Status:
ACTIVE_NOT_RECRUITING
(Peak) A Phase 3 Randomized Trial of CGT9486+Sunitinib vs. Sunitinib in Subjects With Gastrointestinal Stromal Tumors
Lead Sponsor:
Cogent Biosciences, Inc.
Conditions:
Advanced Gastrointestinal Stromal Tumors
Metastatic Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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...
Eligibility Criteria
Inclusion
- Key
- Histologically confirmed locally advanced, metastatic, and/or unresectable GIST. Molecular pathology report must be available for Part 2; if molecular pathology report is unavailable or inadequate, an archival or fresh tumor tissue sample will be required to evaluate mutational status prior to randomization.
- Documented disease progression on or intolerance to imatinib
- Subjects must have received the following treatment:
- DDI Substudy/Part 1a: Treatment with ≥1 prior lines of therapy for GIST Part 1b: Treatment with ≥2 prior TKI for GISTs Part 2: Prior treatment with imatinib only
- Have at least 1 measurable lesion according to mRECIST v1.1 (Part1a, Part 1b, Part 2)
- ECOG - 0 to 2
- Have clinically acceptable local laboratory screening results (clinical chemistry and hematology) within certain limits
- Key
Exclusion
- Known PDGFR driving mutations or known succinate dehydrogenase deficiency
- Clinically significant cardiac disease
- Major surgeries (eg, abdominal laparotomy) within 4 weeks of the first dose of study drug
- Gastrointestinal abnormalities including, but not limited to, significant nausea and vomiting, malabsorption, external biliary shunt, or significant bowel resection that would preclude adequate absorption
- Any active bleeding excluding hemorrhoidal or gum bleeding
- Seropositive for HIV 1 or 2, or positive for hepatitis B surface antigen or hepatitis C virus (HCV) antibody.
- Active, uncontrolled, systemic bacterial, fungal, or viral infections at Screening
- Received strong CYP3A4 inhibitors or inducers
- Received sunitinib within 3 weeks (Part 1a, Part 1b, DDI Substudy)
Key Trial Info
Start Date :
April 14 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2026
Estimated Enrollment :
442 Patients enrolled
Trial Details
Trial ID
NCT05208047
Start Date
April 14 2022
End Date
September 1 2026
Last Update
November 25 2025
Active Locations (126)
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1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35249
2
Mayo Clinic
Scottsdale, Arizona, United States, 85259
3
University of Arizona- Cancer Center
Tucson, Arizona, United States, 85719
4
City of Hope
Duarte, California, United States, 91010