Study

Combining Ziftomenib and Imatinib to Treat Advanced Gastrointestinal Stromal Tumors

This study wants to find a dose of ziftomenib that people with advanced gastrointestinal stromal tumors (CIST) can handle safely when taken with imatinib. We also want to learn how well these two drugs work together.

Why this Research Matters

Some cancers, including gastrointestinal stromal tumors (GIST), have certain genetic changes in their cells that help the disease grow. These changes are supported by something called the menin pathway, which helps tumors form. Ziftomenib is the study drug that blocks this pathway. The goal is to stop or slow down how fast the tumor cells grow and divide. Because it is still being tested, ziftomenib has not yet been approved by the FDA yet. If you choose to join this study, there are three parts: screening, treatment, and long-term follow-up. During the screening period, the study team will learn about your medical history. You will have a physical exam and scans like electrocardiogram (ECG) and echocardiogram (ECHO). You also give blood samples and a sample of your tumor tissue. The treatment period is when you will take the study drug , ziftomenib. You will get one of two different doses. During treatment, you will also have a physical exam, blood tests, an ECG, and scans such as CT, PET or MRI will be done. You may have up to 9 study visits. The study team will contact you every 4 weeks to check on your health. Your participation in the study will about 2 years but will depend on how you handle the study drugs, how your cancer responds, and your overall health. You and your insurance will need to pay for regular medical care. You will not be paid for being in the study. You may get reimbursed for travel costs.

Who can Participate

Adult

You may be able to join this study if you advanced or metastatic KIT-mutant gastrointestinal stromal tumors and your cancer has gotten worse after using imatinib, either now or in the past. You cannot join this study if your cancer has spread to your central nervous system or if your heart’s left ventricular ejection fraction is below 50% during screening. Your doctor or study team will go over these requirements with you. More detailed information is available on ClinicalTrials.gov. You can click the NCT number link below to learn more about this study on ClinicalTrials.gov.