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Carcinoma, HepatocellularPhase 1/2NCT07227012

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.

A Phase 1/2 study testing PF-08634404 and Ipilimumab in people with Carcinoma, Hepatocellular and Hepatocellular Cancer, run by Pfizer at 60 sites in 5 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
PF-08634404 and Ipilimumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
138 participants
Where
60 sitesin 5 countries
Study dates
1 Dec 2025to 17 Oct 2028
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.
Show all 13Show fewer
  • 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.

Trial locations and contacts

60 sites in 5 countries. Contact the study team or a site near you to ask about taking part.

Pfizer CT.gov Call Center contact

1-800-718-1021

ClinicalTrials.gov_Inquiries@pfizer.com

60 sites in 5 countries

United States46 sites, 46 recruiting

  • Duke Cancer Center Cary

    Cary, North Carolina, 27518

    Recruiting

  • Siteman Cancer Center - St. Peters

    City of Saint Peters, Missouri, 63376

    Recruiting

  • University Hospitals Cleveland Medical Center

    Cleveland, Ohio, 44106

    Recruiting

  • Allina Health Cancer Institute - Mercy Hospital

    Coon Rapids, Minnesota, 55433

    Recruiting

  • Siteman Cancer Center - West County

    Creve Coeur, Missouri, 63141

    Recruiting

  • Duke Cancer Center - Investigational Chemotherapy Service

    Durham, North Carolina, 27710

    Recruiting

  • Duke Cancer Center

    Durham, North Carolina, 27710

    Recruiting

  • Duke University - Main Hospital and Clinics

    Durham, North Carolina, 27710

    Recruiting

  • Siteman Cancer Center - North County

    Florissant, Missouri, 63031

    Recruiting

  • Chao Family Comprehensive Cancer Center and Ambulatory Care

    Irvine, California, 92612

    Recruiting

  • UCI Health - Irvine Infusion Pharmacy ACC

    Irvine, California, 92612

    Recruiting

  • UCI Health - Irvine

    Irvine, California, 92612

    Recruiting

  • Saint Luke's Cancer Institute

    Kansas City, Missouri, 64111

    Recruiting

  • Saint Luke's Hospital of Kansas City

    Kansas City, Missouri, 64111

    Recruiting

  • Moffitt Cancer Center at Speros

    Land O' Lakes, Florida, 34638

    Recruiting

  • START Los Angeles, LLC

    Los Angeles, California, 90025

    Recruiting

  • Keck Hospital of USC

    Los Angeles, California, 90033

    Recruiting

  • Los Angeles General Medical Center

    Los Angeles, California, 90033

    Recruiting

  • USC/Norris Comprehensive Cancer Center / Investigational Drug Services

    Los Angeles, California, 90033

    Recruiting

  • USC/Norris Comprehensive Cancer Center

    Los Angeles, California, 90033

    Recruiting

  • LACN Century City

    Los Angeles, California, 90067

    Recruiting

  • Allina Health Cancer Institute - Abbott Northwestern Hospital

    Minneapolis, Minnesota, 55407

    Recruiting

  • UC Irvine Health - Chao Family Comprehensive Cancer Center

    Orange, California, 92868

    Recruiting

  • Keck Medical Center of USC Pasadena

    Pasadena, California, 91105

    Recruiting

  • AHN Allegheny General Hospital

    Pittsburgh, Pennsylvania, 15212

    Recruiting

  • AHN Cancer Institute at Allegheny General Hospital

    Pittsburgh, Pennsylvania, 15212

    Recruiting

  • Duke Cancer Center Raleigh

    Raleigh, North Carolina, 27609

    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

  • Moffitt Cancer Center at SouthShore

    Ruskin, Florida, 33570

    Recruiting

  • Allina Health Cancer Institute - United Hospital

    Saint Paul, Minnesota, 55102

    Recruiting

  • Virginia Mason Medical Center

    Seattle, Washington, 98101

    Recruiting

  • Fred Hutchinson Cancer Center

    Seattle, Washington, 98109

    Recruiting

  • University of Washington Medical Center- Montlake

    Seattle, Washington, 98195

    Recruiting

  • Memorial Hospital

    Shiloh, Illinois, 62269

    Recruiting

  • Siteman Cancer Center - Shiloh

    Shiloh, Illinois, 62269

    Recruiting

  • Siteman Cancer Center

    St Louis, Missouri, 63108

    Recruiting

  • Barnes-Jewish Hospital

    St Louis, Missouri, 63110

    Recruiting

  • Washington University School of Medicine - Siteman Cancer Center

    St Louis, Missouri, 63110

    Recruiting

  • Siteman Cancer Center - South County

    St Louis, Missouri, 63129

    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

Other trials in United States

Japan5 sites, 5 recruiting

  • National Cancer Center Hospital

    Chuo-ku, Tokyo, 104-0045

    Recruiting

  • National Hospital Organization Kyushu Cancer Center

    Fukuoka, 811-1395

    Recruiting

  • National Cancer Center Hospital East

    Kashiwa, Chiba, 277-8577

    Recruiting

  • Aichi Cancer Center

    Nagoya, Aichi-ken, 464-8681

    Recruiting

  • Kindai University Hospital- Osaka Medical Campus

