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
- Carcinoma, Hepatocellular
- Hepatocellular Cancer
- Hepatocellular Carcinoma
- Unresectable Hepatocellular Carcinoma
- Liver Neoplasms
- Advanced Hepatocellular Carcinoma
- Metastatic Hepatocellular Carcinoma
At a glance
- Phase
- Phase 1
- Study type
- Interventional
- Sponsor
- Pfizer
- Enrolment target
- 138
- Started
- 1 December 2025
- Main results due
- 18 October 2027
- Study sites
- 58
- Registry updated
- 28 September 2026
Can you take part?
- Aged 18 years and over.
- Open to any sex.
- You need the condition being studied — healthy volunteers are not accepted.
These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.
Read the full eligibility criteria
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.
What this study is about
In the sponsor’s own words, from the registry.
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.
Study sites(58)
Chao Family Comprehensive Cancer Center and Ambulatory Care
Irvine, California, United States
Recruiting
UCI Health - Irvine Infusion Pharmacy ACC
Irvine, California, United States
Recruiting
UCI Health - Irvine
Irvine, California, United States
Recruiting
START Los Angeles, LLC
Los Angeles, California, United States
Recruiting
Keck Hospital of USC
Los Angeles, California, United States
Recruiting
Los Angeles General Medical Center
Los Angeles, California, United States
Recruiting
USC/Norris Comprehensive Cancer Center / Investigational Drug Services
Los Angeles, California, United States
Recruiting
USC/Norris Comprehensive Cancer Center
Los Angeles, California, United States
Recruiting
LACN Century City
Los Angeles, California, United States
Recruiting
UC Irvine Health - Chao Family Comprehensive Cancer Center
Orange, California, United States
Recruiting
Keck Medical Center of USC Pasadena
Pasadena, California, United States
Recruiting
Moffitt Cancer Center at Speros
Land O' Lakes, Florida, United States
Recruiting
Moffitt Cancer Center at SouthShore
Ruskin, Florida, United States
Recruiting
Moffitt Cancer Center - International Plaza
Tampa, Florida, United States
Recruiting
Moffitt Cancer Center - McKinley Campus
Tampa, Florida, United States
Recruiting
Moffitt Cancer Center
Tampa, Florida, United States
Recruiting
Moffitt McKinley Hospital
Tampa, Florida, United States
Recruiting
Moffitt Cancer Center at Wesley Chapel
Wesley Chapel, Florida, United States
Recruiting
Memorial Hospital
Shiloh, Illinois, United States
Recruiting
Siteman Cancer Center - Shiloh
Shiloh, Illinois, United States
Recruiting
Allina Health Cancer Institute - Mercy Hospital
Coon Rapids, Minnesota, United States
Recruiting
Allina Health Cancer Institute - Abbott Northwestern Hospital
Minneapolis, Minnesota, United States
Recruiting
Allina Health Cancer Institute - United Hospital
Saint Paul, Minnesota, United States
Recruiting
Siteman Cancer Center - St. Peters
City of Saint Peters, Missouri, United States
Recruiting
Siteman Cancer Center - West County
Creve Coeur, Missouri, United States
Recruiting
Siteman Cancer Center - North County
Florissant, Missouri, United States
Recruiting
Saint Luke's Cancer Institute
Kansas City, Missouri, United States
Recruiting
Saint Luke's Hospital of Kansas City
Kansas City, Missouri, United States
Recruiting
Siteman Cancer Center
St Louis, Missouri, United States
Recruiting
Barnes-Jewish Hospital
St Louis, Missouri, United States
Recruiting
Washington University School of Medicine - Siteman Cancer Center
St Louis, Missouri, United States
Recruiting
Siteman Cancer Center - South County
St Louis, Missouri, United States
Recruiting
Renown Health Medical Oncology
Reno, Nevada, United States
Recruiting
Renown Office of Clinical Research
Reno, Nevada, United States
Recruiting
Renown Regional Medical Center
Reno, Nevada, United States
Recruiting
Duke Cancer Center Cary
Cary, North Carolina, United States
Recruiting
Duke Cancer Center - Investigational Chemotherapy Service
Durham, North Carolina, United States
Recruiting
Duke Cancer Center
Durham, North Carolina, United States
Recruiting
Duke University - Main Hospital and Clinics
Durham, North Carolina, United States
Recruiting
Duke Cancer Center Raleigh
Raleigh, North Carolina, United States
Recruiting
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States
Recruiting
Virginia Mason Medical Center
Seattle, Washington, United States
Recruiting
Fred Hutchinson Cancer Center
Seattle, Washington, United States
Recruiting
University of Washington Medical Center- Montlake
Seattle, Washington, United States
Recruiting
Zhongshan Hospital,Fudan University
Shanghai, Shanghai Municipality, China
Recruiting
Aichi Cancer Center
Nagoya, Aichi-ken, Japan
Recruiting
National Cancer Center Hospital East
Kashiwa, Chiba, Japan
Recruiting
Kindai University Hospital- Osaka Medical Campus
Sakai, Osaka, Japan
Recruiting
National Cancer Center Hospital
Chuo-ku, Tokyo, Japan
Recruiting
National Hospital Organization Kyushu Cancer Center
Fukuoka, Japan
Recruiting
Pan American Center for Oncology Trials, LLC - Dorado Office
Dorado, United States of America, Puerto Rico
Recruiting
Pan American Center for Oncology Trials, LLC - Mayaguez Office
Mayagüez, United States of America, Puerto Rico
Recruiting
Pan American Center for Oncology Trials, LLC - Ponce Office
Ponce, United States of America, Puerto Rico
Recruiting
Pan American Center for Oncology Trials, LLC
San Juan, Puerto Rico
Recruiting
Taichung Veterans General Hospital
Taichung, Taiwan
Recruiting
National Cheng Kung University Hospital
Tainan, Taiwan
Recruiting
National Taiwan University Hospital
Taipei, Taiwan
Recruiting
Taipei Veterans General Hospital
Taipei, Taiwan
Recruiting
Showing 58 of 58 sites. 58 of the 58 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.
Source: ClinicalTrials.gov record NCT07227012. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.
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