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Actively Recruiting

Phase 3
Age: 18Years +
All Genders
ID05208047

Phase 3 Study Comparing CGT9486 Plus Sunitinib Versus Sunitinib Alone for Advanced or Metastatic Gastrointestinal Stromal Tumors

Led by Cogent Biosciences, Inc. · Updated on 2026-06-16

482

Participants Needed

126

Research Sites

222 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating the combination of CGT9486 and sunitinib compared to sunitinib alone in patients with locally advanced, unresectable, or metastatic Gastrointestinal Stromal Tumors GIST. This Phase 3, open-label international trial involves multiple parts, including dose confirmation, drug interaction assessments, and efficacy comparisons. The study also includes substudies focusing on drug-drug interaction potential and first-line treatment in patients with specific genetic mutations KIT exon 9. Approximately 482 patients will participate across these parts.

CONDITIONS

Brief Title

(Peak) A Phase 3 Randomized Trial of CGT9486+Sunitinib vs. Sunitinib in Subjects With Gastrointestinal Stromal Tumors

Research Team

C

Cogent Biosciences

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