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.

Conditions

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

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• PF-08634404 — BIOLOGICAL
  Solution for infusion
• Ipilimumab — BIOLOGICAL
  Solution for infusion

Study Details

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.

Key Dates

First listed

Nov 12, 2025

Start date

Dec 1, 2025

Status verified

Jun 2026

Primary completion

Oct 18, 2027

Completion

Oct 17, 2028

Study Design

Enrollment

138 participants (estimated)

Allocation

RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Arms

• Experimental: Phase 1b
  Participants will be allocated to sequential dose levels of PF-08634404 and ipilimumab.
• Experimental: Phase 2
  Participants will be randomized to receive either PF-08634404 monotherapy or PF-08634404 combined with ipilimumab.

Primary Outcome Measure

Number of Participants With Adverse Events [ Time Frame: Through end of study and up to approximately 24 months ]

Central Contacts

• Pfizer CT.gov Call Center
  1-800-718-1021
  [email protected]

Locations (29)

Find similar trials in Los Angeles, CA

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