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Combining ziftomenib and imatinib for advanced gastrointestinal stromal tumors

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

Phase 1 Interventional Kura Oncology, Inc. · NCT06655246

This study is testing whether combining two medications, ziftomenib and imatinib, can help adults with advanced gastrointestinal stromal tumors who haven't responded well to imatinib alone.

Quick facts

PhasePhase 1
Study typeInterventional
Enrollment157 (estimated)
Ages18 Years and up
SexAll
SponsorKura Oncology, Inc. Industry-sponsored
Drugs / interventionsimatinib
Locations32 sites (Birmingham, Alabama and 31 other locations)
Trial IDNCT06655246 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the safety, tolerability, and preliminary antitumor activity of ziftomenib, an oral menin inhibitor, in combination with imatinib in adults with advanced gastrointestinal stromal tumors (GIST) who have previously been treated with imatinib. Participants must have documented disease progression on imatinib therapy and meet specific eligibility criteria, including having a measurable lesion. The study aims to determine if this combination therapy can provide better outcomes for patients with KIT mutant GIST.

Who should consider this trial

Good fit: Ideal candidates are adults with advanced or metastatic KIT mutant GIST who have experienced disease progression on imatinib therapy.

Not a fit: Patients with non-KIT mutation GIST or those with a history of other cancers that may interfere with study results are unlikely to benefit from this study.

Why it matters

Potential benefit: If successful, this combination therapy could offer a new treatment option for patients with advanced GIST who have not responded to prior imatinib treatment.

How similar studies have performed: Other studies have explored combination therapies for GIST, but the specific combination of ziftomenib and imatinib is novel and has not been extensively tested.

Eligibility criteria

Show full inclusion / exclusion criteria 
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 \<Grade 1 (or participant baseline) within 1 week before the first dose of study intervention.
* Participant, or legally authorized representative, must be able to understand and provide written informed consent before the first screening procedure.

Key Exclusion Criteria:

* Diagnosis of GIST without a KIT mutation or with a T670X KIT mutation.
* History of prior or current cancer that has potential to interfere with obtaining study results.
* Received a prohibited medication, including investigational therapy, less than 14 days or within 5 drug half-lives before the first dose of study intervention.
* Active central nervous system metastases.
* Uncontrolled intercurrent illness, including, but not limited to protocol defined cardiac disease.
* Mean corrected QT interval (QTcF) greater than 470ms.
* Left ventricular ejection fraction (LVEF) \<50%.
* Major surgery within 2 weeks before the first dose of study intervention.
* Is pregnant or breastfeeding.
* Gastrointestinal abnormalities that may impact taking study intervention by mouth.
* Actively bleeding, excluding hemorrhoidal or gum bleeding.

Where this trial is running

Birmingham, Alabama and 31 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Gastrointestinal Stromal TumorGastrointestinal Stromal CancerGastrointestinal Stromal NeoplasmGastrointestinal Stromal Tumor, MalignantGastrointestinal Stromal Cell Tumors
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.