A Phase 3, Multicenter, Clinical Study to Evaluate the Efficacy and Safety of Safusidenib Erbumine in Participants With Isocitrate Dehydrogenase 1 (IDH1)-Mutant Glioma

This study is testing a new medication called safusidenib to see if it can help people with a specific type of brain tumor called an IDH1-mutant glioma. By targeting this specific genetic mutation, researchers hope to slow down or stop the tumor from growing.

This study is for adults 18 or older who have been diagnosed with an IDH1-mutant glioma that has returned or continued to grow after previous treatments. To participate, your specific genetic mutation must be confirmed by a lab, and you must meet certain health requirements regarding recent surgeries or other cancer therapies.

Depending on which part of the study you join, you may receive either the test medication or a placebo, which is an inactive pill that looks like the real treatment. You will be closely monitored by your care team to see how you respond to the treatment and to ensure your safety throughout the process.

This study is currently recruiting participants and is taking place at multiple medical locations, including sites in Birmingham, Alabama, and Phoenix, Arizona.