Clinical Research Directory

A Study of SRN-101 Gene Therapy in Adults With Recurrent High-Grade Glioma (ALERT-1)

ALERT-1 is a Phase 1/2 study evaluating the safety and preliminary anti-tumor activity of SRN-101, an investigational gene therapy, in adults with recurrent high-grade glioma. High-grade glioma is a type of brain cancer. This study is for adults whose cancer has returned for the first time and for whom surgical removal of the tumor is not planned. SRN-101 uses an adeno-associated virus (AAV) to deliver a gene for human interferon beta, a protein within the tumor. The safety and effectiveness of SRN-101 in this setting have not been established. Each participant will receive one infusion of SRN-101 directly into the brain tumor during an MRI-guided procedure. The study will first evaluate different dose levels and then evaluate a selected dose in additional participants. Participants will have MRI scans, blood tests and other health assessments, and follow-up visits to assess safety and changes in their cancer.