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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
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
2026-07-06
Healthy Volunteers
No
Conditions
Interventions
PF-08634404
Solution for infusion
Ipilimumab
Solution for infusion
Locations (41)
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
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
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