Trial NCT07406633
KQB198 in Combination With Imatinib in Participants With Advanced/Metastatic GIST in 1st Line Setting (SynerGIST-1st Line)
- Phase
- Phase 2
- Sponsor
- Kumquat Biosciences Inc.
- Conditions
- GIST - Gastrointestinal Stromal Tumor; GIST; GIST Metastatic Cancer; Gastro Intestinal Stromal Tumour; Gastrointestinal Tumors
- Ages
- 18+ years
Eligibility criteria
Highlighted: restrictions our model extracted, each a verbatim quote (pink = excludes outright, blue = only under conditions).
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.Prior malignancy
* History of hypersensitivity to any component of KQB198 or imatinib.
Restrictions found (1)
- Prior malignancyConditionalexclusion
within 2 years
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Recruiting in Massachusetts
- Dana-Farber Cancer Institute · Boston, Suffolk County