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Clinical Trial 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 426 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 at least one prior line of therapy for GIST and 2) evaluating for drug-drug interactions between CGT9486 and sunitinib in approximately 18 patients who have received at least two prior tyrosine kinase inhibitors (TKIs) for GISTs. The second part of the study will enroll approximately 388 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.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT05208047
Study type Interventional
Source Cogent Biosciences, Inc.
Contact Shaun Mitchell
Phone 973-220-4291
Email [email protected]
Status Recruiting
Phase Phase 3
Start date April 14, 2022
Completion date September 2026

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