A Study to Evaluate the Safety and Efficacy of Pumitamig in Combination With Chemotherapy Versus Bevacizumab in Combination With Chemotherapy in Participants With Previously Untreated, Unresectable, or Metastatic Colorectal Cancer

Trial status:Will Be Recruiting
Trial ID:
CA266-0003
NCT ID:
NCT07221357
EudraCT ID:
N/A
EU Trial (CTIS) Number:
2025-523224-45
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.
Bristol-Myers Squibb
Collaborator:
BioNTech SE
Will Be Recruiting

Trial Details

The purpose of this study is to evaluate the safety and efficacy of pumitamig in combination with chemotherapy versus bevacizumab in combination with chemotherapy in participants with previously untreated, unresectable, or metastatic colorectal cancer

Medical Condition
  • Unmapped
    • Study Drug
  • Pumitamig
    • See more
  • FOLFOX
  • FOLFIRI
  • Bevacizumab
  • CAPOX
    • Phase
    Phase 2/Phase 3
    Type
    Interventional
    Estimated Enrolment
    990
    Estimated Trial Date
    Mar 2026 - Feb 2030

    Trial Participant Requirements

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

      Inclusion Criteria

    • Participant must previously untreated, histologically confirmed recurrent or metastatic colorectal adenocarcinoma, not amenable to curative surgery.
    • Participant must have no known presence of mismatch repair deficient (dMMR) or microsatellite instability-high (MSI-H) colorectal cancer (CRC) per historical results (a validated test should be used).
    • Participant must have no known presence of the gene that encodes the protein B-Raf (BRAF) V600E mutation per local testing.
    • Participant must have measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.

      • Exclusion Criteria

    • Participant must not have any untreated known central nervous system (CNS) metastases including brain, leptomeningeal and/or spinal cord compression.
    • Participant must not have any prior malignancy active within the previous 2 years, except for locally curable cancers that have been apparently cured and considered to be of low risk of recurrence.
    • Participant must not have significant cardiovascular disease, such as myocardial infarction, unstable angina, arterial thrombosis or cerebrovascular accident within 6 months prior to randomization, uncontrolled hypertension (≥ 160 systolic, ≥ 100 diastolic mm Hg) despite optimal medical management, or congenital long QT syndrome.
    • Participant must not have prior systemic treatment with an anti-PD-1, anti-programmed death (ligand)-1 (PD-L1), anti-PD-L2, CD137 agonists, or anti-cytotoxic T-lymphocyte associated protein 4 (CTLA-4) antibody, or any other antibody or drug specifically targeting T cell co-stimulation or checkpoint pathways or chemotherapy.
    • Other protocol-defined Inclusion/Exclusion criteria apply.

    Trial Locations

    Location
    Status
    Location
    Local Institution - 0263
    Los Angeles, California, United States, 90033
    Status
    Location
    Local Institution - 0345
    Orange, California, United States, 92868
    Status
    Location
    Local Institution - 0317
    Sacramento, California, United States, 95816
    Status
    Location
    Local Institution - 0293
    Stanford, California, United States, 94305
    Status
    Location
    Local Institution - 0574
    Cape Coral, Florida, United States, 33990
    Status
    Location
    Local Institution - 0575
    St. Petersburg, Florida, United States, 33705
    Status
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