> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-study-of-ziftomenib-in-combination-with-imatinib-in-31470af4-d3ca-43bc-bd8b-eeb7780e380d > Record changed: 2026-10-13 # A Study of Ziftomenib in Combination With Imatinib in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) NCT06655246 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06655246) Phase Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06655246) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06655246) Participants 157 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06655246) Lead sponsor Kura Oncology, Inc. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06655246) Start date 2025-03-27 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06655246) Number of sites 32 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06655246) ## Title and summary **Summary** In this clinical trial, the safety, tolerability, and preliminary antitumor activity of ziftomenib in combination with imatinib will be evaluated in adults with gastrointestinal stromal tumors (GIST) who have been treated previously with imatinib. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06655246) **Short title** A Study of Ziftomenib in Combination With Imatinib in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06655246) **Official title** A Phase 1a/1b Study of the Safety, Pharmacokinetics, and Antitumor Activity of the Oral Menin Inhibitor Ziftomenib in Combination With Imatinib in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) After Imatinib Failure Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06655246) ## Status and phase **Control arm** Open label Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06655246) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06655246) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06655246) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06655246) **Phase** Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06655246) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06655246) ## Dates **Completion date** 2028-12-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06655246) **First posted** 2024-10-23 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06655246) **Registry last updated** 2026-02-05 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06655246) **Primary completion date** 2027-12-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06655246) **Start date** 2025-03-27 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06655246) ## Size and sites **Participants** 157 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06655246) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06655246) **Planned participants** 157 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06655246) **Protocol amendments** 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06655246) **Number of sites** 32 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06655246) ## Sponsor and oversight **Data monitoring committee** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06655246) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06655246) **Lead sponsor** Kura Oncology, Inc. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06655246) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06655246) ## Identifiers **Registry ID** NCT06655246 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06655246) **ClinicalTrials.gov ID** NCT06655246 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06655246) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06655246) ## Study design **Allocation** Not randomised **Model** Single group **Purpose** Treatment **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06655246) ## Outcomes ### Primary outcomes 1. Dose Escalation: Dose Limiting Toxicity (DLT) Timeframe: Cycle 1 (first 28 day cycle) Rate of DLTs per dose level 2. Descriptive statistics of Adverse Events (AEs) Timeframe: 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 Per the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) v5.0 3. Dose Expansion: Clinical benefit rate (CBR) Timeframe: Up to 2 years following start of treatment with ziftomenib CBR is the rate of participants achieving complete response (CR), partial response (PR), or stable disease (SD), assessed per Response Criteria in Solid Tumors (RECIST) v1.1 modified for GIST ### Secondary outcomes 1. Recommended Phase 2 Dose Determination and Dose Expansion: CBR Timeframe: Up to 2 years following start of treatment with ziftomenib CBR is CR + PR + SD assessed per RECIST v1.1 modified for GIST 2. Overall Response Rate (ORR) Timeframe: Up to 2 years following start of treatment with ziftomenib ORR is CR + PR assessed per RECIST v1.1 modified for GIST 3. Progression Free Survival (PFS) Timeframe: Up to 2 years following start of treatment with ziftomenib Assessed per RECIST v1.1 modified for GIST 4. Duration of Response (DoR) Timeframe: Up to 2 years following start of treatment with ziftomenib Defined as the time from the first response (CR or PR assessed per RECIST v1.1 modified for GIST) to disease progression or death from any cause 5. Overall Survival (OS) Timeframe: Up to 2 years following start of treatment with ziftomenib Defined as the time from first dose of ziftomenib or imatinib (whichever is dosed first) until death from any cause 6. Maximum plasma concentration (Cmax) Timeframe: Day 1 of each cycle; each cycle is 28 days Cmax of ziftomenib 7. Time to maximum plasma concentration (Tmax) Timeframe: Day 1 of each cycle; each cycle is 28 days Tmax of ziftomenib 8. Area under the concentration-time curve from time zero to the time of the last quantifiable concentration (AUC 0-last) Timeframe: Day 1 of each cycle; each cycle is 28 days AUC 0-last of ziftomenib 9. Area under the concentration-time curve over a dosing interval (AUC tau) Timeframe: Day 1 of each cycle; each cycle is 28 days AUC tau of ziftomenib 10. Maximum plasma concentration (Cmax) Timeframe: Day 1 of each cycle; each cycle is 28 days Cmax of imatinib 11. Time to maximum plasma concentration (Tmax) Timeframe: Day 1 of each cycle; each cycle is 28 days Tmax of imatinib 12. Area under the concentration-time curve from time zero to the time of the last quantifiable concentration (AUC 0-last) Timeframe: Day 1 of each cycle; each cycle is 28 days AUC 0-last of imatinib 13. Area under the concentration-time curve over a dosing interval (AUC tau) Timeframe: Day 1 of each cycle; each cycle is 28 days AUC tau of imatinib Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06655246) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Healthy volunteers** No Key Inclusion Criteria: - Documented diagnosis of advanced/metastatic KIT-mutant GIST. - Documented disease progression on imatinib as current or prior therapy. - Eastern Cooperative Oncology Group (ECOG) performance status of ≤2 at screening. - At least 1 measurable lesion per RECIST v1.1 modified for GIST. - Negative pregnancy test for participants of childbearing potential. - Adequate organ function per protocol requirements. - Resolution of all clinically significant toxicities from prior therapy to