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Recruiting Phase 2 NCT07406633

KQB198 in Combination With Imatinib in Participants With Advanced/Metastatic GIST in 1st Line Setting

Phase 2 – studying effectiveness and dosage
Conditions: GIST - Gastrointestinal Stromal Tumor GIST GIST Metastatic Cancer Gastro Intestinal Stromal Tumour Gastrointestinal Tumors

Sponsor: Kumquat Biosciences Inc.

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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.
Who can participate
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.
Interventions
KQB198
DRUG
Imatinib (Gleevec)
DRUG
Locations 1
United States (1)
Cleveland Clinic
Cleveland , Ohio
Technical details
Status
Recruiting
Phase
Phase 2
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
01.05.2026
Completion date
01.10.2028
Registry ID
NCT07406633
Source
clinicaltrials.gov
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