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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
Started
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Record History

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  1. Minor Trial sites expanded: 348 → 372 locations
  2. Minor Trial sites expanded: 308 → 348 locations Show 4 more changesShow less
    • Primary completion moved earlier from Mar 29, 2030 to Feb 23, 2030
    • Study completion date: Aug 1, 2031 to Aug 17, 2031
    • Eligibility criteria expanded, about 16 words
    • Secondary endpoints: details revised at 3 of 14 entries
  3. Minor Trial sites expanded: 285 → 308 locationsv9
  4. Minor Trial sites expanded: 259 → 285 locationsv8
  5. Minor Trial sites expanded: 228 → 259 locationsv7
  6. Minor Trial sites expanded: 156 → 228 locationsv6
  7. Minor Trial sites expanded: 115 → 156 locationsv5
  8. Minor Trial sites expanded: 16 → 115 locations
    • Study title expanded, about 1 word
    v4
  9. Minor Eligibility criteria expanded, about 7 wordsv3
  10. Notable Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 16
    • Start date changed from estimate of Dec 12, 2025 to Dec 11, 2025
    • Secondary endpoints revised (14)
    v2
  11. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
436 trials monitored
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3,394 trials monitored
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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
(from sponsor)
Intestinal Neoplasms, Gastrointestinal Neoplasms, Digestive System Neoplasms, Neoplasms by Site, Digestive System Diseases, Gastrointestinal Diseases, Colonic Diseases, Intestinal Diseases +2 more
Related terms Colonic Diseases, Colonic Neoplasms, Colorectal Neoplasms, Digestive System Diseases, Digestive System Neoplasms, Gastrointestinal Diseases, Gastrointestinal Neoplasms, Intestinal Diseases, Intestinal Neoplasms, Neoplasm Metastasis, Neoplasms by Site, Rectal Diseases
Enrollment 800 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov