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

• Status: Not yet recruiting
• Trial end date: 2026-09-01
• Target enrollment: 0
• Participant gender: All

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 388 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 multiple prior lines of therapy and 2) evaluating for drug-drug interactions between CGT9486 and sunitinib in approximately 18 patients who have received at least two prior lines of therapy. The second part of the study will enroll up to 350 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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Cogent Biosciences, Inc.
• Treatments: Sunitinib

Criteria

Key Inclusion Criteria:

1. Histologically confirmed locally advanced, metastatic, and/or unresectable GIST

2. Documented disease progression on or intolerance to imatinib

3. Have at least 1 measurable lesion according to mRECIST v1.1

4. ECOG - 0 to 2

5. Have clinically acceptable local laboratory screening results (clinical chemistry and hematology) within certain limits

Key Exclusion Criteria:

1. Prior treatment with < 2 Tyrosine Kinase Inhibitors (TKIs) (Part 1b only)

2. Prior treatment with any TKI other than imatinib (Part 2 only)

3. Known PDGFR alpha D842V mutation or known succinate dehydrogenase deficiency

4. Clinically significant cardiac disease

5. Major surgeries (eg, abdominal laparotomy) within 4 weeks of the first dose of study drug

6. Gastrointestinal abnormalities including, but not limited to, significant nausea and vomiting, malabsorption, external biliary shunt, or significant bowel resection that would preclude adequate absorption

7. Any active bleeding excluding hemorrhoidal or gum bleeding

8. Seropositive for HIV 1 or 2, or positive for hepatitis B surface antigen or hepatitis C virus (HCV) antibody.

9. Active, uncontrolled, systemic bacterial, fungal, or viral infections at Screening

10. Received strong CYP3A4 inhibitors or inducers

11. Received sunitinib within 3 weeks (Part 1a, Part 1b)