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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.

RecruitingPhase 1/2

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

Who can join

Ages 18 and older · All sexes

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.

About the study

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.

What is being tested

Sponsor: Pfizer · Participants: 138 · Started: Dec 1, 2025

Contact the study team

Official record on ClinicalTrials.gov — NCT07227012

Locations in the U.S.

CaliforniaChao Family Comprehensive Cancer Center and Ambulatory Care, Irvine
UCI Health - Irvine, Irvine
UCI Health - Irvine Infusion Pharmacy ACC, Irvine
Keck Hospital of USC, Los Angeles
LACN Century City, Los Angeles
Los Angeles General Medical Center, Los Angeles
START Los Angeles, LLC, Los Angeles
USC/Norris Comprehensive Cancer Center, Los Angeles
USC/Norris Comprehensive Cancer Center / Investigational Drug Services, Los Angeles
UC Irvine Health - Chao Family Comprehensive Cancer Center, Orange
Keck Medical Center of USC Pasadena, Pasadena
FloridaMoffitt Cancer Center at Speros, Land O' Lakes
Moffitt Cancer Center at SouthShore, Ruskin
Moffitt Cancer Center, Tampa
Moffitt Cancer Center - International Plaza, Tampa
Moffitt Cancer Center - McKinley Campus, Tampa
Moffitt McKinley Hospital, Tampa
Moffitt Cancer Center at Wesley Chapel, Wesley Chapel
IllinoisMemorial Hospital, Shiloh
Siteman Cancer Center - Shiloh, Shiloh
MinnesotaAllina Health Cancer Institute - Mercy Hospital, Coon Rapids
Allina Health Cancer Institute - Abbott Northwestern Hospital, Minneapolis
Allina Health Cancer Institute - United Hospital, Saint Paul
MissouriSiteman Cancer Center - St. Peters, City of Saint Peters
Siteman Cancer Center - West County, Creve Coeur
Siteman Cancer Center - North County, Florissant
Saint Luke's Cancer Institute, Kansas City
Saint Luke's Hospital of Kansas City, Kansas City
Barnes-Jewish Hospital, St Louis
Siteman Cancer Center, St Louis
Siteman Cancer Center - South County, St Louis
Washington University School of Medicine - Siteman Cancer Center, St Louis
NevadaRenown Health Medical Oncology, Reno
Renown Office of Clinical Research, Reno
Renown Regional Medical Center, Reno
North CarolinaDuke Cancer Center Cary, Cary
Duke Cancer Center, Durham
Duke Cancer Center - Investigational Chemotherapy Service, Durham
Duke University - Main Hospital and Clinics, Durham
Duke Cancer Center Raleigh, Raleigh
OhioUniversity Hospitals Cleveland Medical Center, Cleveland
WashingtonFred Hutchinson Cancer Center, Seattle
University of Washington Medical Center- Montlake, Seattle
Virginia Mason Medical Center, Seattle

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.