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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

StatusRecruiting
PhasePhase 3
SponsorPfizer
Started2025-12-11
View on ClinicalTrials.gov ↗

Amendment history

2026-09-29
minor
Trial sites expanded: 308 → 348 locations
Primary completion moved earlier: 2030-03-29 → 2030-02-23
2026-08-14
minor
Study Status, Contacts/Locations v8
Trial sites expanded: 285 → 308 locations
2026-07-21
minor
Study Status, Contacts/Locations v7
Trial sites expanded: 259 → 285 locations
2026-07-02
minor
Study Status, Contacts/Locations v6
Trial sites expanded: 228 → 259 locations
2026-06-03
minor
Study Status, Contacts/Locations v5
Trial sites expanded: 156 → 228 locations
2026-04-20
minor
Study Status, Contacts/Locations v4
Trial sites expanded: 115 → 156 locations
2026-04-02
minor
Study Identification, Study Status, Contacts/Locations v3
Trial sites expanded: 16 → 115 locations
Study title+17 characters
Symbiotic-GI-03: A Study to Learn About the Study Medicine Called PF-08634404 [...]
2026-01-29
minor
Study Status, Eligibility v2
Eligibility criteria+50 characters
[...] al adenocarcinoma. Evidence of Stage IV metastatic disease. No prior systemic therapy for metastatic disease. Eastern Cooperative Oncology Group performance status (ECOG) [...]
2026-01-09
notable
Not Yet Recruiting→Recruiting Study Identification, Study Status, Outcome Measures, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2025-12-12→confirmed 2025-12-11
Study sites0→16
Secondary endpoints14 entries, revised
Mean scorescores and Change from baseline in the global health status/quality of [...]
2025-10-28
minor
Original filing
431 trials monitored
See 32 trials at risk
2,904 trials monitored
See 127 trials at risk
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.
Trial Details
NCT Number NCT07222800
Lead Sponsor Pfizer
Conditions Intestinal Neoplasms, Gastrointestinal Neoplasms, Digestive System Neoplasms, Neoplasms by Site, Digestive System Diseases, Gastrointestinal Diseases, Colonic Diseases, Intestinal Diseases +2 more
Enrollment 800 participants
Start Date 2025-12-11
Primary Completion 2030-02-23 (estimated)
Study Completion 2031-08-17 (estimated)
Updated on ClinicalTrials.gov 2026-09-28