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.

Condition(s) studied

Investigational drug(s) / intervention(s)

PF-08634404: Solution for infusion

Ipilimumab: Solution for infusion

Study 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.

Eligibility

Primary outcome measure(s)

• Number of Participants With Adverse Events — Through end of study and up to approximately 24 months
  Adverse Events as characterized by type, frequency, severity (as graded by NCI CTCAE version 5.0), timing, seriousness, and relationship to study intervention.
• Phase 1b: Number of participants with Dose limiting toxicities (DLT) — Through 90 days after the last dose of study intervention; Approximately 24 months
  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.
• Phase 2: Confirmed Overall Response Rate (ORR) using RECIST 1.1 as assessed by investigator — Approximately 24 months
  ORR is the proportion of participants with a best overall response (BOR) of confirmed CR or confirmed PR per RECIST 1.1 by investigator.
• Phase 2: Recommended dose of PF-08634404 in combination with ipilimumab — Approximately 24 months
  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.

Trial sites (60)

+ 20 more sites — see the full list on the official registry below.

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