NCT07406633 KQB198 in Combination With Imatinib in Participants With Advanced/Metastatic GIST in 1st Line Setting
| NCT ID | NCT07406633 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Kumquat Biosciences Inc. |
| Condition | GIST - Gastrointestinal Stromal Tumor |
| Study Type | INTERVENTIONAL |
| Enrollment | 46 participants |
| Start Date | 2026-05 |
| Primary Completion | 2027-10 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 46 participants in total. It began in 2026-05 with a primary completion date of 2027-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07406633 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying GIST - Gastrointestinal Stromal Tumor. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07406633 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07406633 currently recruiting?
Yes, NCT07406633 is actively recruiting participants. Contact the research team at kumquatstudies@kumquatbio.com for enrollment information.
Where is the NCT07406633 trial being conducted?
This trial is being conducted at Los Angeles, United States, Jacksonville, United States, Tampa, United States, Ann Arbor, United States and 4 additional locations.
Who is sponsoring the NCT07406633 clinical trial?
NCT07406633 is sponsored by Kumquat Biosciences Inc.. The trial plans to enroll 46 participants.