(Peak) CGT9486 plus Sunitinib vs Sunitinib in advanced or metastatic GIST

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase 3, open-label, international trial evaluating CGT9486 in combination with sunitinib versus sunitinib alone in patients with advanced, metastatic, or unresectable GIST. The study includes a dose-confirmation and drug-interaction evaluation in a small initial cohort, followed by a larger randomized comparison enrolling about 388 patients. Participants must have progressed on or been intolerant to imatinib, with subgroup criteria requiring prior TKIs or specific mutational testing. Substudies will examine drug–drug interactions and mutational status when available. The trial is conducted at several major centers and is sponsored by Cogent Biosciences, with no listed collaborators.

Why it matters

Who can join: the full rules

Key Inclusion Criteria:

1. 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. (GIST 1L Substudy: must have documented mutation in KIT Exon 9 with an available molecular pathology report; archival or fresh tumor tissue sample will be required)
2. Documented disease progression on or intolerance to imatinib (Part 1a, Part 1b, Part 2, DDI Substudy)
3. 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
   * GIST 1L Substudy: No prior systemic therapy for GIST including adjuvant therapy. Exception: up to 10 subjects with ongoing imatinib therapy of ≤4 weeks
4. Have at least 1 measurable lesion according to mRECIST v1.1 (Part1a, Part 1b, Part 2, GIST 1L Substudy)
5. Eastern Cooperative Oncology Group (ECOG) Status

   * 0 to 2 (Part 1a, Part 1b, Part 2, DDI Substudy)
   * 0 to 1 (GIST 1L Substudy)
6. Have clinically acceptable local laboratory screening results (clinical chemistry and hematology) within certain limits

Key Exclusion Criteria:

1. Known Platelet-Derived Growth Factor Receptor (PDGFR) driving mutations or known succinate dehydrogenase deficiency (Part 1a, Part 1b, Part 2, DDI Substudy)
2. Clinically significant cardiac disease
3. Major surgeries (eg, abdominal laparotomy) within 4 weeks of the first dose of study drug (Part 1a, Part 1b, Part 2, DDI Substudy)
4. Gastrointestinal abnormalities including, but not limited to, significant nausea and vomiting, malabsorption, external biliary shunt, or significant bowel resection that would preclude adequate absorption
5. Any active bleeding excluding hemorrhoidal or gum bleeding
6. Seropositive for HIV 1 or 2, or positive for hepatitis B surface antigen or hepatitis C virus (HCV) antibody.
7. Active, uncontrolled, systemic bacterial, fungal, or viral infections at Screening
8. Received strong CYP3A4 inhibitors or inducers (Part 1a, Part 1b, Part 2, DDI Substudy)
9. Received sunitinib within 3 weeks (Part 1a, Part 1b, DDI Substudy)

Where it's running

• MedStar Washington Hospital Center
  Washington D.C., District of Columbia, United States Recruiting
• University of Miami - Sylvester Comprehensive Cancer Center
  Miami, Florida, United States Recruiting
• Orlando Health Cancer Institute
  Orlando, Florida, United States Recruiting
• Moffitt Cancer Center
  Tampa, Florida, United States Recruiting
• Northwestern University
  Chicago, Illinois, United States Recruiting
• Washington University
  St Louis, Missouri, United States Recruiting

+76 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Cogent Biosciences
• Email: peakinfo@cogentbio.com
• Phone: 617-945-5576

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.