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RecruitingInterventionalPhase 1/Phase 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

NCT ID: NCT07227012Sponsor: PfizerLast updated: 2026-06-04

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.

Arms & interventions

  • BiologicalPF-08634404

    Solution for infusion

  • BiologicalIpilimumab

    Solution for infusion

Outcome measures

Primary

  • Number of Participants With Adverse Events

    Adverse Events as characterized by type, frequency, severity (as graded by NCI CTCAE version 5.0), timing, seriousness, and relationship to study intervention.

    Time frame: Through end of study and up to approximately 24 months

  • Phase 1b: Number of participants with Dose limiting toxicities (DLT)

    DLTs are a predefined set of adverse events that are at least possibly related to any or all of the study interventions. The number of participants who experienced DLTs during the DLT observation period.

    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

    ORR is the proportion of participants with a best overall response (BOR) of confirmed CR or confirmed PR per RECIST 1.1 by investigator.

    Time frame: Approximately 24 months

  • Phase 2: Recommended dose of PF-08634404 in combination with ipilimumab

    The doses of PF-08634404 and ipilimumab selected to be used in combination based on safety, tolerability, pharmacokinetics, and initial anti-tumor efficacy from Phase 2.

    Time frame: Approximately 24 months

Secondary

  • Phase 1b: Confirmed Objective Response Rate (ORR) using RECIST 1.1 as assessed by investigator

    Time frame: Approximately 24 months

  • Duration of Response (DOR) per RECIST 1.1 by investigator

    Time frame: Approximately 24 months

  • Progression Free Survival (PFS) per RECIST 1.1 by investigator

    Time frame: Approximately 24 months

  • Overall Survival (OS)

    Time frame: Approximately 24 months

  • Number of Participants With Clinical Laboratory Abnormalities

    Time frame: Time from the date of first dose of study intervention through 30-37 days after last dose of study intervention (assessed up to approximately 24 months)

  • Pharmacokinetics (PK): Serum concentrations of PF-08634404

    Time frame: Up to 24 months

  • Incidence of antidrug antibody against PF-08634404

    Time frame: Up to 24 months

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy volunteers: No
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 locations (22)

Moffitt Cancer Center at Speros

Land O' Lakes, Florida, 34638

Recruiting

Moffitt Cancer Center at SouthShore

Ruskin, Florida, 33570

Recruiting

Moffitt Cancer Center - International Plaza

Tampa, Florida, 33607

Recruiting

Moffitt Cancer Center - McKinley Campus

Tampa, Florida, 33612

Recruiting

Moffitt Cancer Center

Tampa, Florida, 33612

Recruiting

Moffitt McKinley Hospital

Tampa, Florida, 33612

Recruiting

Moffitt Cancer Center at Wesley Chapel

Wesley Chapel, Florida, 33544

Recruiting

Memorial Hospital

Shiloh, Illinois, 62269

Not Yet Recruiting

Siteman Cancer Center - Shiloh

Shiloh, Illinois, 62269

Not Yet Recruiting

Allina Health Cancer Institute - Mercy Hospital

Coon Rapids, Minnesota, 55433

Recruiting

Allina Health Cancer Institute - Abbott Northwestern Hospital

Minneapolis, Minnesota, 55407

Recruiting

Allina Health Cancer Institute - United Hospital

Saint Paul, Minnesota, 55102

Recruiting

Siteman Cancer Center - St. Peters

City of Saint Peters, Missouri, 63376

Not Yet Recruiting

Siteman Cancer Center - West County

Creve Coeur, Missouri, 63141

Not Yet Recruiting

Siteman Cancer Center - North County

Florissant, Missouri, 63031

Not Yet Recruiting

Siteman Cancer Center

St Louis, Missouri, 63108

Not Yet Recruiting

Barnes-Jewish Hospital

St Louis, Missouri, 63110

Not Yet Recruiting

Washington University School of Medicine - Siteman Cancer Center

St Louis, Missouri, 63110

Not Yet Recruiting

Siteman Cancer Center - South County

St Louis, Missouri, 63129

Not Yet Recruiting

Renown Health Medical Oncology

Reno, Nevada, 89502

Recruiting

Renown Office of Clinical Research

Reno, Nevada, 89502

Recruiting

Renown Regional Medical Center

Reno, Nevada, 89502

Recruiting
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. | Cancerify