Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-26 @ 3:19 PM
NCT ID:
NCT07406633
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07406633
Study Brief:
Protocol Section:
NCT07406633