KQB198 in Combination With Imatinib in Participants With Advanced/Metastatic GIST in 1st Line Setting
Sponsor: Kumquat Biosciences Inc.
ClinicalTrials ID:NCT07406633
This clinical trial evaluates the safety, tolerability, and efficacy of oral KQB198 combined with imatinib in treating advanced/metastatic GIST. Participants must meet specific eligibility criteria to enroll. The study involves administering KQB198 and imatinib, both orally, to assess their combined therapeutic potential in a first-line treatment setting.
Patient Parameters
| Parameter | Options |
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Program Overview
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
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
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| USC Norris Comprehensive Cancer Center | 90033 | Los Angeles | California |
| Mayo Clinic - Jacksonville | 32224 | Jacksonville | Florida |
| Moffitt Cancer Center | 33612 | Tampa | Florida |
| University of Michigan Hospitals | 48109 | Ann Arbor | Michigan |
| Mayo Clinic - Rochester | 55905 | Rochester | Minnesota |
| Cleveland Clinic | 44195 | Cleveland | Ohio |
| UT MD Anderson Cancer Center | 77030 | Houston | Texas |
| Fred Hutchinson Cancer Center | 98195 | Seattle | Washington |
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