NCT07222800From ClinicalTrials.govRecruiting

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

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

At a glance

Phase: Phase 3
Study type: Interventional
Sponsor: Pfizer
Enrolment target: 800
Started: 11 December 2025
Main results due: 23 February 2030
Study sites: 348
Registry updated: 28 September 2026

Can you take part?

Aged 18 years and over.
Open to any sex.
You need the condition being studied — healthy volunteers are not accepted.

These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.

Read the full eligibility criteria

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 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 repair deficiency (dMMR) colorectal cancer
* Participants with known active symptomatic CNS lesions, including leptomeningeal metastasis, 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 planned major surgery during the study
* History of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation
* Any Grade ≥3 bleeding/hemorrhage events within 28 days of Cycle 1 Day 1, or prior history of clinically significant bleeding events
* Clinically significant cardiovascular disease, or other comorbidities, within 6 months prior to first dose
* Participants with active autoimmune diseases requiring systemic treatment within the past 2 years
* Evidence of non-infectious or drug-induced interstitial lung disease (ILD) pneumonitis

What this study is about

In the sponsor’s own words, from the registry.

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.

Study sites(348)

Ironwood Cancer & Research Centers
Chandler, Arizona, United States
Recruiting
Banner MD Anderson Cancer Center
Gilbert, Arizona, United States
Not yet recruiting
Ironwood Cancer & Research Centers
Gilbert, Arizona, United States
Recruiting
Ironwood Cancer & Research Centers
Glendale, Arizona, United States
Recruiting
Ironwood Cancer & Research Centers
Goodyear, Arizona, United States
Recruiting
Ironwood Cancer & Research Centers
Mesa, Arizona, United States
Recruiting
Ironwood Cancer & Research Centers
Mesa, Arizona, United States
Recruiting
Banner MD Anderson Cancer Center
Phoenix, Arizona, United States
Not yet recruiting
Ironwood Cancer & Research Centers
Phoenix, Arizona, United States
Recruiting
Mayo Clinic Building- Phoenix
Phoenix, Arizona, United States
Recruiting
Mayo Clinic Hospital
Phoenix, Arizona, United States
Recruiting
Mayo Clinic
Scottsdale, Arizona, United States
Recruiting
Ironwood Cancer & Research Centers
Scottsdale, Arizona, United States
Recruiting
Banner MD Anderson Cancer Center
Sun City, Arizona, United States
Not yet recruiting
Highlands Oncology Group
Fayetteville, Arkansas, United States
Recruiting
Highlands Oncology Group
Rogers, Arkansas, United States
Recruiting
Highlands Oncology Group
Springdale, Arkansas, United States
Recruiting
UCSF at Berkeley Outpatient Center
Berkeley, California, United States
Recruiting
Alta Bates Summit Medical Center-Herrick Campus Comprehensive Cancer Center
Berkeley, California, United States
Recruiting
UCSD Medical Center - Encinitas
Encinitas, California, United States
Recruiting
Palo Alto Medical Foundation - Fremont Center
Fremont, California, United States
Recruiting
UC San Diego Medical Center - La Jolla (Jacobs Medical Center / Thornton Pavilion)
La Jolla, California, United States
Recruiting
UC San Diego Moores Cancer Center
La Jolla, California, United States
Recruiting
UCSD Koman Family Outpatient Pavilion
La Jolla, California, United States
Recruiting
Palo Alto Medical Foundation - Palo Alto Center
Palo Alto, California, United States
Recruiting
Roseville Medical Plaza Care Center
Roseville, California, United States
Recruiting
Sutter Medical Center, Sacramento Infusion Center at Roseville
Roseville, California, United States
Recruiting
University of California, Davis Comprehensive Cancer Center
Sacramento, California, United States
Recruiting
University of California, Davis Medical Center
Sacramento, California, United States
Recruiting
UC San Diego McGrath Outpatient Pavilion - Hillcrest
San Diego, California, United States
Recruiting
UC San Diego Medical Center - Hillcrest
San Diego, California, United States
Recruiting
UC San Diego Medical Center - Rancho Bernardo
San Diego, California, United States
Recruiting
UCSF at China Basin
San Francisco, California, United States
Recruiting
UCSF at Mount Zion
San Francisco, California, United States
Recruiting
UCSF at Parnassus
San Francisco, California, United States
Recruiting
UCSF Medical Center
San Francisco, California, United States
Recruiting
Dorothy Schneider Cancer Center
San Mateo, California, United States
Recruiting
Palo Alto Medical Foundation - San Mateo Care Center
San Mateo, California, United States
Recruiting
Airway Drive Care Center
Santa Rosa, California, United States
Recruiting
Palo Alto Medical Foundation - Sunnyvale Center
Sunnyvale, California, United States
Recruiting
UCSD Medical Center - Vista
Vista, California, United States
Recruiting
Rocky Mountain Cancer Centers, LLP
Aurora, Colorado, United States
Recruiting
Rocky Mountain Cancer Centers - Boulder
Boulder, Colorado, United States
Recruiting
Rocky Mountain Cancer Centers, LLP
Centennial, Colorado, United States
Recruiting
Rocky Mountain Cancer Centers, LLP
Colorado Springs, Colorado, United States
Recruiting
Rocky Mountain Cancer Centers, LLP
Colorado Springs, Colorado, United States
Recruiting
Intermountain Health Cancer Center Saint Joseph
Denver, Colorado, United States
Recruiting
Intermountain Health Saint Joseph Hospital - Research Office
Denver, Colorado, United States
Recruiting
Intermountain Health Saint Joseph Hospital
Denver, Colorado, United States
Recruiting
Rocky Mountain Cancer Centers, LLP
Denver, Colorado, United States
Recruiting
Rocky Mountain Cancer Centers, LLP
Denver, Colorado, United States
Recruiting
Rocky Mountain Cancer Centers, LLP
Englewood, Colorado, United States
Recruiting
Banner MD Anderson Cancer Center at North Colorado Medical Center
Greeley, Colorado, United States
Not yet recruiting
Banner North Colorado Medical Center - Hospital
Greeley, Colorado, United States
Not yet recruiting
Rocky Mountain Cancer Centers, LLP
Lakewood, Colorado, United States
Recruiting
Rocky Mountain Cancer Centers, LLP
Littleton, Colorado, United States
Recruiting
Rocky Mountain Cancer Centers, LLP
Lone Tree, Colorado, United States
Recruiting
Rocky Mountain Cancer Centers, LLP
Longmont, Colorado, United States
Recruiting
Banner MD Anderson Cancer Center at North Colorado Medical Center - Loveland Campus
Loveland, Colorado, United States
Not yet recruiting
Banner North Colorado Medical Center - Loveland Campus (Hospital)
Loveland, Colorado, United States
Not yet recruiting

Showing 60 of 348 sites — filter to narrow it down. 332 of the 348 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.

Source: ClinicalTrials.gov record NCT07222800. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.

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