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Purpose

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.

Conditions

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Documented diagnosis of advanced or metastatic KIT mutant GIST. - Documented disease progression on imatinib therapy as current or prior treatment. - Eastern Cooperative Oncology Group (ECOG) performance status (PS) of ≤2 at screening. - At least 1 measurable lesion per mRECIST. - Negative pregnancy test for female patients of childbearing potential. - Adequate organ function per protocol requirements. - Resolution of all clinically significant toxicities from prior therapy to ≤Grade 1 (or patient baseline) within 1 week prior to the first dose of study drug. - Participant, or legally authorized representative, must be able to understand and provide written informed consent prior to the first screening procedure.

Exclusion Criteria

  • Diagnosis of non-KIT mutation or a T670X KIT mutation-driven GIST. - History of prior or currently has cancer which 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 prior to 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 prior to the first dose of study intervention. - Is pregnant or lactating. - Gastrointestinal abnormalities that may impact taking study intervention by mouth. - Actively bleeding, excluding hemorrhoidal or gum bleeding.

Study Design

Phase
Phase 1
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Dose Escalation
  • Drug: ziftomenib
    menin inhibitor
  • Drug: imatinib mesylate
    kinase inhibitor
    Other names:
    • Gleevec
Experimental
Recommended Phase 2 Dose Determination
  • Drug: ziftomenib
    menin inhibitor
  • Drug: imatinib mesylate
    kinase inhibitor
    Other names:
    • Gleevec
Experimental
Dose Expansion
  • Drug: ziftomenib
    menin inhibitor
  • Drug: imatinib mesylate
    kinase inhibitor
    Other names:
    • Gleevec

Recruiting Locations

University of Alabama at Birmingham
Birmingham 4049979, Alabama 4829764 35233

More Details

Status
Recruiting
Sponsor
Kura Oncology, Inc.

Study Contact

Kura MedInfo 844-KURAONC
844-587-2662
KO-MEN-015@kuraoncology.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.