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

ClinicalTrials.gov ID: NCT05208047

Public ClinicalTrials.gov record NCT05208047. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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ClinicalTrials.gov public records Last synced Sep 6, 2026, 10:11 AM EDT

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Official title

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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 Gastrointestinal Stromal Tumors (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 (DDI) substudy will investigate the potential for CGT9486 to be a Cytochrome P450 (CYP)3A4 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 (1L) 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).

Study identification

NCT ID: NCT05208047
Recruitment status: Recruiting
Study type: Interventional
Phase: Phase 3
Lead sponsor: Cogent Biosciences, Inc.; Industry
Enrollment: 482 participants

Conditions and interventions

Conditions

Interventions

CGT9486 Drug
Sunitinib Drug
Midazolam Drug

Drug

Eligibility (public fields only)

Age range: 18 Years and older
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Apr 13, 2022
Primary completion: Sep 29, 2025
Completion: Dec 31, 2029
Last update posted: Jun 15, 2026

2022 – 2030

United States locations

U.S. sites: 36
U.S. states: 23
U.S. cities: 36

Facility	City	State	ZIP	Site status
University of Alabama at Birmingham	Birmingham	Alabama	35249	Withdrawn
Mayo Clinic	Scottsdale	Arizona	85259	Active, not recruiting
University of Arizona- Cancer Center	Tucson	Arizona	85719	Active, not recruiting
City of Hope	Duarte	California	91010	Active, not recruiting
University of California, Los Angeles (UCLA)	Los Angeles	California	90404	Active, not recruiting
University of California, San Diego (UCSD)	San Diego	California	92093	Active, not recruiting
University of California, San Francisco	San Francisco	California	94158	Active, not recruiting
University of Colorado Denver	Denver	Colorado	80204	Active, not recruiting
MedStar Washington Hospital Center	Washington D.C.	District of Columbia	20010	Recruiting
Mayo Clinic Jacksonville	Jacksonville	Florida	32224	Active, not recruiting
University of Miami - Sylvester Comprehensive Cancer Center	Miami	Florida	33136	Recruiting
Mid Florida Hematology and Oncology Center	Orange City	Florida	32763	Withdrawn
Orlando Health Cancer Institute	Orlando	Florida	32806	Recruiting
Moffitt Cancer Center	Tampa	Florida	33612	Recruiting
Northwestern University	Chicago	Illinois	60611	Recruiting
University of Iowa Hospital and Clinics	Iowa City	Iowa	52242	Active, not recruiting
University of Kansas Cancer Center	Kansas City	Kansas	66160	Active, not recruiting
Dana-Farber Cancer Institute	Boston	Massachusetts	02115	Active, not recruiting
University of Michigan Comprehensive Cancer Center	Ann Arbor	Michigan	48109	Active, not recruiting
Mayo Clinic	Rochester	Minnesota	55905	Active, not recruiting
Washington University	St Louis	Missouri	63130	Recruiting
Nebraska Methodist Hospital	Omaha	Nebraska	68114	Recruiting
Roswell Park Comprehensive Cancer Center	Buffalo	New York	14203	Active, not recruiting
Memorial Sloan Kettering Cancer Center	New York	New York	10021	Recruiting
Duke University	Durham	North Carolina	27705	Active, not recruiting
The Cleveland Clinic Foundation	Cleveland	Ohio	44195	Active, not recruiting
The Ohio State University Comprehensive Cancer Center	Columbus	Ohio	43210	Active, not recruiting
University of Toledo Medical Center	Toledo	Ohio	43614	Withdrawn
Oregon Health & Science University (OHSU)	Portland	Oregon	97239	Active, not recruiting
Fox Chase Cancer Center	Philadelphia	Pennsylvania	19111	Active, not recruiting
University of Pittsburgh Medical Center - Hillman Cancer Center	Pittsburgh	Pennsylvania	15232	Active, not recruiting
University of Tennessee	Knoxville	Tennessee	37920	Withdrawn
Vanderbilt University Medical Center	Nashville	Tennessee	37232	Active, not recruiting
The University of Texas MD Anderson Cancer Center	Houston	Texas	77030-4009	Active, not recruiting
Fred Hutchinson Cancer Center	Seattle	Washington	98109	Active, not recruiting
University of Wisconsin - Carbone Cancer Center	Madison	Wisconsin	53705	Active, not recruiting

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 90 non-U.S. sites.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT05208047, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Jun 15, 2026 · Synced Sep 6, 2026

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