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NCT Number: 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.

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Aichi Cancer Center, Nagoya, Aichi-ken, Japan

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

PF-08634404

Biological

Solution for infusion

Ipilimumab

Biological

Solution for infusion

Other names: YERVOY

Primary outcomes

  1. Number of Participants With Adverse Events

    Time frame: Through 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.

  2. 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

    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.

  3. Phase 2: Confirmed Overall Response Rate (ORR) using RECIST 1.1 as assessed by investigator

    Time frame: Approximately 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.

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

    Time frame: Approximately 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.

Secondary outcomes

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

    Time frame: Approximately 24 months

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

  2. Duration of Response (DOR) per RECIST 1.1 by investigator

    Time frame: Approximately 24 months

    DOR is the time from the first documentation of objective response (CR or PR that is subsequently confirmed) to the date of first documented disease progression per RECIST 1.1 as assessed by investigator, or death due to any cause, whichever occurs first.

  3. Progression Free Survival (PFS) per RECIST 1.1 by investigator

    Time frame: Approximately 24 months

    PFS is defined as the time from the date of first dose to the date of first documented disease progression per RECIST 1.1 as assessed by investigator, or death due to any cause, whichever occurs first.

  4. Overall Survival (OS)

    Time frame: Approximately 24 months

    OS is defined as the time from the date of first dose to the date of death due to any cause.

  5. 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)

    Laboratory abnormalities as characterized by type, frequency, severity (as graded by NCI CTCAE version 5.0), and timing

  6. Pharmacokinetics (PK): Serum concentrations of PF-08634404

    Time frame: Up to 24 months

    Predose and/or postdose concentrations of PF-08634404 in combination with ipilimumab.

  7. Incidence of antidrug antibody against PF-08634404

    Time frame: Up to 24 months

    To evaluate immunogenicity of PF-08634404 in combination with ipilimumab.

Study contacts

Contact information is provided by the study sponsor or research team.

Pfizer CT.gov Call Center

CONTACT

[email protected]

1-800-718-1021

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Nov 12, 2025
Registry last updated
Jul 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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