Study on KQB198 and Imatinib for Treating Advanced or Metastatic Gastrointestinal Stromal Tumors (GIST)

Sponsor: Kumquat Biosciences Inc.

Sponsor score: 0

ClinicalTrials ID:NCT07406633

This clinical trial is testing a new drug, KQB198, in combination with an existing cancer treatment, imatinib, to see if it is safe and effective for patients with advanced or metastatic Gastrointestinal Stromal Tumors (GIST).

Patient Parameters

Program Overview

The purpose of this study is to evaluate the safety and effectiveness of a new drug called KQB198 when used together with imatinib, a medication already approved by the FDA for treating various cancers, including GIST. Researchers aim to find out if this combination can help treat patients with advanced or metastatic GIST, which is a type of cancer that occurs in the digestive tract.

Eligibility Criteria

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.

Locations

FACILITYZIPCITYSTATE
USC Norris Comprehensive Cancer Center90033Los AngelesCalifornia
Mayo Clinic - Jacksonville32224JacksonvilleFlorida
Moffitt Cancer Center33612TampaFlorida
University of Michigan Hospitals48109Ann ArborMichigan
Mayo Clinic - Rochester55905RochesterMinnesota
Cleveland Clinic44195ClevelandOhio
UT MD Anderson Cancer Center77030HoustonTexas
Fred Hutchinson Cancer Center98195SeattleWashington

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