RecruitingPhase 3NCT07222800

Symbiotic-GI-03: A Study to Learn About the Study Medicine Called PF-08634404 in Combination With Chemotherapy in Adult Participants With Metastatic Colorectal Cancer

AN INTERVENTIONAL, PHASE 3, DOUBLE-BLIND, RANDOMIZED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF PF-08634404 IN COMBINATION WITH CHEMOTHERAPY VERSUS BEVACIZUMAB IN COMBINATION WITH CHEMOTHERAPY IN TREATMENT-NAÏVE PARTICIPANTS WITH METASTATIC COLORECTAL CANCER

Sponsor

Pfizer

Enrollment

800 participants

Start Date

Dec 11, 2025

Study Type

INTERVENTIONAL

Conditions

Colorectal Neoplasms Neoplasms by Site Gastrointestinal Neoplasms Intestinal Neoplasms Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Rectal Diseases Digestive System Neoplasms

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new drug called PF-08634404 in combination with standard chemotherapy for adults with colorectal cancer that has spread to other parts of the body (metastatic, or Stage IV). The goal is to find out whether adding this new drug improves outcomes compared to chemotherapy alone. **You may be eligible if...** - You are an adult with colorectal cancer confirmed by biopsy or lab test - Your cancer has spread beyond the colon or rectum (Stage IV) - You have not yet received any treatment specifically for your metastatic disease - You are in good physical condition and able to carry out daily activities (ECOG score of 0 or 1) - You have at least one measurable tumor that can be tracked on scans **You may NOT be eligible if...** - Your tumor has a specific genetic change called BRAF V600E mutation - Your cancer has a feature called microsatellite instability-high (MSI-H) or mismatch repair deficiency (dMMR) - You have active cancer spread to the brain or spinal cord - You have had major surgery or serious bleeding in the past 4 weeks - You have significant heart disease, autoimmune disease requiring treatment, or lung inflammation Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPF-08634404

Solution for infusion

BIOLOGICALBevacizumab

Injection for intravenous use

DRUGChemotherapy

Injection for intravenous use