Sorry, you need to enable JavaScript to visit this website.
Pfizer Oncology
Loading...

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

Geo Regions

Important Notice Regarding the Scientific Information You Have Requested

You are being redirected to the scientific presentations section. The information provided here relate to investigational assets. The safety and efficacy of the unapproved assets has not been proven. 

Please acknowledge that you understand this before proceeding.

Category

Genitourinary Cancer

PD-1 x VEGF Bispecific Antibody

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

AN INTERVENTIONAL PHASE 1B/2 STUDY TO EVALUATE THE SAFETY AND EFFICACY OF PF-08634404 MONOTHERAPY AND IN COMBINATION WITH OTHER ANTICANCER AGENTS IN ADULT PARTICIPANTS WITH LOCALLY ADVANCED OR METASTATIC RENAL CELL CARCINOMA

Phase 1 /2

NCT07227415

Active enrolling

Globe

Locations

Global

QR Code

Scan the QR code

for more information at clinicaltrials.gov

Share to an HCP Go to Patient Site Contact Us
Study design
Participant Group/Arm

EXPERIMENTAL: Cohort A

Participants will receive PF-08634404 IV.

Intervention/Treatment

BIOLOGICAL: PF-08634404

Concentrate for solution for infusion

Participant Group/Arm

EXPERIMENTAL: Cohort B

Participants will receive PF-08634404 in combination with drug 1.

Intervention/Treatment

BIOLOGICAL: PF-08634404

Concentrate for solution for infusion

DRUG: Combination 1

Combination Drug 1

Participant Group/Arm

EXPERIMENTAL: Cohort C

Participants will receive PF-08634404 IV in combination with drug 2.

Intervention/Treatment

BIOLOGICAL: PF-08634404

Concentrate for solution for infusion

DRUG: Combination 2

Combination Drug 2

Study design table for Clinical Trial
Key eligibility criteria
Inclusion criteria
  • 18 years of age or older at screening
  • Locally advanced (not amenable to curative surgery or radiation therapy) or metastatic RCC with diagnosis confirmed by histology/cytology
  • At least one measurable (as defined by the investigator) and untreated lesion
  • Adequate hematologic, hepatic, cardiac and renal function
  • No prior systemic therapy for RCC (immunotherapy after surgery is allowed if received \>12 months prior)
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
  • All International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) based risk categories.
Exclusion criteria

Participants may be excluded if they meet any of the following:

  • Known active brain lesions including leptomeningeal metastasis, brainstem, meningeal or spinal cord metastases or compression.
  • Clinically significant risk of haemorrhage or fistula
  • History of another malignancy within 3 years
  • History of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation.
  • active autoimmune diseases requiring systemic treatment within the past 2 years
  • uncontrolled cardiac and other comorbidities within 6 months prior to the first dose
  • Major surgery or severe trauma within 4 weeks before the first dose, or planned major surgery during the study
  • History of severe bleeding tendency or coagulation dysfunction
  • History of oesophageal varices, severe ulcers, gastrointestinal perforation, abdominal fistula, gastrointestinal obstruction, intra-abdominal abscess
  • Acute, chronic or symptomatic infections
  • Participants with history of immunodeficiency
Key dates
Study start date
  • December 2025
Estimated Study Completion Date
  • November 2028
Key endpoints
Primary Outcome Measures
Outcome Measure

Confirmed objective response rate (ORR) using RECIST v1.1 as assessed by investigator

Measure Description

ORR is defined as the proportion of participants in the analysis population having a best overall response (BOR) of confirmed complete response (CR) or confirmed partial response (PR) according to RECIST v1.1 as assessed by investigator.

Time Frame

Up to approximately 3 years

Outcome Measure

Number of Participants with Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)

Measure Description

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

Time Frame

Through 90 days after the last study intervention (Up to approximately 3 years)

Outcome Measure

Number of participants with dose limiting toxicity (DLT)

Measure Description

The number of participants who experienced DLTs during the DLT evaluation period in Cohort B (combination 1) and Cohort C (combination 2).

Time Frame

Though end of DLT evaluation period (Up to approximately 3 years)

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

Duration of Response (DOR) per RECIST v1.1 by investigator

Measure Description

DOR is defined as 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 v1.1 or death due to any cause, whichever occurs first.

Time Frame

Up to approximately 3 years

Outcome Measure

Progression Free Survival (PFS) per RECIST v1.1 by investigator

Measure Description

Progression-free survival is defined as the time from the date of randomization to the date of the first documentation of objective progressive disease (PD) assessed by investigator per RECIST v1.1, or death due to any cause, whichever occurs first.

Time Frame

Up to approximately 3 years

Outcome Measure

Overall Survival (OS)

Measure Description

Overall survival defined as the time from the date of randomization to the date of death due to any cause.

Time Frame

Up to approximately 3 years

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 (approximately 3 years)

Outcome Measure

Pharmacokinetics (PK): Serum concentration of PF-08634404

Measure Description

Pre-dose and post dose concentrations of PF-08634404

Time Frame

Up to 37 days after the last dose of treatment

Outcome Measure

Incidence of Anti-Drug Antibody (ADA) against PF-08634404

Measure Description

To evaluate the immunogenicity of PF-08634404

Time Frame

Up to 37 days after the last dose of treatment

Secondary Outcome Measures table for Clinical Trial
Number of participants

224

Collaborators and investigators

Sponsor: Pfizer

Collaborator: None

This information is current as of November 12th 2025.

Contact Us
Close

For more information, call or email the Pfizer Clinical Trial Contact Center:

1-800-887-7002 Email us

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. NCT07227415