for people ages 18 years and up (full criteria)
at San Francisco, California and other locations
study started
completion around



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 426 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 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.

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


Advanced Gastrointestinal Stromal Tumors, Metastatic Cancer, Sunitinib, Solid Tumors, Gastrointestinal Stromal Tumors, Gastrointestinal, KIT, Kinase Inhibitors, Growth Inhibitors, CGT9486, Unresectable, Metastatic, GIST, Bezuclastinib, PLX9486, CGT9486 plus sunitinib


You can join if…

Open to people ages 18 years and up

  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.
  2. Documented disease progression on or intolerance to imatinib
  3. Subjects must have received the following treatment:
    • 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
  4. Have at least 1 measurable lesion according to mRECIST v1.1
  5. ECOG - 0 to 2
  6. Have clinically acceptable local laboratory screening results (clinical chemistry and hematology) within certain limits

You CAN'T join if...

  1. Known PDGFR driving mutations or known succinate dehydrogenase deficiency
  2. Clinically significant cardiac disease
  3. Major surgeries (eg, abdominal laparotomy) within 4 weeks of the first dose of study drug
  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
  9. Received sunitinib within 3 weeks (Part 1a, Part 1b)


  • UCSF accepting new patients
    San Francisco California 94158 United States
  • University of California, Los Angeles (UCLA) accepting new patients
    Los Angeles California 90404 United States


accepting new patients
Start Date
Completion Date
Cogent Biosciences, Inc.
Phase 3 research study
Study Type
Expecting 426 study participants
Last Updated