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)
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)
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)
Liver
Phase I/II
Adults
Mol. targeted/Immunotherapy/Biologics
Atezolizumab,
Bevacizumab,
Ipilimumab,
Pumitamig
Heumann, Thatcher
International
Vanderbilt University
04-30-2026
Eligibility
18 Years and older
ALL
false
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.
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.