02672917
EudraCT ID:
N/A
EU Trial (CTIS) Number:
N/A
Sponsor:
The sponsor of a clinical trial is the company, institution or individual that takes responsibility for initiating, managing, and/or financing a clinical investigation. BioNTech collaborates with other pharmaceutical companies or institutions (collaborators) to develop certain new medicines. In particular cases BioNTech's collaborators are leading specific clinical trials and are acting as sponsors accordingly.
BioNTech Research & Development, Inc.
Recruitment Complete

Trial Details

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

Medical Condition
  • Pancreatic Cancer
    • Trial Drug
  • MVT-5873
    • See more
  • modified FOLFIRINOX (mFOLFIRINOX)
  • gemcitabine + nab-paclitaxel
    • Phase
    Phase 1
    Type
    Interventional
    Estimated Enrolment
    118
    Estimated Trial Date
    Jan 2016 - Aug 2024

    Trial Participant Requirements

    Age
    18+ years
    Sex
    Female & Male
    Healthy Volunteers
    No
    Inclusion and Exclusion Criteria
    Inclusion criteria

      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 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 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

    Trial Locations

    Location
    Status
    Location
    HonorHealth Research Institute
    Scottsdale, Arizona, United States, 85258
    Status
    Location
    The Angeles Clinic & Research Institute
    Los Angeles, California, United States, 90025
    Status
    Location
    Florida Cancer Specialist and Research Institute
    Sarasota, Florida, United States, 34233
    Status
    Location
    MSKCC
    New York, New York, United States, 10065
    Status
    Location
    Sarah Cannon Research Institute
    Nashville, Tennessee, United States, 37203
    Status