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

• Status: Not yet recruiting
• Trial end date: 2026-09-01

Summary

This is a Phase 3, open-label, international, multicenter study of CGT9486 in combination with sunitinib. This is a multi-part study that will enroll approximately 388 patients. Part 1 consists of two evaluations: 1) confirming the dose of an updated formulation of CGT9486 to be used in subsequent parts in approximately 20 patients who have received multiple prior lines of therapy and 2) evaluating for drug-drug interactions between CGT9486 and sunitinib in approximately 18 patients who have received at least two prior lines of therapy. The second part of the study will enroll up to 350 patients who are intolerant to, or who failed prior treatment with, imatinib only and will compare the efficacy of CGT9486 plus sunitinib to sunitinib alone with patients being randomized in a 1:1 manner.

• Phase: Phase 3

Details

• Lead Sponsor: Cogent Biosciences, Inc.
• Treatments: Sunitinib