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PF-08634404 with Chemotherapy for Metastatic Colorectal Cancer

This study, called Symbiotic-GI-03, is looking into a new treatment for metastatic colorectal cancer (cancer that has spread). It's testing a medicine called PF-08634404 in combination with standard chemotherapy and bevacizumab. The goal is to see if this combination can help people whose colorectal cancer has spread. To join, you must be at least 18 years old, have colorectal cancer that has spread, and be well enough for treatment. The study will measure how long people live and how long they live without their cancer getting worse, over about 4 years. You will be randomly assigned to one of two treatment groups.

Study design
This is an interventional study planning to enroll 800 participants. You will be randomly assigned to one of two different treatment arms, like flipping a coin.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The study will measure how long you live and how long you live without your cancer getting worse for approximately 4 years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07222800

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

Recruiting
PHASE3Ages 18+InterventionalTreatment
Pfizer
~800 participants
Updated 2026-08-17 on ClinicalTrials.gov
What's tested:PF-08634404BevacizumabChemotherapy

At a glance

Recruiting sites
291 of 308 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1) by Blinded Independent Central Review (BICR)
Measured over Approximately 4 years
+1 more outcome measured

Conditions

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

Explore related trials

Colorectal Carcinoma

Where it's being run

308 sites across 89 states
Texas29
Florida22
Colorado17
New York15
Virginia15
California14
Illinois12
Arizona11

Study leadership

  • Pfizer CT.gov Call Center · STUDY_DIRECTOR · Pfizer

Who to contact

Pfizer CT.gov Call Center
[email protected]
1-800-718-1021
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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 trial measures

  • Progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1) by Blinded Independent Central Review (BICR)Approximately 4 years

    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 BICR per RECIST 1.1, or death due to any cause, whichever occurs first.

  • Overall survival (OS)Approximately 4 years

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