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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

Primary Investigator
Schuetze, Scott
Status
OPEN TO ACCRUAL
Phase
II
NCT Number
NCT07406633
UM Number
2026.004
Age Group
Adults
Management Group
CTSU - Oncology
Oncology Group
Connective Tissue Oncology
ID (Protocol)
65375
Secondary Protocol No
HUM00286955
Scope
Unspecified
Sponsor Type
Industry
Disease Site
Soft Tissue
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.

Eligibility: Inclusion Criteria
  •   All Participants:
  •   * 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
  •   Participants are excluded from the study if any of the following criteria apply:
  •   * 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.