A Study of Ziftomenib in Combination With Imatinib in Patients With Advanced Gastrointestinal Stromal Tumors (GIST)
← catalyst calendarNCT06655246 · readout ≤ 499 d
Sponsored by Kura Oncology, Inc. (industry) · KURA — their whole pipeline →.
Phase
Phase 1
Status
Recruiting
Study type
Interventional
Design
Non randomized · None · Treatment
Enrollment
157estimated
Sites
32
Country
United States
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2025-03-27 | actual | When the study began enrolling |
| Primary completion | Dec 2027 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | Dec 2028 | estimated | The whole study's end, after follow-up |
| First posted | 2024-10-23 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-02-05 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Conditions
- Gastrointestinal Stromal Tumor (GIST)
- Gastrointestinal Stromal Cancer
- Gastrointestinal Stromal Neoplasm
- Gastrointestinal Stromal Tumor, Malignant
- Gastrointestinal Stromal Cell Tumors
Interventions
- Drug: ziftomenib
- Drug: imatinib mesylate — also filed as Gleevec
Primary outcomes
what the primary-completion date above is the date OFDose Escalation: Dose Limiting Toxicity (DLT)
measured Cycle 1 (first 28 day cycle)
Descriptive statistics of Adverse Events (AEs)
measured First dose of ziftomenib up to and including 28 days after last dose of ziftomenib, or if the participant is lost to follow-up, whichever comes first
Dose Expansion: Clinical benefit rate (CBR)
measured Up to 2 years following start of treatment with ziftomenib
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