A Phase 1 Study of Ziftomenib Plus Imatinib in People With Advanced Gastrointestinal Stromal Tumors

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Full 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

Purpose

Researchers want to find the best dose of ziftomenib to give with imatinib in people with advanced gastrointestinal stromal tumors (GIST). The people in this study have GIST that keeps growing after treatment.

Ziftomenib blocks a protein pathway called the menin pathway, which plays an important role in cancer growth and survival. By blocking the menin pathway, ziftomenib may help slow or stop the growth of cancer cells. Ziftomenib and imatinib are both taken orally (by mouth).

Who Can Join

To join this study, there are a few conditions. You must:

  • Have GIST that has spread beyond its original site and keeps growing after treatment. If you are taking imatinib and this drug is no longer working well, you may be able to join the study. 
  • Have GIST with a mutation (change) in the KIT gene.
  • Be able to walk and do routine activities for more than half the time you are awake.
  • Be age 18 or older.

Contact

For more information or to see if you can join this study, please call Dr. Mrinal Gounder’s office at 646-888-4167.

Protocol

25-029

Phase

Phase I (phase 1)

Investigator

Co-Investigators

ClinicalTrials.gov ID

NCT06655246