Back to search results

Study of PF-08634404 for Advanced Liver Cancer

This study is looking into a new treatment called PF-08634404, given alone or with another medicine called ipilimumab, for adults with a type of liver cancer called hepatocellular carcinoma (HCC). This is for HCC that is too advanced for surgery or has spread to other parts of the body. The main goals are to see how safe the treatments are and how well they shrink the cancer. You might be able to join if you are 18 or older, have advanced HCC, and haven't had other whole-body treatments for it. The study plans to include about 138 participants.

Study design
This is an interventional study, meaning participants will receive specific treatments. It will involve approximately 138 participants.
What's involved
Participants will receive PF-08634404, either alone or with ipilimumab, through intravenous (IV) infusions directly into a vein.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for adverse events through the end of the study and up to approximately 24 months. Dose-limiting toxicities will be measured through 90 days after the last dose of study intervention.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07227012

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.

Recruiting
PHASE1Ages 18+InterventionalTreatment
Pfizer
~138 participants
Updated 2026-08-17 on ClinicalTrials.gov
What's tested:PF-08634404Ipilimumab

At a glance

Recruiting sites
53 of 54 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of Participants With Adverse Events
Measured over Through end of study and up to approximately 24 months
+3 more outcomes measured

Conditions

Carcinoma, Hepatocellular
Hepatocellular Cancer
Hepatocellular Carcinoma
Unresectable Hepatocellular Carcinoma
Liver Neoplasms
Advanced Hepatocellular Carcinoma
Metastatic Hepatocellular Carcinoma

Explore related trials

Hepatocellular Carcinoma

NCT07227012

Where you'd take part

This study runs at 54 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Aichi Cancer Center

    Nagoya, Aichi-ken, Japanno site contact published

    Recruiting

  • Allina Health Cancer Institute - Abbott Northwestern Hospital

    Minneapolis, Minnesotano site contact published

    Recruiting

  • Allina Health Cancer Institute - Mercy Hospital

    Coon Rapids, Minnesotano site contact published

    Recruiting

  • Allina Health Cancer Institute - United Hospital

    Saint Paul, Minnesotano site contact published

    Recruiting

  • Barnes-Jewish Hospital

    St Louis, Missourino site contact published

    Recruiting

  • Chao Family Comprehensive Cancer Center and Ambulatory Care

    Irvine, Californiano site contact published

    Recruiting

  • Duke Cancer Center

    Durham, North Carolinano site contact published

    Recruiting

  • Duke Cancer Center - Investigational Chemotherapy Service

    Durham, North Carolinano site contact published

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Pfizer CT.gov Call Center · STUDY_DIRECTOR · Pfizer

Who to contact

Pfizer CT.gov Call Center
[email protected]
1-800-718-1021
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Want this trial checked against your situation?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

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

Exclusion

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 trial measures

  • Number of Participants With Adverse EventsThrough end of study and up to approximately 24 months

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

  • Phase 1b: Number of participants with Dose limiting toxicities (DLT)Through 90 days after the last dose of study intervention; Approximately 24 months

    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.

  • Phase 2: Confirmed Overall Response Rate (ORR) using RECIST 1.1 as assessed by investigatorApproximately 24 months

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

  • Phase 2: Recommended dose of PF-08634404 in combination with ipilimumabApproximately 24 months

    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.