Recruiting

Phase 1

Phase 2

PF-08634404 & IpilimumabSymbiotic-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

Code:

NCT07227012

Conditions

Carcinoma, Hepatocellular

Hepatocellular Cancer

Hepatocellular Carcinoma

Unresectable Hepatocellular Carcinoma

Liver Neoplasms

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

PF-08634404

Ipilimumab

Study Details

Brief 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.

Conditions

Carcinoma, Hepatocellular

Hepatocellular Cancer

Hepatocellular Carcinoma

Unresectable Hepatocellular Carcinoma

Liver Neoplasms

Study ID

NCT07227012

Start date

Dec 1, 2025

Status verified date

Aug, 2026

Completion date

Oct 17, 2028

Anticipated

Primary completion date

Oct 18, 2027

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

138 participants

Anticipated

Allocation

Randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Phase 1b

Participants will be allocated to sequential dose levels of PF-08634404 and ipilimumab.

experimental: Phase 2

Participants will be randomized to receive either PF-08634404 monotherapy or PF-08634404 combined with ipilimumab.

Interventions

PF-08634404

Solution for infusion

Ipilimumab

Solution for infusion

Primary outcome measure

Number of Participants With Adverse Events [ Time Frame: Through end of study and up to approximately 24 months ]
Phase 1b: Number of participants with Dose limiting toxicities (DLT) [ Time Frame: Through 90 days after the last dose of study intervention; Approximately 24 months ]
Phase 2: Confirmed Overall Response Rate (ORR) using RECIST 1.1 as assessed by investigator [ Time Frame: Approximately 24 months ]
Phase 2: Recommended dose of PF-08634404 in combination with ipilimumab [ Time Frame: Approximately 24 months ]

Central Contacts and Locations

Central contacts

Pfizer CT.gov Call Center

1-800-718-1021 ClinicalTrials.gov_Inquiries@pfizer.com

Locations

Chao Family Comprehensive Cancer Center and Ambulatory Care

Recruiting

Irvine, California, United States, 92612

UCI Health - Irvine Infusion Pharmacy ACC

Recruiting

Irvine, California, United States, 92612

UCI Health - Irvine

Recruiting

Irvine, California, United States, 92612

Keck Hospital of USC

Recruiting

Los Angeles, California, United States, 90033

Los Angeles General Medical Center

Recruiting

Los Angeles, California, United States, 90033

USC/Norris Comprehensive Cancer Center / Investigational Drug Services

Recruiting

Los Angeles, California, United States, 90033

USC/Norris Comprehensive Cancer Center

Recruiting

Los Angeles, California, United States, 90033

UC Irvine Health - Chao Family Comprehensive Cancer Center

Recruiting

Orange, California, United States, 92868

Keck Medical Center of USC Pasadena

Recruiting

Pasadena, California, United States, 91105

Moffitt Cancer Center at Speros

Recruiting

Land O' Lakes, Florida, United States, 34638

Moffitt Cancer Center at SouthShore

Recruiting

Ruskin, Florida, United States, 33570

Moffitt Cancer Center - International Plaza

Recruiting

Tampa, Florida, United States, 33607

Moffitt Cancer Center - McKinley Campus

Recruiting

Tampa, Florida, United States, 33612

Moffitt Cancer Center

Recruiting

Tampa, Florida, United States, 33612

Moffitt McKinley Hospital

Recruiting

Tampa, Florida, United States, 33612

Moffitt Cancer Center at Wesley Chapel

Recruiting

Wesley Chapel, Florida, United States, 33544

Memorial Hospital

Recruiting

Shiloh, Illinois, United States, 62269

Siteman Cancer Center - Shiloh

Recruiting

Shiloh, Illinois, United States, 62269

Allina Health Cancer Institute - Mercy Hospital

Recruiting

Coon Rapids, Minnesota, United States, 55433

Allina Health Cancer Institute - Abbott Northwestern Hospital

Recruiting

Minneapolis, Minnesota, United States, 55407

Allina Health Cancer Institute - United Hospital

Recruiting

Saint Paul, Minnesota, United States, 55102

Siteman Cancer Center - St. Peters

Recruiting

City of Saint Peters, Missouri, United States, 63376

Siteman Cancer Center - West County

Recruiting

Creve Coeur, Missouri, United States, 63141

Siteman Cancer Center - North County

Recruiting

Florissant, Missouri, United States, 63031

Saint Luke's Cancer Institute

Recruiting

Kansas City, Missouri, United States, 64111

Saint Luke's Hospital of Kansas City

Recruiting

Kansas City, Missouri, United States, 64111

Siteman Cancer Center

Recruiting

St Louis, Missouri, United States, 63108

Barnes-Jewish Hospital

Recruiting

St Louis, Missouri, United States, 63110

Washington University School of Medicine - Siteman Cancer Center

Recruiting

St Louis, Missouri, United States, 63110

Siteman Cancer Center - South County

Recruiting

St Louis, Missouri, United States, 63129

Renown Health Medical Oncology

Recruiting

Reno, Nevada, United States, 89502

Renown Office of Clinical Research

Recruiting

Reno, Nevada, United States, 89502

Renown Regional Medical Center

Recruiting

Reno, Nevada, United States, 89502

Duke Cancer Center Cary

Recruiting

Cary, North Carolina, United States, 27518

Duke Cancer Center - Investigational Chemotherapy Service

Recruiting

Durham, North Carolina, United States, 27710

Duke Cancer Center

Recruiting

Durham, North Carolina, United States, 27710

Duke University - Main Hospital and Clinics

Recruiting

Durham, North Carolina, United States, 27710

Duke Cancer Center Raleigh

Recruiting

Raleigh, North Carolina, United States, 27609

Fred Hutchinson Cancer Center

Recruiting

Seattle, Washington, United States, 98109

University of Washington Medical Center- Montlake

Recruiting

Seattle, Washington, United States, 98195

More Information

Sponsor

Pfizer

Last update posted

Aug 17, 2026

Last verified

Aug, 2026

Keywords

Hepatocellular Carcinoma
Liver cancer
Liver Neoplasms

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Pfizer on 2026-08-17.