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.

June 3, 2026 updated by: Pfizer

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
138

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Japan
      • Fukuoka, Japan, 811-1395
        • Recruiting
        • National Hospital Organization Kyushu Cancer Center
    • Aichi-ken
      • Nagoya, Aichi-ken, Japan, 464-8681
        • Recruiting
        • Aichi Cancer Center
    • Chiba
      • Kashiwa, Chiba, Japan, 277-8577
        • Recruiting
        • National Cancer Center Hospital East
    • Osaka
      • Sakai, Osaka, Japan, 590-0197
        • Recruiting
        • Kindai University Hospital- Osaka Medical Campus
  • Puerto Rico
      • Rio Piedras, Puerto Rico, 00935
        • Recruiting
        • Pan American Center for Oncology Trials, LLC
      • San Juan, Puerto Rico, 00909
        • Recruiting
        • Pan American Center for Oncology Trials, LLC
    • United States of America
      • Dorado, United States of America, Puerto Rico, 00646
        • Recruiting
        • Pan American Center for Oncology Trials, LLC - Dorado Office
      • Mayagüez, United States of America, Puerto Rico, 00680
        • Recruiting
        • Pan American Center for Oncology Trials, LLC - Mayaguez Office
      • Ponce, United States of America, Puerto Rico, 00730
        • Recruiting
        • Pan American Center for Oncology Trials, LLC - Ponce Office
  • Taiwan
      • Taichung, Taiwan, 407
        • Not yet recruiting
        • Taichung Veterans General Hospital
      • Tainan, Taiwan, 704
        • Recruiting
        • National Cheng Kung University Hospital
      • Taipei, Taiwan, 112
        • Recruiting
        • Taipei Veterans General Hospital
      • Taipei, Taiwan, 10002
        • Not yet recruiting
        • National Taiwan University Hospital
  • United States
    • Florida
      • Land O' Lakes, Florida, United States, 34638
        • Recruiting
        • Moffitt Cancer Center at Speros
      • Ruskin, Florida, United States, 33570
        • Recruiting
        • Moffitt Cancer Center at SouthShore
      • Tampa, Florida, United States, 33612
        • Recruiting
        • Moffitt Cancer Center - McKinley Campus
      • Tampa, Florida, United States, 33612
        • Recruiting
        • Moffitt Cancer Center
      • Tampa, Florida, United States, 33612
        • Recruiting
        • Moffitt McKinley Hospital
      • Tampa, Florida, United States, 33607
        • Recruiting
        • Moffitt Cancer Center - International Plaza
      • Wesley Chapel, Florida, United States, 33544
        • Recruiting
        • Moffitt Cancer Center at Wesley Chapel
    • Illinois
      • Shiloh, Illinois, United States, 62269
        • Not yet recruiting
        • Siteman Cancer Center - Shiloh
      • Shiloh, Illinois, United States, 62269
        • Not yet recruiting
        • Memorial Hospital
    • Minnesota
      • Coon Rapids, Minnesota, United States, 55433
        • Recruiting
        • Allina Health Cancer Institute - Mercy Hospital
      • Minneapolis, Minnesota, United States, 55407
        • Recruiting
        • Allina Health Cancer Institute - Abbott Northwestern Hospital
      • Saint Paul, Minnesota, United States, 55102
        • Recruiting
        • Allina Health Cancer Institute - United Hospital
    • Missouri
      • City of Saint Peters, Missouri, United States, 63376
        • Not yet recruiting
        • Siteman Cancer Center - St. Peters
      • Creve Coeur, Missouri, United States, 63141
        • Not yet recruiting
        • Siteman Cancer Center - West County
      • Florissant, Missouri, United States, 63031
        • Not yet recruiting
        • Siteman Cancer Center - North County
      • St Louis, Missouri, United States, 63108
        • Not yet recruiting
        • Siteman Cancer Center
      • St Louis, Missouri, United States, 63110
        • Not yet recruiting
        • Barnes-Jewish Hospital
      • St Louis, Missouri, United States, 63110
        • Not yet recruiting
        • Washington University School of Medicine - Siteman Cancer Center
      • St Louis, Missouri, United States, 63129
        • Not yet recruiting
        • Siteman Cancer Center - South County
    • Nevada
      • Reno, Nevada, United States, 89502
        • Recruiting
        • Renown Regional Medical Center
      • Reno, Nevada, United States, 89502
        • Recruiting
        • Renown Health Medical Oncology
      • Reno, Nevada, United States, 89502
        • Recruiting
        • Renown Office of Clinical Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Phase 1b
Participants will be allocated to sequential dose levels of PF-08634404 and ipilimumab.
Biological: PF-08634404
Solution for infusion
Biological: Ipilimumab
Solution for infusion
Other Names:
  • YERVOY
Experimental: Phase 2
Participants will be randomized to receive either PF-08634404 monotherapy or PF-08634404 combined with ipilimumab.
Biological: PF-08634404
Solution for infusion
Biological: Ipilimumab
Solution for infusion
Other Names:
  • YERVOY

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
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
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.
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
ORR is the proportion of participants with a best overall response (BOR) of confirmed CR or confirmed PR per RECIST 1.1 by investigator.
Approximately 24 months
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.
Approximately 24 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
Approximately 24 months
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.
Approximately 24 months
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.
Approximately 24 months
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.
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)
Laboratory abnormalities as characterized by type, frequency, severity (as graded by NCI CTCAE version 5.0), and timing
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
Predose and/or postdose concentrations of PF-08634404 in combination with ipilimumab.
Up to 24 months
Incidence of antidrug antibody against PF-08634404
Time Frame: Up to 24 months
To evaluate immunogenicity of PF-08634404 in combination with ipilimumab.
Up to 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Pfizer

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Pfizer CT.gov Call Center, Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 18, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 17, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 7, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 7, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 12, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 4, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 3, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • C6461013
  • 2025-523525-17-00 (Ctis)
  • Symbiotic-GI-13 (Other Identifier: Pfizer)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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