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Study of Ziftomenib and Imatinib for Advanced GIST

This study is looking at a combination of two drugs, ziftomenib and imatinib mesylate, for adults with advanced gastrointestinal stromal tumors (GIST). GIST is a type of cancer that starts in the digestive tract. You might be able to join if your GIST has a specific change in the KIT gene and has gotten worse after treatment with imatinib. The study aims to see how safe the combination is, how well people tolerate it, and if it helps shrink tumors. We are also looking at how many people benefit from the treatment. The current status of this study is unclear.

Study design
This interventional study plans to enroll 157 participants. It is evaluating the safety and effectiveness of ziftomenib in combination with imatinib.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The study will measure clinical benefit for up to 2 years after starting treatment with ziftomenib.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06655246

A Study of Ziftomenib in Combination With Imatinib in Patients With Advanced Gastrointestinal Stromal Tumors (GIST)

Recruiting
PHASE1Ages 18+InterventionalTreatment
Kura Oncology, Inc.
~157 participants
Updated 2026-02-05 on ClinicalTrials.gov
What's tested:ziftomenibimatinib mesylate

At a glance

Recruiting sites
32 of 32 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Dose Escalation: Dose Limiting Toxicity (DLT)
Measured over Cycle 1 (first 28 day cycle)
+2 more outcomes measured

Conditions

Gastrointestinal Stromal Tumor (GIST)
Gastrointestinal Stromal Cancer
Gastrointestinal Stromal Neoplasm
Gastrointestinal Stromal Tumor, Malignant
Gastrointestinal Stromal Cell Tumors

Explore related trials

Gastrointestinal Stromal TumorKIT Gene

Where it's being run

32 sites across 21 states
California5
Texas3
Colorado2
Florida2
Massachusetts2
Pennsylvania2
Tennessee2
Alabama1

Who to contact

Kura Medical Information 844-KURAONC
[email protected]
844-587-2662
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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.

Exclusion

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.

What this trial measures

  • Dose Escalation: Dose Limiting Toxicity (DLT)Cycle 1 (first 28 day cycle)

    Rate of DLTs per dose level

  • Descriptive statistics of Adverse Events (AEs)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

  • Dose Expansion: Clinical benefit rate (CBR)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