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: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
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
Mar 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
Hammersmith Hospital
London, London, City of, United Kingdom, W12 0HS
Status
Recruiting
Location
Local Institution - 0051
Glasgow, South Western Scotland, United Kingdom, G611BD
Status
Not yet recruiting
Location
Local Institution - 0053
Metropolitan Borough of Wirral, United Kingdom, CH63 4JY
Status
Not yet recruiting