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.

NCT07227012 | Recruiting Phase 1 FDA Drug

• 3 other identifiers: C64610132025-523525-17-00Symbiotic-GI-13
• Study Type: interventional
• Target: 138
• Locations: 4 countries
• Sites: 49

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

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

Keywords

Hepatocellular Carcinoma; Liver cancer; Liver Neoplasms

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  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.

  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.

  Approximately 24 months

Secondary Outcomes (7)

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

  Approximately 24 months

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

  Approximately 24 months

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

  Approximately 24 months

• Overall Survival (OS)

  Approximately 24 months

• Number of Participants With Clinical Laboratory Abnormalities

  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)

Study Arms (2)

Phase 1b

EXPERIMENTAL

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

Biological: PF-08634404; Biological: Ipilimumab

Phase 2

EXPERIMENTAL

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

Biological: PF-08634404; Biological: Ipilimumab

Interventions

PF-08634404 BIOLOGICAL

Solution for infusion

Phase 1b; Phase 2

Ipilimumab BIOLOGICAL

Solution for infusion

Also known as: YERVOY

Phase 1b; Phase 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (49)

Keck Hospital of USC

Los Angeles, California, 90033, United States

RECRUITING

Los Angeles General Medical Center

Los Angeles, California, 90033, United States

RECRUITING

USC/Norris Comprehensive Cancer Center / Investigational Drug Services

Los Angeles, California, 90033, United States

RECRUITING

USC/Norris Comprehensive Cancer Center

Los Angeles, California, 90033, United States

RECRUITING

Keck Medical Center of USC Pasadena

Pasadena, California, 91105, United States

RECRUITING

Moffitt Cancer Center at Speros

Land O' Lakes, Florida, 34638, United States

RECRUITING

Moffitt Cancer Center at SouthShore

Ruskin, Florida, 33570, United States

RECRUITING

Moffitt Cancer Center - International Plaza

Tampa, Florida, 33607, United States

RECRUITING

Moffitt Cancer Center - McKinley Campus

Tampa, Florida, 33612, United States

RECRUITING

Moffitt Cancer Center

Tampa, Florida, 33612, United States

RECRUITING

Moffitt McKinley Hospital

Tampa, Florida, 33612, United States

RECRUITING

Moffitt Cancer Center at Wesley Chapel

Wesley Chapel, Florida, 33544, United States

RECRUITING

Memorial Hospital

Shiloh, Illinois, 62269, United States

RECRUITING

Siteman Cancer Center - Shiloh

Shiloh, Illinois, 62269, United States

RECRUITING

Allina Health Cancer Institute - Mercy Hospital

Coon Rapids, Minnesota, 55433, United States

RECRUITING

Allina Health Cancer Institute - Abbott Northwestern Hospital

Minneapolis, Minnesota, 55407, United States

RECRUITING

Allina Health Cancer Institute - United Hospital

Saint Paul, Minnesota, 55102, United States

RECRUITING

Siteman Cancer Center - St. Peters

City of Saint Peters, Missouri, 63376, United States

RECRUITING

Siteman Cancer Center - West County

Creve Coeur, Missouri, 63141, United States

RECRUITING

Siteman Cancer Center - North County

Florissant, Missouri, 63031, United States

RECRUITING

Saint Luke's Cancer Institute

Kansas City, Missouri, 64111, United States

NOT YET RECRUITING

Saint Luke's Hospital of Kansas City

Kansas City, Missouri, 64111, United States

NOT YET RECRUITING

Siteman Cancer Center

St Louis, Missouri, 63108, United States

RECRUITING

Barnes-Jewish Hospital

St Louis, Missouri, 63110, United States

RECRUITING

Washington University School of Medicine - Siteman Cancer Center

St Louis, Missouri, 63110, United States

RECRUITING

Siteman Cancer Center - South County

St Louis, Missouri, 63129, United States

RECRUITING

Renown Health Medical Oncology

Reno, Nevada, 89502, United States

RECRUITING

Renown Office of Clinical Research

Reno, Nevada, 89502, United States

RECRUITING

Renown Regional Medical Center

Reno, Nevada, 89502, United States

RECRUITING

Duke Cancer Center Cary

Cary, North Carolina, 27518, United States

NOT YET RECRUITING

Duke Cancer Center - Investigational Chemotherapy Service

Durham, North Carolina, 27710, United States

NOT YET RECRUITING

Duke Cancer Center

Durham, North Carolina, 27710, United States

NOT YET RECRUITING

Duke University - Main Hospital and Clinics

Durham, North Carolina, 27710, United States

NOT YET RECRUITING

Duke Cancer Center Raleigh

Raleigh, North Carolina, 27609, United States

NOT YET RECRUITING

Virginia Mason Medical Center

Seattle, Washington, 98101, United States

NOT YET RECRUITING

Fred Hutchinson Cancer Center

Seattle, Washington, 98109, United States

RECRUITING

University of Washington Medical Center- Montlake

Seattle, Washington, 98195, United States

RECRUITING

Aichi Cancer Center

Nagoya, Aichi-ken, 464-8681, Japan

RECRUITING

National Cancer Center Hospital East

Kashiwa, Chiba, 277-8577, Japan

RECRUITING

Kindai University Hospital- Osaka Medical Campus

Sakai, Osaka, 590-0197, Japan

RECRUITING

National Hospital Organization Kyushu Cancer Center

Fukuoka, 811-1395, Japan

RECRUITING

Pan American Center for Oncology Trials, LLC - Dorado Office

Dorado, United States of America, 00646, Puerto Rico

RECRUITING

Pan American Center for Oncology Trials, LLC - Mayaguez Office

Mayagüez, United States of America, 00680, Puerto Rico

RECRUITING

Pan American Center for Oncology Trials, LLC - Ponce Office

Ponce, United States of America, 00730, Puerto Rico

RECRUITING

Pan American Center for Oncology Trials, LLC

San Juan, 00909, Puerto Rico

RECRUITING

Taichung Veterans General Hospital

Taichung, 407, Taiwan

RECRUITING

National Cheng Kung University Hospital

Tainan, 704, Taiwan

RECRUITING

National Taiwan University Hospital

Taipei, 10002, Taiwan

RECRUITING

Taipei Veterans General Hospital

Taipei, 112, Taiwan

RECRUITING

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Carcinoma, Hepatocellular; Liver Neoplasms

Interventions

Ipilimumab

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Central Study Contacts

Pfizer CT.gov Call Center

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 7, 2025
• First Posted: November 12, 2025
• Study Start: December 1, 2025
• Primary Completion (Estimated): October 18, 2027
• Study Completion (Estimated): October 17, 2028
• Last Updated: July 22, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

PR (4); US (37); JP (4); TW (4)