Clinical Trial 22259

• Overview

  Study Title:

  (Peak) A Phase 3 Randomized, Open-label, Multicenter Clinical Study of GT9486+Sunitinib vs Sunitinib in Subjects with Locally Advanced, Unresectable, or Metastatic Gastrointestinal Stromal Tumors

  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 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.

  Objective:

  Primary * To confirm the dose of a modified CGT9486 formulation to have a similar target exposure to that previously studied in subjects with GIST Secondary * To characterize the safety of CGT9486+sunitinib in subjects with GIST * To evaluate efficacy parameters of CGT9486+sunitinib in subjects with GIST

• Treatments

  Therapies:

  Immunotherapy; Therapy (NOS)

  Medications:

  Bezuclastinib (CGT9486); CGT9486 (Bezuclastinib); Sunitinib ()

• Inclusion Criteria

  • 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.
  • Must provide a blood sample at Screening to be used for ctDNA analysis (Part 2). ctDNA results may be used to determine Part 2 enrollment
  • Documented disease progression on or intolerance to imatinib
  • Participants 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 Have at least 1 measurable lesion according to mRECIST v1.1
  • ECOG - 0 to 2
  • Have clinically acceptable local laboratory screening results (clinical chemistry and hematology) within certain limits

• Exclusion Criteria

  • 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)

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