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RECRUITING
NCT07227012
PHASE1/PHASE2

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.

Sponsor: Pfizer

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

138

Start Date

2025-12-01

Completion Date

2028-10-17

Last Updated

2026-04-08

Healthy Volunteers

No

Interventions

BIOLOGICAL

PF-08634404

Solution for infusion

BIOLOGICAL

Ipilimumab

Solution for infusion

Locations (8)

Renown Health Medical Oncology

Reno, Nevada, United States

Renown Office of Clinical Research

Reno, Nevada, United States

Renown Regional Medical Center

Reno, Nevada, United States

Kindai University Hospital- Osaka Medical Campus

Sakai, Osaka, Japan

National Hospital Organization Kyushu Cancer Center

Fukuoka, Japan

Pan American Center for Oncology Trials, LLC

Rio Piedras, Puerto Rico

Pan American Center for Oncology Trials, LLC

San Juan, Puerto Rico

Taipei Veterans General Hospital

Taipei, Taiwan