drugset / Trial / NCT07392892

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

NCT07392892

Phase 2/3 Recruiting 840 enrolled Pfizer
RandomizedParallel-groupDouble-blindTreatment

Summary

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.

Timeline

Start
2026-05-14
Primary completion
2031-07-22
Completion
2032-07-21

Drugs

EvaluationDrugModalityDoseRoute
Comparator Nivolumab Monoclonal antibody Intravenous
Subject PF-08634404 Unknown Intravenous