NCT05208047

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

A Phase 3 Randomized, Open-Label, Multicenter Clinical Study of CGT9486+Sunitinib vs. Sunitinib in Subjects With Locally Advanced, Unresectable, or Metastatic Gastrointestinal Stromal Tumors

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 442 (estimated)
• Sponsor: Cogent Biosciences, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 442 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 the potential 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. Additionally, a drug-drug interactions substudy will investigate the potential for CGT9486 to be a CYP3A4 inducer in approximately 16 patients who have received at least one prior line of therapy for GIST.

Conditions

• Advanced Gastrointestinal Stromal Tumors
• Metastatic Cancer

Interventions

Type	Name	Description
DRUG	CGT9486 plus sunitinib	Participants will receive both CGT9486 and sunitinib orally until study stopping rules are met.
DRUG	CGT9486	Participants will receive CGT9486 until steady state then both CGT9486 and sunitinib orally until study stopping rules are met.
DRUG	Sunitinib	Participants will receive sunitinib until steady state then both sunitinib and CGT9486 orally until study stopping rules are met.
DRUG	Sunitinib	Participants will receive sunitinib orally until study stopping rules are met.
DRUG	Midazolam	Participants will receive a single-dose of midazolam on Day 1 and Day 16
DRUG	CGT9486 plus sunitinib	Patients will receive CGT9486 orally starting on Day 2 and sunitinib starting on Day 16 until study stopping rules are met.

Timeline

• Start date: 2022-04-14
• Primary completion: 2025-09-30
• Completion: 2026-09-01
• First posted: 2022-01-26
• Last updated: 2026-02-04

Locations

110 sites across 22 countries: United States, Argentina, Australia, Brazil, Canada, Chile, Czechia, Denmark, France, Germany, Hong Kong, Hungary, Italy, Mexico, Netherlands, Norway, Poland, South Korea, Spain, Sweden, Taiwan, United Kingdom

Regulatory

• FDA-regulated drug study