RecruitingPhase 1Phase 2NCT07227012

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

Sponsor

Pfizer

Enrollment

138 participants

Start Date

Dec 1, 2025

Study Type

INTERVENTIONAL

Conditions

Hepatocellular Carcinoma Metastatic Hepatocellular Carcinoma Unresectable Hepatocellular Carcinoma Carcinoma, Hepatocellular Advanced Hepatocellular Carcinoma Liver Neoplasms Hepatocellular Cancer

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a new drug called PF-08634404 — alone and in combination with other cancer treatments — in people with advanced liver cancer (hepatocellular carcinoma) that cannot be removed by surgery and may have spread. **You may be eligible if...** - You are 18 or older with confirmed advanced liver cancer (HCC) - Your cancer cannot be removed by surgery or local treatment - You have at least one measurable tumor - You have not received any prior systemic (whole-body) therapy for your liver cancer - Your liver function is adequate (Child-Pugh Class A) - Your general health is good (ECOG 0 or 1) **You may NOT be eligible if...** - You have moderate or severe fluid buildup in the abdomen - You have a history of brain confusion caused by liver problems (hepatic encephalopathy) - Your cancer has spread to the brain or spinal cord - You have had another cancer within the past 3 years - You have had an organ or stem cell transplant - You have active autoimmune disease - You have had major surgery or serious heart problems in the past 6 months Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALPF-08634404

Solution for infusion

BIOLOGICALIpilimumab

Solution for infusion

Locations(49)

Keck Hospital of USC

Los Angeles, California, United States

Los Angeles General Medical Center

Los Angeles, California, United States

USC/Norris Comprehensive Cancer Center / Investigational Drug Services

Los Angeles, California, United States

USC/Norris Comprehensive Cancer Center

Los Angeles, California, United States

Keck Medical Center of USC Pasadena

Pasadena, California, United States

Moffitt Cancer Center at Speros

Land O' Lakes, Florida, United States

Moffitt Cancer Center at SouthShore

Ruskin, Florida, United States

Moffitt Cancer Center - International Plaza

Tampa, Florida, United States

Moffitt Cancer Center - McKinley Campus

Tampa, Florida, United States

Moffitt Cancer Center

Tampa, Florida, United States

Moffitt McKinley Hospital

Tampa, Florida, United States

Moffitt Cancer Center at Wesley Chapel

Wesley Chapel, Florida, United States

Memorial Hospital

Shiloh, Illinois, United States

Siteman Cancer Center - Shiloh

Shiloh, Illinois, United States

Allina Health Cancer Institute - Mercy Hospital

Coon Rapids, Minnesota, United States

Allina Health Cancer Institute - Abbott Northwestern Hospital

Minneapolis, Minnesota, United States

Allina Health Cancer Institute - United Hospital

Saint Paul, Minnesota, United States

Siteman Cancer Center - St. Peters

City of Saint Peters, Missouri, United States

Siteman Cancer Center - West County

Creve Coeur, Missouri, United States

Siteman Cancer Center - North County

Florissant, Missouri, United States

Saint Luke's Cancer Institute

Kansas City, Missouri, United States

Saint Luke's Hospital of Kansas City

Kansas City, Missouri, United States

Siteman Cancer Center

St Louis, Missouri, United States

Barnes-Jewish Hospital

St Louis, Missouri, United States

Washington University School of Medicine - Siteman Cancer Center

St Louis, Missouri, United States

Siteman Cancer Center - South County

St Louis, Missouri, United States

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

Duke Cancer Center Cary

Cary, North Carolina, United States

Duke Cancer Center - Investigational Chemotherapy Service

Durham, North Carolina, United States

Duke Cancer Center

Durham, North Carolina, United States

Duke University - Main Hospital and Clinics

Durham, North Carolina, United States

Duke Cancer Center Raleigh

Raleigh, North Carolina, United States

Virginia Mason Medical Center

Seattle, Washington, United States

Fred Hutchinson Cancer Center

Seattle, Washington, United States

University of Washington Medical Center- Montlake

Seattle, Washington, United States

Aichi Cancer Center

Nagoya, Aichi-ken, Japan

National Cancer Center Hospital East

Kashiwa, Chiba, Japan

Kindai University Hospital- Osaka Medical Campus

Sakai, Osaka, Japan

National Hospital Organization Kyushu Cancer Center

Fukuoka, Japan

Pan American Center for Oncology Trials, LLC - Dorado Office

Dorado, United States of America, Puerto Rico

Pan American Center for Oncology Trials, LLC - Mayaguez Office

Mayagüez, United States of America, Puerto Rico

Pan American Center for Oncology Trials, LLC - Ponce Office

Ponce, United States of America, Puerto Rico

Pan American Center for Oncology Trials, LLC

San Juan, Puerto Rico

Taichung Veterans General Hospital

Taichung, Taiwan

National Cheng Kung University Hospital

Tainan, Taiwan

National Taiwan University Hospital

Taipei, Taiwan

Taipei Veterans General Hospital

Taipei, Taiwan

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NCT07227012

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