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.

Part of paid clinical trials in Land O' Lakes, Florida.

Sponsor
Pfizer
Study ID
NCT07227012
Phase
PHASE1/PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

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

Locations (22)

FacilityCityStateZIPSite coordinators
Moffitt Cancer Center at SperosLand O' LakesFlorida34638-
Moffitt Cancer Center at SouthShoreRuskinFlorida33570-
Moffitt Cancer CenterTampaFlorida33612-
Moffitt Cancer Center - International PlazaTampaFlorida33607-
Moffitt Cancer Center - McKinley CampusTampaFlorida33612-
Moffitt McKinley HospitalTampaFlorida33612-
Moffitt Cancer Center at Wesley ChapelWesley ChapelFlorida33544-
Memorial HospitalShilohIllinois62269-
Siteman Cancer Center - ShilohShilohIllinois62269-
Allina Health Cancer Institute - Mercy HospitalCoon RapidsMinnesota55433-
Allina Health Cancer Institute - Abbott Northwestern HospitalMinneapolisMinnesota55407-
Allina Health Cancer Institute - United HospitalSaint PaulMinnesota55102-
Siteman Cancer Center - St. PetersCity of Saint PetersMissouri63376-
Siteman Cancer Center - West CountyCreve CoeurMissouri63141-
Siteman Cancer Center - North CountyFlorissantMissouri63031-
Barnes-Jewish HospitalSt LouisMissouri63110-
Siteman Cancer CenterSt LouisMissouri63108-
Siteman Cancer Center - South CountySt LouisMissouri63129-
Washington University School of Medicine - Siteman Cancer CenterSt LouisMissouri63110-
Renown Health Medical OncologyRenoNevada89502-
Renown Office of Clinical ResearchRenoNevada89502-
Renown Regional Medical CenterRenoNevada89502-

Find similar trials in Land O' Lakes, FL

By condition
Liver cancer
By specialty
OncologyGI oncologyHepatology
By research site
Moffitt Cancer Center at Speros· Land O' Lakes, FLMoffitt Cancer Center at SouthShore· Ruskin, FLMoffitt Cancer Center· Tampa, FLMoffitt Cancer Center - International Plaza· Tampa, FLMoffitt Cancer Center - McKinley Campus· Tampa, FLMoffitt McKinley Hospital· Tampa, FL

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