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The safety and efficacy of this agent(s), or use in this setting, has not been established or is subject to confirmation. For an agent(s) whose safety and efficacy has not been established or confirmed, future regulatory approval or commercial availability is not guaranteed.

Clinical Trial Details

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Category

Gastrointestinal Cancer

PD-1 x VEGF Bispecific Antibody

PF-08634404 is an investigational compound. Its safety and efficacy have not been established.

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

Phase 1 /2

NCT07227012

Active enrolling

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Locations

Puerto Rico

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Study design
Participant Group/Arm

EXPERIMENTAL: Phase 1b

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

Intervention/Treatment

BIOLOGICAL: PF-08634404

Solution for infusion

BIOLOGICAL: Ipilimumab

Solution for infusion

Participant Group/Arm

EXPERIMENTAL: Phase 2

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

Intervention/Treatment

BIOLOGICAL: PF-08634404

Solution for infusion

BIOLOGICAL: Ipilimumab

Solution for infusion

Study design table for Clinical Trial
Key eligibility criteria
Inclusion criteria
  • 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

 

Exclusion criteria

Key Exclusion Criteria:

  • 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.
  • 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.
Key dates
Study start date
  • December 2025
Estimated Study Completion Date
  • October 2028
Key endpoints
Primary Outcome Measures
Outcome Measure

Number of Participants With Adverse Events

Measure Description

Adverse Events as characterized by type, frequency, severity (as graded by NCI CTCAE version 5.0), timing, seriousness, and relationship to study intervention.

Time Frame

Through end of study and up to approximately 24 months

Outcome Measure

Phase 1b: Number of participants with Dose limiting toxicities (DLT)

Measure Description

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.

Time Frame

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

Outcome Measure

Phase 2: Confirmed Overall Response Rate (ORR) using RECIST 1.1 as assessed by investigator

Measure Description

ORR is the proportion of participants with a best overall response (BOR) of confirmed CR or confirmed PR per RECIST 1.1 by investigator.

Time Frame

Approximately 24 months

Outcome Measure

Phase 2: Recommended dose of PF-08634404 in combination with ipilimumab

Measure Description

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.

Time Frame

Approximately 24 months

Primary Outcome Measures table for Clinical Trial
Secondary Outcome Measures:
Outcome Measure

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

Measure Description

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.

Time Frame

Approximately 24 months

Outcome Measure

Duration of Response (DOR) per RECIST 1.1 by investigator

Measure Description

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.

Time Frame

Approximately 24 months

Outcome Measure

Progression Free Survival (PFS) per RECIST 1.1 by investigator

Measure Description

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.

Time Frame

Approximately 24 months

Outcome Measure

Overall Survival (OS)

Measure Description

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

Time Frame

Approximately 24 months

Outcome Measure

Number of Participants With Clinical Laboratory Abnormalities

Measure Description

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

Time Frame

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)

Outcome Measure

Pharmacokinetics (PK): Serum concentrations of PF-08634404

Measure Description

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

Time Frame

Up to 24 months

Outcome Measure

Incidence of antidrug antibody against PF-08634404

Measure Description

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

Time Frame

Up to 24 months

Secondary Outcome Measures table for Clinical Trial
Number of participants

138

Collaborators and investigators

Sponsor: Pfizer

Collaborator: None

This information is current as of December 18th 2025.

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When calling, please reference this study number:

More Information Close NCT# stands for National Clinical Trial number. This is a unique identification code given to each clinical trial registered on ClinicalTrials.gov. The format is "NCT" followed by an 8-digit number (for example, NCT00000419). Also called the ClinicalTrials.gov identifier. NCT07227012