Evaluating NRG-103 Injection Safety and Early Effectiveness in Adults with Recurrent or Progressive High-grade Glioma

What this Trial Is About

Researchers are evaluating the safety, tolerability, and early effectiveness of NRG-103 injection in adults with recurrent or progressive high-grade glioma, specifically WHO Grade 3 or 4 glioma. This Phase 1 study aims to determine the safe dose range of NRG-103 and recommend dosing for future treatment while assessing preliminary efficacy and tolerability. Participants will receive NRG-103, an investigational drug given as an injection. The study is designed as a single-group trial without placebo or comparator arms. Patients eligible for this study have exhausted standard anti-tumor therapies or cannot tolerate them and show evidence of tumor recurrence or progression confirmed by MRI or surgical biopsy. Treatment dosing and schedules will be monitored over time. During the study, participants will have various assessments including MRI scans to evaluate tumor progression, safety monitoring for adverse events over two years, and evaluation of dose-limiting toxicities over eight weeks. Researchers will track progression-free survival at six months as a secondary outcome. The study will continue until April 2030, with participants involved in regular visits for safety and efficacy evaluations throughout the treatment period.

A Clinical Trial Evaluating the Tolerability, Safety, and Preliminary Efficacy of NRG-103 Injection in Patients With Recurrent or Progressive High-grade Glioma