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Gastrointestinal Stromal Tumor (GIST)Phase 1NCT06655246

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

A Phase 1 study testing ziftomenib and imatinib mesylate in people with Gastrointestinal Stromal Tumor (GIST) and Gastrointestinal Stromal Cancer, run by Kura Oncology, Inc. at 32 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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 as current or prior therapy, or are treatment naive. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
ziftomenib and imatinib mesylate
Could I receive a placebo?
No, everyone receives an active treatment
How many people
135 participants
Where
32 sitesUnited States
Study dates
27 Mar 2025to Jun 2030
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Documented diagnosis of advanced/metastatic KIT-mutant GIST
  • Documented disease progression on imatinib as current or prior therapy or is treatment naïve, as follows:
  • DES: Participant is progressing or progressed on imatinib in any prior line of therapy.
  • EXP Cohort A: Participant is progressing or progressed on imatinib and has not received additional intervening therapy before study participation.
  • EXP Cohort B: Participant has progressed on imatinib and sunitinib only and has not received additional intervening therapy before study participation.
  • EXP Cohort C: Participant has newly diagnosed advanced/metastatic GIST and is treatment naïve in the advanced/metastatic setting.
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  • 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.

Who cannot join

  • 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.
Show all 11Show fewer
  • 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.

Trial locations and contacts

32 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Kura Medical Information 844-KURAONC contact

844-587-2662

medinfo@kuraoncology.com

32 sites in 1 country

United States32 sites, 32 recruiting

  • University of Michigan

    Ann Arbor, Michigan, 48109

    Recruiting

  • University of Colorado Cancer Center

    Aurora, Colorado, 80045

    Recruiting

  • Johns Hopkins University

    Baltimore, Maryland, 21287

    Recruiting

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35233

    Recruiting

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

    Recruiting

  • Harvard University

    Boston, Massachusetts, 02215

    Recruiting

  • Northwestern University

    Chicago, Illinois, 60611

    Recruiting

  • Ohio State University

    Columbus, Ohio, 43210

    Recruiting

  • Sarah Cannon Research Institute

    Dallas, Texas, 75230

    Recruiting

  • Sarah Cannon Research Institute

    Denver, Colorado, 80220

    Recruiting

  • Duke University Medical Center

    Durham, North Carolina, 27710

    Recruiting

  • University of Texas

    Houston, Texas, 77030

    Recruiting

  • University of Iowa

    Iowa City, Iowa, 52242

    Recruiting

  • Mayo Clinic Cancer Center

    Jacksonville, Florida, 32224

    Recruiting

  • University of California, San Diego

    La Jolla, California, 92093

    Recruiting

  • University of Southern California

    Los Angeles, California, 90033

    Recruiting

  • University of Miami

    Miami, Florida, 33136

    Recruiting

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

    Recruiting

  • Sarah Cannon Research Institute

    Nashville, Tennessee, 37203

    Recruiting

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232

    Recruiting

  • Yale University School of Medicine

    New Haven, Connecticut, 06511

    Recruiting

  • Memorial Sloan-Kettering Cancer Center

    New York, New York, 10065

    Recruiting

  • University Of California, Irvine

    Orange, California, 92868

    Recruiting

  • Stanford Cancer Institute

    Palo Alto, California, 94304

    Recruiting

  • Thomas Jefferson University

    Philadelphia, Pennsylvania, 19107

    Recruiting

  • Temple University Health System

    Philadelphia, Pennsylvania, 19111

    Recruiting

  • Mayo Clinic Cancer Center

    Phoenix, Arizona, 85054

    Recruiting

  • Oregon Health & Science University

    Portland, Oregon, 97239

    Recruiting

  • Mayo Clinic Cancer Center

    Rochester, Minnesota, 55905

    Recruiting

  • University of Utah

    Salt Lake City, Utah, 84112

    Recruiting

  • University of Texas Health Science Center

    San Antonio, Texas, 78229

    Recruiting

  • UCLA Santa Monica Medical Center

    Santa Monica, California, 90404

    Recruiting

Other trials in United States

About this study

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

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 as current or prior therapy, or are treatment naive.

