Phase 1 Study to Find the Safe Dose of Oral GLIX1 for Adults With Recurrent or Progressive High-grade Glioma

What this Trial Is About

Researchers are evaluating GLIX1, an oral small molecule drug, in adults with recurrent or progressive high-grade glioma, a type of aggressive brain tumor that often recurs after standard treatments. This open-label Phase 1 study aims to find the optimal dose by assessing safety, tolerability, disease characteristics, pharmacokinetics, and preliminary clinical activity. High-grade gliomas are challenging to treat and have limited options after progression, making this research important for exploring new therapies. Participants will receive escalating doses of GLIX1 capsules daily, starting at 1000 mg per day, taken orally in cycles of 28 days. The study includes a dose-escalation phase followed by a dose expansion phase to refine the best dose. Treatment will continue until disease progression or unacceptable side effects occur. GLIX1 works by enhancing an enzyme TET2 that leads to DNA damage in cancer cells, potentially causing cancer cell death. During the study, participants will be monitored closely with safety evaluations, including tracking treatment-emergent adverse events from the first dose until 30 days after the last dose. Researchers will assess the maximal tolerated dose and recommended dose after each 28-day cycle. Participants will undergo regular assessments such as MRI scans, blood tests, and clinical evaluations to monitor disease status and safety. The total study duration extends until 2027, with primary outcome data expected by mid-2027.

A Phase 1 Safety and Dose Finding Study of GLIX1 in Adults With Recurrent or Progressive High-grade Glioma