Symbiotic-GI-13: A Study to Learn About Study Medicine Called PF-08634404 as a Single Trea
The purpose of this study is to learn about the effects of study medicine (PF-08634404) when given alone or with another antibody (ipilimumab) for the treatment of a type of liver cancer called hepatocellular carcinoma (HCC) that is either locally advanced (spread to nearby tissues) or has spread to other parts of the
| Condition(s) | Carcinoma, Hepatocellular, Hepatocellular Cancer, Hepatocellular Carcinoma, Unresectable Hepatocellular Carcinoma, Liver Neoplasms, Advanced Hepatocellular Carcinoma, Metastatic Hepatocellular Carcino |
|---|---|
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Study type | Interventional |
| Summary | The purpose of this study is to learn about the effects of study medicine (PF-08634404) when given alone or with another antibody (ipilimumab) for the treatment of a type of liver cancer called hepatocellular carcinoma (HCC) that is either locally advanced (spread to nearby tissues) or has spread to other parts of the body. To join the study, participants must meet the following conditions: * Be 18 years or older. * Have locally advanced or metastatic HCC. * Is not a candidate for complete surgical or loco-regional therapies. * Have not received any whole-body treatment for HCC. Participants will receive PF-08634404 either alone or in combination with ipilimumab. The medicine will be given through intravenous (IV) infusions, which means it will be administered directly into a vein. All tre |
| Who can participate | Inclusion Criteria: * 18 years of age or older at screening. * Locally advanced or metastatic HCC with diagnosis confirmed by histology/cytology or clinically by AASLD criteria (for patients with cirrhosis). Participants without cirrhosis require histological confirmation of diagnosis. * Disease that is not amenable to curative surgical and/or locoregional therapies, or progressive disease after surgical and/or locoregional therapies. * At least 1 measurable (as defined by RECIST 1.1 per investigator) and untreated lesion. * Adequate hepatic, liver, and renal function * No prior systemic therapy for HCC. * ECOG performance status 0 or 1 * Child-Pugh Class A Key Exclusion Criteria: * Moderate or severe ascites. * History of hepatic encephalopathy. * Participants with known active CNS lesion |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Pfizer |
| Locations | Land O' Lakes, Florida, United States; Ruskin, Florida, United States; Tampa, Florida, United States; Tampa, Florida, United States; Tampa, Florida, United States; Tampa, Florida, United States (+29 more sites) |
| Start date | 2025-12-01 |
| NCT ID | NCT07227012 |
| Official listing | https://clinicaltrials.gov/study/NCT07227012 |