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

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 482 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. This study also contains two substudies: 1) 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 and 2) a substudy intended to test the efficacy of bezuclastinib and sunitinib as first-line treatment of GIST in approximately 40 participants with KIT exon 9 mutations and no prior systemic therapy (with the exception of up to 10 subjects with ongoing imatinib therapy of ≤4 weeks).

Conditions

• Advanced Gastrointestinal Stromal Tumors
• Metastatic Cancer

Interventions

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.

DRUG

CGT9486 plus sunitinib

Participants will receive both CGT9486 and sunitinib orally until study stopping rules are met.

Sponsors & Collaborators

• Cogent Biosciences, Inc.

  lead INDUSTRY

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-04-14

Primary Completion

2025-09-30

Completion

2030-01-31

FDA Drug

Yes

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

Study Locations