Trial 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
- Phase
- Phase 3
- Sponsor
- Pfizer
- Conditions
- Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Colorectal Neoplasms
- Ages
- 18+ years
Eligibility criteria
Highlighted: restrictions our model extracted, each a verbatim quote (pink = excludes outright, blue = only under conditions).
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) 0-1Performance status
* 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 compressionBrain metastases
* 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
Restrictions found (2)
- Brain metastasesConditionalexclusionShow in the text
- Performance statusOutrightinclusion
ECOG 0-1
Show in the text
Recruiting in Massachusetts
- Brigham and Women's Hospital (BWH) · Boston, Suffolk County
- Dana-Farber Cancer Institute (DFCI) · Boston, Suffolk County
- Dana-Farber Brigham Cancer Center - Foxborough · Foxborough, Norfolk County
- Dana-Farber Brigham Cancer Center at Milford Regional Medical Center · Milford, Worcester County
- Dana-Farber Cancer Institute -Chestnut Hill · Newton, Middlesex County