Combining ziftomenib and imatinib for advanced gastrointestinal stromal tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

Key Inclusion Criteria:

* 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.
* 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 it's running

• University of Alabama at Birmingham
  Birmingham, Alabama, United States Recruiting
• Mayo Clinic Cancer Center
  Phoenix, Arizona, United States Recruiting
• University of California, San Diego
  La Jolla, California, United States Recruiting
• University of Southern California
  Los Angeles, California, United States Recruiting
• University Of California, Irvine
  Orange, California, United States Recruiting
• Stanford Cancer Institute
  Palo Alto, California, United States Recruiting

Study contacts

• Study coordinator: Kura Medical Information 844-KURAONC
• Email: medinfo@kuraoncology.com
• Phone: 844-587-2662

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Velzatinib vs. Imatinib as frontline treatment for metastatic or unresectable GIST

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.