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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
View on ClinicalTrials.gov ↗

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)

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