Participate in Research at CU Anschutz

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.

This study plans to learn more about an investigational drug called bezuclastinib (also known as CGT9486) in combination with sunitinib. “Investigational” means that the study drug has not been approved by the U.S. Food and Drug Administration (FDA). The purpose of this part of the research study is to evaluate how bezuclastinib plus sunitinib affects your gastrointestinal stromal tumors (GIST) compared to treatment with sunitinib alone. You are being asked to be in this research study because you have advanced GIST and your previous therapy was either no longer effective or not tolerated.