Clinical Trial 24154

• Overview

  Study Title:

  A Phase 2, Multicenter, Study Evaluating the Efficacy, Safety, Tolerability, Pharmacokinetics of KQB198 in Combination with Imatinib in Participants with Advanced/Metastatic GI Stromal Tumor in 1st Line Setting

  Summary:

  This study will test an experimental drug called KQB198 in combination with imatinib. The goal is to determine if this combination is safe and tolerable and assess how effective the combination is at treating GIST. Imatinib has been approved by the FDA for the treatment of different types of cancer including GIST.

  Objective:

  Primary Objective: - To evaluate the efficacy of KQB198 in combination with imatinib in GIST Secondary Objectives: - To evaluate the secondary efficacy endpoints of KQB198 and imatinib in GIST - To evaluate the safety and tolerability of KQB198 in combination with imatinib - To evaluate the plasma pharmacokinetics (PK) of KQB198 and imatinib

• Treatments

  Therapies:

  SOS1 Inhibitor; Tyrosine Kinase Inhibitor

  Medications:

  Imatinib (); KQB198 ()

• Inclusion Criteria

  Key Inclusion Criteria:
  • Unresectable or metastatic disease
  • Tissue confirmation of GIST
  • Valid results from local testing of blood or tumor tissue documenting the presence of a KIT mutation (must not have exon 9 mutation) or PDGFRA mutation (must not have PDGFRA D842V).
  • Measurable disease per RECIST v1.1.
  • Patients must be in 1st line of treatment for advanced or metastatic disease. Prior imatinib is allowed in adjuvant or neoadjuvant setting, as long as imatinib was stopped over 1 year ago.
  • Adequate organ function and performance status

• Exclusion Criteria

  Key Exclusion Criteria:
  • Unable to swallow or GI condition that prevents absorption.
  • Other active malignancies within the last 2 years.
  • History of hypersensitivity to any component of KQB198 or imatinib.

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