drugset / Trial / NCT07464925

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

NCT07464925 ↗

Phase 1 Recruiting 30 enrolled Tetragon Biosciences Ltd
NaSequentialOpen-labelTreatment

Summary

This is an open-label, multicenter dose-escalation study to be followed by a dose expansion to define the optimal dose of GLIX1 as monotherapy by reviewing safety and tolerability, disease characteristics and pharmacokinetic profiles and preliminary clinical activity in participants with a high grade diffuse glioma that progressed during or recurred after prior standard of care therapies or investigational therapies as clinically indicated. Patients will be treated daily with GLIX1 capsules until disease progression or unacceptable safety.

Timeline

Start
2026-04-20
Primary completion
2027-06
Completion
2027-12

Drugs

EvaluationDrugModalityDoseRoute
Subject GLIX1 Small molecule 1000 mg Oral

Indications