    Sakai, Osaka, 590-0197

    Recruiting

Other trials in Japan

Puerto Rico4 sites, 4 recruiting

  • Pan American Center for Oncology Trials, LLC - Dorado Office

    Dorado, United States of America, 00646

    Recruiting

  • Pan American Center for Oncology Trials, LLC - Mayaguez Office

    Mayagüez, United States of America, 00680

    Recruiting

  • Pan American Center for Oncology Trials, LLC - Ponce Office

    Ponce, United States of America, 00730

    Recruiting

  • Pan American Center for Oncology Trials, LLC

    San Juan, 00909

    Recruiting

Other trials in Puerto Rico

Taiwan4 sites, 4 recruiting

  • Taichung Veterans General Hospital

    Taichung, 407

    Recruiting

  • National Cheng Kung University Hospital

    Tainan, 704

    Recruiting

  • National Taiwan University Hospital

    Taipei, 10002

    Recruiting

  • Taipei Veterans General Hospital

    Taipei, 112

    Recruiting

Other trials in Taiwan

China1 site, 1 recruiting

  • Zhongshan Hospital,Fudan University

    Shanghai, Shanghai Municipality, 200032

    Recruiting

Other trials in China

About this study

Official 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

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:

Read more
  • 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.

Being tested
PF-08634404, Ipilimumab
Keywords
Hepatocellular Carcinoma, Liver cancer, Liver Neoplasms
Medical subject headings
Carcinoma, Hepatocellular, Liver Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PF-08634404Biological

    Solution for infusion

  • IpilimumabBiological

    Also called YERVOY

    Solution for infusion

Study groups in NCT07227012
Study groupRoleWhat they receive
Phase 1bExperimentalParticipants will be allocated to sequential dose levels of PF-08634404 and ipilimumab.
Receives: Biological: PF-08634404; Biological: Ipilimumab
Phase 2ExperimentalParticipants will be randomized to receive either PF-08634404 monotherapy or PF-08634404 combined with ipilimumab.
Receives: Biological: PF-08634404; Biological: Ipilimumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Through end of study and up to approximately 24 months

  2. 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.

    Measured: Through 90 days after the last dose of study intervention; Approximately 24 months

  3. 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.

    Measured: Approximately 24 months

  4. 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.

    Measured: Approximately 24 months

Secondary outcomes (7)

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

    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.

    Measured: Approximately 24 months

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

    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.

    Measured: Approximately 24 months

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

    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.

    Measured: Approximately 24 months

  4. Overall Survival (OS)

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

    Measured: Approximately 24 months

  5. Number of Participants With Clinical Laboratory Abnormalities

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

    Measured: 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)

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

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

    Measured: Up to 24 months

  7. Incidence of antidrug antibody against PF-08634404

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

    Measured: Up to 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Nov 2025
  2. Study start1 Dec 2025
  3. Primary completion18 Oct 2027 (estimated)
  4. Study completion17 Oct 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
138 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07227012
Sponsor's protocol ID
C6461013
Other IDs
2025-523525-17-00, Symbiotic-GI-13, 2025
Status last verified
Oct 2026
First submitted
7 Nov 2025
Last updated
8 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No: 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.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing PF-08634404 and Ipilimumab in people with Carcinoma, Hepatocellular and Hepatocellular Cancer, run by Pfizer at 60 sites in 5 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 8 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 60 sites in United States, Japan, Puerto Rico, Taiwan, China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Pfizer CT.gov Call Center (1-800-718-1021, ClinicalTrials.gov_Inquiries@pfizer.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Adverse Events (time frame: Through end of study and up to approximately 24 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07227012.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2026.

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