A Study to Learn About the Study Medicine Called PF-08634404 in Combination With Chemotherapy in Adult Participants With Metastatic Colorectal Cancer

Last updated: January 29, 2026
Sponsor: Pfizer
Overall Status: Active - Recruiting

Phase

3

Condition

Stomach Cancer

Gastrointestinal Diseases And Disorders

Digestive System Neoplasms

Treatment

PF-08634404

Chemotherapy

Bevacizumab

Clinical Study ID

NCT07222800
C6461003
Symbiotic-GI-03
2025-523521-18-00
  • Ages > 18
  • All Genders

Study Summary

The purpose of this study is to learn more about a new medicine called PF-08634404, and how well it works in people with cancer of the colon or rectum (CRC)). The goal is to understand if the new study medicine, combined with chemotherapy that is approved for colorectal cancer, can help people whose cancer has spread or returned after treatments taken before.

To join the study, participants must meet the following conditions:

  • Be 18 years or older.

  • Have colorectal cancer that has spread to other parts of your body.

  • Be in good enough health to receive study treatment.

  • Should not be pregnant before starting treatment.

Participants will be randomized (like flipping a coin) to one of 2 different treatment arms. The first arm (Arm A) will include the new medicine PF-08634404 in combination with chemotherapy that is approved for colorectal cancer, and the second arm (Arm B) will include an approved medicine for colorectal cancer, called Bevacizumab, in combination with chemotherapy that is approved for this type of cancer. Participants and their doctors will not know which arm they are being assigned to. Participants will receive all the study medications through intravenous (IV) infusions, which means the medicine is given directly into a vein. The treatment will be given in cycles, and participants may continue receiving it if it is helping and they are not experiencing serious side effects.

The medicine will be given at a clinical site, where trained medical staff will check participants during and after each treatment.

  • The study is expected to last approximately 33 months for each participant.

  • Participants will have regular visits to the study site for treatment, health checks, and tests.

  • After stopping treatment, participants will return for a final visit about 30 to37 days later to check their health and review any side effects.

  • Follow-up will continue every 12 weeks by phone or in person or by reviewing health records to check on health status and any new treatments.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Histological or cytological confirmed colorectal adenocarcinoma.

  • Evidence of Stage IV metastatic disease.

  • No prior systemic therapy for metastatic disease.

  • Eastern Cooperative Oncology Group performance status (ECOG) 0-1

  • At least one measurable lesion according to RECIST 1.1 per Investigator assessment.

  • Adequate hepatic, liver, and renal function

Exclusion

Exclusion Criteria:

Participants are excluded from the study if any of the following criteria apply:

  • Locally confirmed BRAF V600E mutation

  • Locally confirmed microsatellite instability (MSI)-high or DNA mismatch repairdeficiency (dMMR) colorectal cancer

  • Participants with known active symptomatic CNS lesions, including leptomeningealmetastasis, brainstem, meningeal, or spinal cord metastases or compression

  • Clinically significant risk of hemorrhage or fistula

  • Major surgery or severe trauma within 4 weeks prior to the first dose, or plannedmajor surgery during the study

  • History of allogeneic organ transplantation and allogeneic hematopoietic stem celltransplantation

  • Any Grade ≥3 bleeding/hemorrhage events within 28 days of Cycle 1 Day 1, or priorhistory of clinically significant bleeding events

  • Clinically significant cardiovascular disease, or other comorbidities, within 6months prior to first dose

  • Participants with active autoimmune diseases requiring systemic treatment within thepast 2 years

  • Evidence of non-infectious or drug-induced interstitial lung disease (ILD)pneumonitis

Study Design

Total Participants: 800
Treatment Group(s): 3
Primary Treatment: PF-08634404
Phase: 3
Study Start date:
December 11, 2025
Estimated Completion Date:
August 01, 2031

Connect with a study center

  • Icon Cancer Centre Wesley

    Auchenflower 6943571, 4066
    Australia

    Active - Recruiting

  • Icon Cancer Centre Hobart

    Hobart 2163355, 7000
    Australia

    Active - Recruiting

  • Kyushu University Hospital

    Fukuoka 1863967, 812-8582
    Japan

    Active - Recruiting

  • Saitama Medical University International Medical Center

    Hidaka 6822161, 350-1298
    Japan

    Active - Recruiting

  • National Hospital Organization Osaka Medical Center

    Osaka 1853909, 540-0006
    Japan

    Active - Recruiting

  • Saitama Prefectural Cancer Center

    Saitama 6940394, 362-0806
    Japan

    Active - Recruiting

  • The Cancer Institute Hospital of JFCR

    Tokyo 1850147, 135-8550
    Japan

    Active - Recruiting

  • Pan American Center for Oncology Trials, LLC

    Rio Piedras 4829037, 00935
    Puerto Rico

    Active - Recruiting

  • Mid Florida Hematology and Oncology Center

    Orange City 4167055, Florida 4155751 32763
    United States

    Active - Recruiting

  • Cancer Care Centers of Brevard, Inc.

    Palm Bay 4167499, Florida 4155751 32901
    United States

    Active - Recruiting

  • Illinois Cancer Care

    Canton 4831990, Illinois 4896861 61520
    United States

    Active - Recruiting

  • Hope and Healing Cancer Services

    Hinsdale 4896012, Illinois 4896861 60521
    United States

    Active - Recruiting

  • Hematology Oncology Associates of Rockland

    Nyack 5129433, New York 5128638 10960
    United States

    Active - Recruiting

  • Oncology Associates of Oregon, P.C.

    Albany 5710756, Oregon 5744337 97321
    United States

    Active - Recruiting

  • Texas Oncology - West Texas

    Odessa 5527554, Texas 4736286 79761
    United States

    Active - Recruiting

  • Texas Oncology - Northeast Texas

    Tyler 4738214, Texas 4736286 75702
    United States

    Active - Recruiting

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