About this trial

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 criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • KQB198
  • Imatinib (Gleevec)

Treatment groups

46 Participants
are divided into 1 treatment group

Locations

8
California
USC Norris Comprehensive Cancer Center90033, Los Angeles United States
Florida
Mayo Clinic - Jacksonville32224, Jacksonville United States
Moffitt Cancer Center33612, Tampa United States
Michigan
University of Michigan Hospitals48109, Ann Arbor United States

Sponsors and collaborators

Kumquat Biosciences Inc.

Lead sponsor