A Study to Evaluate the Safety and Tolerability of Pumitamig Alone or In Combination With Ipilimumab in Participants With First‑Line Advanced or Unresectable Hepatocellular Carcinoma (HCC) (ROSETTA HCC‑206)

Trial status:Will Be Recruiting
Trial ID:
CA266-0006
NCT ID:
NCT07291076
EudraCT ID:
N/A
EU Trial (CTIS) Number:
2025-523602-33
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 tolerability of Pumitamig alone or in combination with Ipilimumab in participants with first-line advanced or unresectable Hepatocellular Carcinoma (HCC)

Medical Condition
  • Liver Cancer
    • Study Drug
  • Pumitamig
    • See more
  • Ipilimumab
  • Atezolizumab
  • Bevacizumab
    • Phase
    Phase 1/Phase 2
    Type
    Interventional
    Estimated Enrolment
    129
    Estimated Trial Date
    Feb 2026 - Oct 2029

    Trial Participant Requirements

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

      Inclusion Criteria

    • Participants must have a histologically confirmed diagnosis of locally advanced or unresectable Hepatocellular Carcinoma (HCC).
    • Participants must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
    • Participants must have no prior systemic therapy for advanced/ unresectable HCC.
    • Participants must have measurable disease as per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.

      • Exclusion Criteria

    • Participants must not have significant bleeding or coagulation disorders or other obvious bleeding risk evidence.
    • Participants must not have an organ transplant or autoimmune disease.
    • Other protocol-defined Inclusion/Exclusion criteria apply.

    Trial Locations

    Location
    Status
    Location
    Local Institution - 0070
    Los Angeles, California, United States, 90064
    Status
    Location
    Local Institution - 0103
    Hackensack, New Jersey, United States, 07601
    Status
    Location
    Local Institution - 0100
    Great Neck, New York, United States, 11021
    Status
    Location
    Local Institution - 0080
    Portland, Oregon, United States, 97213
    Status
    Location
    Local Institution - 0022
    Nashville, Tennessee, United States, 37203
    Status
    Location
    Local Institution - 0102
    Nashville, Tennessee, United States, 37232
    Status
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