Phase 1b2 Study Evaluating Safety and Effectiveness of PF-08634404 Alone or With Ipilimumab in Adults With Advanced or Metastatic Liver Cancer Not Suitable for Surgery

What this Trial Is About

Researchers are studying the effects of the medicine PF-08634404, given alone or with another antibody called ipilimumab, for treating advanced liver cancer known as hepatocellular carcinoma HCC that cannot be removed by surgery or has spread to other parts of the body. This is a clinical trial that includes adults aged 18 years or older who have locally advanced or metastatic HCC and have not received whole-body treatment for this cancer. Participants will be randomly assigned to receive either PF-08634404 alone or PF-08634404 combined with ipilimumab. Both medicines are given through intravenous IV infusions directly into a vein. The study involves sequential dose levels and will be conducted at clinical trial sites where medical staff will monitor participants during and after treatment visits. During the study, participants will be monitored for side effects and overall response to treatment. Researchers will evaluate safety, pharmacokinetics, and preliminary efficacy by measuring adverse events, dose-limiting toxicities, and tumor response using RECIST 1.1 criteria. Laboratory tests and immunological assessments will be performed up to approximately 24 months to understand how the medicines behave in the body and their effects on the cancer.

Symbiotic-GI-13: A Study to Learn About Study Medicine Called PF-08634404 as a Single Treatment and Combination Treatment in Adult Participants With a Liver Cancer Called Hepatocellular Carcinoma, That is Too Advanced to be Removed by Surgery and May Have Spread to Other Parts of the Body.