KQB198 in Combination With Imatinib in Participants With Advanced/Metastatic GIST in 1st Line Setting (SynerGIST-1st Line)
Recruiting now · Phase 2
Conditions studied: GIST - Gastrointestinal Stromal Tumor, GIST, GIST Metastatic Cancer, Gastro Intestinal Stromal Tumour, Gastrointestinal Tumors
In brief
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.
Key facts
- Study ID
- NCT07406633
- Run by
- Kumquat Biosciences Inc.
- People needed
- 46
- Starts
- 2026-06-01
- Expected to finish
- 2028-10-01
- Last updated by the study team
- 2026-07-10
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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.
Where it is running
- USC Norris Comprehensive Cancer Center — Los Angeles, California, United States (enrolling)
- Mayo Clinic - Jacksonville — Jacksonville, Florida, United States (enrolling)
- Sylvester Comprehensive Cancer Center — Miami, Florida, United States (enrolling)
- Moffitt Cancer Center — Tampa, Florida, United States (enrolling)
- University of Chicago Medical Center — Chicago, Illinois, United States (enrolling)
- University of Iowa Health Care — Iowa City, Iowa, United States (enrolling)
- Dana-Farber Cancer Institute — Boston, Massachusetts, United States (enrolling)
- University of Michigan Hospitals — Ann Arbor, Michigan, United States (enrolling)
- Mayo Clinic - Rochester — Rochester, Minnesota, United States (enrolling)
- Northwell Health/R.J. Zuckerberg Cancer Center — Lake Success, New York, United States (enrolling)
- University of North Carolina at Chapel Hill — Chapel Hill, North Carolina, United States (enrolling)
- Cleveland Clinic — Cleveland, Ohio, United States (enrolling)
- Oregon Health & Science University — Portland, Oregon, United States (enrolling)
- UT MD Anderson Cancer Center — Houston, Texas, United States (enrolling)
- Huntsman Cancer Institute — Salt Lake City, Utah, United States (enrolling)
- Fred Hutchinson Cancer Center — Seattle, Washington, United States (enrolling)
Full record on ClinicalTrials.gov
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