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NCT07227012PHASE1, PHASE2Recruiting

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.

Pfizer

Start Date

12/1/2025

Completion Date

10/17/2028

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 Criteria

Age Range: 18 years to No maximum

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 lesions, including leptomeningeal metastasis, brainstem, meningeal, or spinal cord metastases or compression. * Clinically significant risk of hemorrhage or fistula. * Participants with any history of another malignancy within 3 years. * History of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation. * Participants with active autoimmune diseases requiring systemic treatment within the past 2 years. * Clinically significant cardiovascular disease within 6 months prior to the first dose. * Major surgery or severe trauma within 4 weeks prior to the first dose or planned major surgery during the study. * History of severe bleeding tendency or coagulation dysfunction. * History of severe ulcers, unhealed wounds, gastrointestinal perforation, abdominal fistula, gastrointestinal obstruction, intra-abdominal abscess, or acute gastrointestinal bleeding, including bleeding event due to esophageal and/or gastric varices, within 6 months prior to the first dose. * Participants with acute, chronic or symptomatic infections. * Participants with history of immunodeficiency.

Interventions

BIOLOGICAL

PF-08634404

BIOLOGICAL

Ipilimumab

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Conditions

Carcinoma, HepatocellularHepatocellular CancerHepatocellular CarcinomaUnresectable Hepatocellular CarcinomaLiver NeoplasmsAdvanced Hepatocellular CarcinomaMetastatic Hepatocellular Carcinoma

Locations

Keck Hospital of USC

Los Angeles, California 90033

United States

Los Angeles General Medical Center

Los Angeles, California 90033

United States

USC/Norris Comprehensive Cancer Center / Investigational Drug Services

Los Angeles, California 90033

United States

USC/Norris Comprehensive Cancer Center

Los Angeles, California 90033

United States

Keck Medical Center of USC Pasadena

Pasadena, California 91105

United States

Moffitt Cancer Center at Speros

Land O' Lakes, Florida 34638

United States

Moffitt Cancer Center at SouthShore

Ruskin, Florida 33570

United States

Moffitt Cancer Center - International Plaza

Tampa, Florida 33607

United States

Moffitt Cancer Center - McKinley Campus

Tampa, Florida 33612

United States

Moffitt Cancer Center

Tampa, Florida 33612

United States

Moffitt McKinley Hospital

Tampa, Florida 33612

United States

Moffitt Cancer Center at Wesley Chapel

Wesley Chapel, Florida 33544

United States

Memorial Hospital

Shiloh, Illinois 62269

United States

Siteman Cancer Center - Shiloh

Shiloh, Illinois 62269

United States

Allina Health Cancer Institute - Mercy Hospital

Coon Rapids, Minnesota 55433

United States

Allina Health Cancer Institute - Abbott Northwestern Hospital

Minneapolis, Minnesota 55407

United States

Allina Health Cancer Institute - United Hospital

Saint Paul, Minnesota 55102

United States

Siteman Cancer Center - St. Peters

City of Saint Peters, Missouri 63376

United States

Siteman Cancer Center - West County

Creve Coeur, Missouri 63141

United States

Siteman Cancer Center - North County

Florissant, Missouri 63031

United States

Saint Luke's Cancer Institute

Kansas City, Missouri 64111

United States

Saint Luke's Hospital of Kansas City

Kansas City, Missouri 64111

United States

Siteman Cancer Center

St Louis, Missouri 63108

United States

Barnes-Jewish Hospital

St Louis, Missouri 63110

United States

Washington University School of Medicine - Siteman Cancer Center

St Louis, Missouri 63110

United States

Siteman Cancer Center - South County

St Louis, Missouri 63129

United States

Renown Health Medical Oncology

Reno, Nevada 89502

United States

Renown Office of Clinical Research

Reno, Nevada 89502

United States

Renown Regional Medical Center

Reno, Nevada 89502

United States

Duke Cancer Center Cary

Cary, North Carolina 27518

United States

Duke Cancer Center - Investigational Chemotherapy Service

Durham, North Carolina 27710

United States

Duke Cancer Center

Durham, North Carolina 27710

United States

Duke University - Main Hospital and Clinics

Durham, North Carolina 27710

United States

Duke Cancer Center Raleigh

Raleigh, North Carolina 27609

United States

Virginia Mason Medical Center

Seattle, Washington 98101

United States

Fred Hutchinson Cancer Center

Seattle, Washington 98109

United States

University of Washington Medical Center- Montlake

Seattle, Washington 98195

United States

Aichi Cancer Center

Nagoya, Aichi-ken 464-8681

Japan

National Cancer Center Hospital East

Kashiwa, Chiba 277-8577

Japan

Kindai University Hospital- Osaka Medical Campus

Sakai, Osaka 590-0197

Japan

National Hospital Organization Kyushu Cancer Center

Fukuoka, 811-1395

Japan

Pan American Center for Oncology Trials, LLC - Dorado Office

Dorado, United States of America 00646

Puerto Rico

Pan American Center for Oncology Trials, LLC - Mayaguez Office

Mayagüez, United States of America 00680

Puerto Rico

Pan American Center for Oncology Trials, LLC - Ponce Office

Ponce, United States of America 00730

Puerto Rico

Pan American Center for Oncology Trials, LLC

San Juan, 00909

Puerto Rico

Taichung Veterans General Hospital

Taichung, 407

Taiwan

National Cheng Kung University Hospital

Tainan, 704

Taiwan

National Taiwan University Hospital

Taipei, 10002

Taiwan

Taipei Veterans General Hospital

Taipei, 112

Taiwan