Find a Research Study

This study is looking to learn more about a study drug called IDRX-42. Unlike sunitinib, IDRX-42 has not been approved by the FDA to treat GIST. This research is important because it may give another treatment option for people whose GIST has spread to other parts of the body or cannot be removed with surgery, and whose cancer did not respond to imatinib or is getting worse. If you decide to join the study, you will have a first visit to find out if you can take part in the study. During this visit, the study team will ask questions about you, your cancer, your medical history, treatment you have had in the past, and any medicines you have taken or are taking at this time. At this visit, your height, weight, and other vital signs will be measured, and you will have a physical exam. Blood and urine samples will also be collected. You will have tests to check how your heart is working, such as an ECG and an ECHO. You will also have a CT scan and/or MRI scan, so your tumor can be checked. In addition, the study team will review a tumor tissue sample from a past procedure. If a previous sample is not available, you may need to have a new tumor tissue sample. If you are eligible to join the study, you will be randomly placed into one of two groups, either IDRX-42 or sunitinib. You cannot choose which treatment you get. The group you are placed in is chosen by chance, like flipping a coin. Depending on whether you get IDRX-42 or sunitinib, you will have specific instructions on how much drug to take and how often to take it. You will take the drug at home and return to the clinic regularly for checkups, blood tests, heart tests, and scans, like those done during your first visit. These tests will help monitor your health and see how your tumor is responding. You will also use an app on a phone or tablet to record how you are feeling and when you take your medicine. After you end treatment, you will have a follow-up visit within 14 days. About 30 days after your last dose of the study drug, you will either return to the clinic or be contacted by phone. After that, you will get a phone call every 3 months so the study team can check how you are doing. Your participation in this study may last up to 60 months, including the follow up period. You may be eligible for reimbursement for travel expenses related to study visits. You and your insurance will be responsible for the costs of your normal heath care, including routine visits, procedures, and treatments for your condition. You will not be charged for study visits, study procedures, the study drug, or care that is provided only for research purposes.

Who can Participate

You may be eligible to join the study if you are 18 years of age or older and have advanced GIST that has spread to other parts of your body, and/or cannot be removed with surgery, your disease is getting worse, or you are having side effects while taking a cancer drug called imatinib. You must also have results from a tumor test that looks for certain gene changes. You may not be able to join the study if your tumor has certain gene changes that are not being studied or if you have untreated or active cancer in your brain or spinal cord. More details about who can and cannot join are on ClinicalTrials.gov. Your study doctor will review these requirements with you.

Study ID

More information available at ClinicalTrials.gov: NCT07218926