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Symbiotic-GI-16: A Study to Learn About the Study Medicine Called PF-08634404 in Combination With Chemotherapy in Gastroesophageal Cancer

StatusRecruiting
PhasePhase 2/3
SponsorPfizer
Started2026-05-14
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 5 months later Jul 22, 2031 → Jan 15, 2032
See other at-risk trials from Pfizer

Amendment history

2026-09-29
notable
Trial sites expanded: 74 → 100 locations
Primary completion pushed: 2031-07-22 → 2032-01-15
Completion pushed: 2032-07-21 → 2033-01-14
2026-08-14
minor
Study Status, Contacts/Locations v5
Trial sites expanded: 70 → 74 locations
2026-07-28
minor
Study Status, Contacts/Locations v4
Study sites69→70
2026-07-23
minor
Study Status, Contacts/Locations v3
Study sites71→69
2026-06-10
minor
Study Identification, Study Status, Contacts/Locations v2
Trial sites expanded: 58 → 71 locations
Start dateestimated 2026-04-28→confirmed 2026-05-14
Study title+17 characters
Symbiotic-GI-16: A Study to Learn About the Study Medicine Called PF-08634404 in Combination With Chemotherapy in Gastroesophageal Cancer
2026-04-08
notable
Study Status, Eligibility, Contacts/Locations, References v1
Recruitment opened
Trial sites expanded: 0 → 58 locations
Start date2026-03-02→2026-04-28
Eligibility criteria+90 characters
[...] static disease. Adequate hepatic, liver, and renal function HER-2 negative status based on local testing PD-L1 positive status based on local testing Exclusion Criteria: Participants with known active CNS metas [...]
2026-01-30
minor
Original filing
431 trials monitored
See 32 trials at risk
1,194 trials monitored
See 60 trials at risk
1,010 trials monitored
See 51 trials at risk
This study is being done to learn more about a new medicine called PF-08634404 and how well it works when given with chemotherapy to people with gastroesophageal cancer that is locally advanced (spread to nearby tissues) or has spread to other parts of the body. To join the study, participants must meet the following conditions: Be 18 years or older. Have locally advanced or metastatic gastric, gastroesophageal junction or esophageal adenocarcinoma Be treatment naïve for advanced or metastatic disease Be in good physical condition and have healthy organs based on medical tests. The study has two parts: * In the first part, researchers will check how safe the study medicine in combination with chemotherapy is and how well people respond to it. * In the second part, they will compare study medicine plus chemotherapy to another approved treatment (nivolumab plus chemotherapy) to see which works better. The treatment will be given in repeated time periods called cycles.
Trial Details
NCT Number NCT07392892
Lead Sponsor Pfizer
Conditions Untreated Advanced or Metastatic Gastric, Gastroesophageal Junction , or Esophageal Adenocarcinoma, Metastatic Gastric Cancer, Gastroesophageal Junction Cancer, Esophageal Adenocarcinoma
Enrollment 840 participants
Start Date 2026-05-14
Primary Completion 2032-01-15 (estimated)
Study Completion 2033-01-14 (estimated)
Updated on ClinicalTrials.gov 2026-09-28