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Taking people in Puerto RicoPhase 1/2

Tests PF-08634404 alone or with ipilimumab for advanced liver cancer

Tests PF-08634404, alone or with ipilimumab, in adults with advanced liver cancer.

Key facts

Who runs it
Pfizer
Where
Dorado, Mayagüez, Ponce, and San Juan, Puerto RicoSee the 4 sitesAlso in 8 other countries, 76 sites
Registry title
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.
Status
Recruiting
Phase
Phase 1/2
People taking part
138 people, planned
Started
1 Dec 2025
Expected to end
17 Oct 2028
Type of study
Interventional, 2 groups
Treatments tested
  • PF-08634404
  • Ipilimumab
Record updated
8 October 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with liver cancer (hepatocellular carcinoma) that has spread locally or to other parts of the body and cannot be treated by surgery, and who have had no whole-body treatment yet.

Age
18 years or older
Sex
All sexes
Disease stage
Locally advanced or metastatic hepatocellular carcinoma that cannot be treated by surgery or local therapies, or has worsened after them. At least 1 measurable, untreated lesion. Child-Pugh Class A. ECOG performance status 0 or 1.
Earlier treatment
No earlier whole-body (systemic) treatment for hepatocellular carcinoma.

Main reasons for not taking part

  • Moderate or severe ascites, or a history of hepatic encephalopathy
  • Active brain or spinal cord lesions, including leptomeningeal metastasis
  • Another cancer within the last 3 years
  • Earlier organ or stem cell transplant from a donor
  • Active autoimmune disease needing whole-body treatment in the past 2 years

The registry criteria, word for word

Show all 21 criteriaShow less

Who can take part

  • 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 take part

  • 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 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
  • History of hepatic encephalopathy
  • 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
  • History of severe bleeding tendency or coagulation dysfunction
  • Participants with acute, chronic or symptomatic infections
  • Participants with history of immunodeficiency
  • Moderate or severe ascites
  • Participants with known active CNS lesions, including leptomeningeal metastasis, brainstem, meningeal, or spinal cord metastases or compression

Where in Puerto Rico

Also in 8 other countries, 76 sites

  • Pan American Center for Oncology Trials, LLC- Dorado OfficeDorado, Puerto RicoTaking people
  • Pan American Center for Oncology Trials, LLC - Mayaguez OfficeMayagüez, Puerto RicoTaking people
  • Pan American Center for Oncology Trials, LLC - Ponce OfficePonce, Puerto RicoTaking people
  • Pan American Center for Oncology Trials LLCSan Juan, Puerto RicoTaking people

About the trial

What the trial wants to find out

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.

Read full original descriptionShow less

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.

The 2 groups in the trial

  • Phase 1bTreatment being tested

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

    Treatment: PF-08634404 and Ipilimumab

  • Phase 2Treatment being tested

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

    Treatment: PF-08634404 and Ipilimumab

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
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
Plain-language title
Tests PF-08634404 alone or with ipilimumab for advanced liver cancerGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
8 October 2026