Trials / Recruiting
RecruitingNCT07227012
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.
AN INTERVENTIONAL OPEN-LABEL PHASE 1B/2 STUDY TO EVALUATE SAFETY, PHARMACOKINETICS, AND PRELIMINARY EFFICACY OF PF-08634404 AS MONOTHERAPY AND COMBINATION THERAPY IN ADULT PARTICIPANTS WITH UNRESECTABLE LOCALLY ADVANCED OR METASTATIC HEPATOCELLULAR CARCINOMA
- Status
- Recruiting
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 138 (estimated)
- Sponsor
- Pfizer · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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 treatments will take place at clinical trial sites, where trained medical staff will monitor participants during and after each visit.
Conditions
- Carcinoma, Hepatocellular
- Hepatocellular Cancer
- Hepatocellular Carcinoma
- Unresectable Hepatocellular Carcinoma
- Liver Neoplasms
- Advanced Hepatocellular Carcinoma
- Metastatic Hepatocellular Carcinoma
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | PF-08634404 | Solution for infusion |
| BIOLOGICAL | Ipilimumab | Solution for infusion |
Timeline
- Start date
- 2025-12-01
- Primary completion
- 2027-10-18
- Completion
- 2028-10-17
- First posted
- 2025-11-12
- Last updated
- 2026-04-08
Locations
8 sites across 4 countries: United States, Japan, Puerto Rico, Taiwan
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT07227012. Inclusion in this directory is not an endorsement.