Status:
NOT_YET_RECRUITING
A Study to Learn About the Study Medicine Called PF-08634404 in Combination With Chemotherapy in Adult Participants With Metastatic Colorectal Cancer
Lead Sponsor:
Pfizer
Conditions:
Intestinal Neoplasms
Gastrointestinal Neoplasms
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 stud...
Eligibility Criteria
Inclusion
- Histological or cytological confirmed colorectal adenocarcinoma.
- Evidence of Stage IV 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
- 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
Key Trial Info
Start Date :
December 12 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2031
Estimated Enrollment :
800 Patients enrolled
Trial Details
Trial ID
NCT07222800
Start Date
December 12 2025
End Date
August 1 2031
Last Update
October 30 2025
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