Being tested
ziftomenib, imatinib mesylate
Keywords
Gastrointestinal Stromal Tumor, Gastrointestinal Stromal Cancer, Gastrointestinal Stromal Neoplasm
Medical subject headings
Gastrointestinal Stromal Tumors

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ziftomenibDrug

    menin inhibitor

  • imatinib mesylateDrug

    Also called Gleevec

    kinase inhibitor

Study groups in NCT06655246
Study groupRoleWhat they receive
Dose EscalationExperimentalIntervention: ziftomenib plus imatinib. Participants with advanced/metastatic GIST who are progressing/progressed on imatinib
Receives: Drug: ziftomenib; Drug: imatinib mesylate
Dose Expansion Cohort AExperimentalIntervention: ziftomenib plus imatinib. Participants with advanced/metastatic GIST who are progressing/progressed on imatinib
Receives: Drug: ziftomenib; Drug: imatinib mesylate
Dose Expansion Cohort BExperimentalIntervention: ziftomenib plus imatinib. Participants with advanced/metastatic GIST who progressed on imatinib and sunitinib only
Receives: Drug: ziftomenib; Drug: imatinib mesylate
Dose Expansion Cohort CExperimentalIntervention: ziftomenib plus imatinib. Participants with newly diagnosed advanced/metastatic GIST who are treatment-naive in the advanced/metastatic setting
Receives: Drug: ziftomenib; Drug: imatinib mesylate

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Dose Limiting Toxicity (DLT) (Dose Expansion)

    Rate of DLTs per dose level

    Measured: Cycle 1 (first 28 day cycle)

  2. Descriptive statistics of Adverse Events (AEs)

    Per the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) v5.0

    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

  3. Clinical Benefit Rate (CBR) (Dose Escalation and Dose Expansion Cohorts A and B only)

    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

    Measured: Up to 2 years following start of treatment with ziftomenib

  4. Overall Response Rate (ORR) (Dose Expansion Cohort C)

    ORR is CR + PR assessed per RECIST v1.1 modified for GIST

    Measured: Up to 2 years following start of treatment with ziftomenib

Secondary outcomes (12)

  1. Overall Response Rate (ORR) (Dose Expansion Cohorts A and B)

    ORR is CR + PR assessed per RECIST v1.1 modified for GIST

    Measured: Up to 2 years following start of treatment with ziftomenib

  2. Duration of Response (DoR)

    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

    Measured: Up to 2 years following start of treatment with ziftomenib

  3. Progression-Free Survival (PFS)

    Assessed per RECIST v1.1 modified for GIST

    Measured: Up to 2 years following start of treatment with ziftomenib

  4. Overall Survival (OS)

    Defined as the time from first dose of ziftomenib or imatinib (whichever is dosed first) until death from any cause

    Measured: Up to 2 years following start of treatment with ziftomenib

  5. Maximum plasma concentration (Cmax)

    Cmax of ziftomenib

    Measured: Day 1 of each cycle; each cycle is 28 days

  6. Time to maximum plasma concentration (Tmax)

    Tmax of ziftomenib

    Measured: Day 1 of each cycle; each cycle is 28 days

  7. Area under the concentration-time curve from time zero to the time of the last quantifiable concentration (AUC 0-last)

    AUC 0-last of ziftomenib

    Measured: Day 1 of each cycle; each cycle is 28 days

  8. Area under the concentration-time curve over a dosing interval (AUC tau)

    AUC 0-t of ziftomenib

    Measured: Day 1 of each cycle; each cycle is 28 days

  9. Maximum plasma concentration (Cmax)

    Cmax of imatinib

    Measured: Day 1 of each cycle; each cycle is 28 days

  10. Time to maximum plasma concentration (Tmax)

    Tmax of imatinib

    Measured: Day 1 of each cycle; each cycle is 28 days

  11. Area under the concentration-time curve from time zero to the time of the last quantifiable concentration (AUC 0-last)

    AUC 0-last of imatinib

    Measured: Day 1 of each cycle; each cycle is 28 days

  12. Area under the concentration-time curve over a dosing interval (AUC tau)

    AUC 0-t of imatinib

    Measured: Day 1 of each cycle; each cycle is 28 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Oct 2024
  2. Study start27 Mar 2025
  3. Primary completionJun 2029 (estimated)
  4. Study completionJun 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
135 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06655246
Sponsor's protocol ID
KO-MEN-015
Status last verified
Oct 2026
First submitted
14 Oct 2024
Last updated
27 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No
Expanded access
Available

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing ziftomenib and imatinib mesylate in people with Gastrointestinal Stromal Tumor (GIST) and Gastrointestinal Stromal Cancer, run by Kura Oncology, Inc. at 32 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 32 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Kura Medical Information 844-KURAONC (844-587-2662, medinfo@kuraoncology.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dose Limiting Toxicity (DLT) (Dose Expansion) (time frame: Cycle 1 (first 28 day cycle)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06655246.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2026.

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