RECRUITING

A Study of Ziftomenib, an Oral Menin Inhibitor, in Combination With Imatinib in Patients With Advanced Gastrointestinal Stromal Tumors (GIST)

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Conditions

Gastrointestinal Stromal Tumor (GIST)Gastrointestinal Stromal Tumor (GIST) of the Gastrointestinal TractGastrointestinal Stromal CancerGastrointestinal Stromal NeoplasmGastrointestinal Stromal Tumor, MalignantGastrointestinal Stromal Cell TumorsGastrointestinal Stromal Tumor

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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

Quick Facts

Study Start:2025-04
Study Completion:2028-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06655246

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Documented diagnosis of advanced or metastatic KIT mutant GIST.
  2. * Documented disease progression on imatinib therapy as current or prior treatment.
  3. * Eastern Cooperative Oncology Group (ECOG) performance status (PS) of ≤2 at screening.
  4. * At least 1 measurable lesion per mRECIST.
  5. * Negative pregnancy test for female patients of childbearing potential.
  6. * Adequate organ function per protocol requirements.
  7. * 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.
  8. * Participant, or legally authorized representative, must be able to understand and provide written informed consent prior to the first screening procedure.
  1. * Diagnosis of non-KIT mutation or a T670X KIT mutation-driven GIST.
  2. * History of prior or currently has cancer which has potential to interfere with obtaining study results.
  3. * 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.
  4. * Active central nervous system metastases.
  5. * Uncontrolled intercurrent illness, including, but not limited to protocol defined cardiac disease.
  6. * Mean corrected QT interval (QTcF) greater than 470ms.
  7. * Left ventricular ejection fraction (LVEF) \<50%.
  8. * Major surgery within 2 weeks prior to the first dose of study intervention.
  9. * Is pregnant or lactating.
  10. * Gastrointestinal abnormalities that may impact taking study intervention by mouth.
  11. * Actively bleeding, excluding hemorrhoidal or gum bleeding.

Contacts and Locations

Study Contact

Clinical Operations
CONTACT
858-500-8800
KO-MEN-015@kuraoncology.com

Study Locations (Sites)

Memorial Sloan Kettering Cancer Center
New York, New York, 10022
United States
MD Anderson Cancer Center
Houston, Texas, 77030
United States

Collaborators and Investigators

Sponsor: Kura Oncology, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-04
Study Completion Date2028-12

Study Record Updates

Study Start Date2025-04
Study Completion Date2028-12

Terms related to this study

Keywords Provided by Researchers

  • Gastrointestinal Stromal Tumor
  • Gastrointestinal Stromal Cancer
  • Gastrointestinal Stromal Neoplasm

Additional Relevant MeSH Terms

  • Gastrointestinal Stromal Tumor (GIST)
  • Gastrointestinal Stromal Tumor (GIST) of the Gastrointestinal Tract
  • Gastrointestinal Stromal Cancer
  • Gastrointestinal Stromal Neoplasm
  • Gastrointestinal Stromal Tumor, Malignant
  • Gastrointestinal Stromal Cell Tumors