drugset / Trial / NCT07389278

Combination ADI-PEG 20, TMZ, and RT for Treatment of Newly Diagnosed High-grade Glioma (HGG)

NCT07389278

Phase 1/2 Not yet recruiting 97 enrolled Sabine Mueller, MD, PhD
Non-randomizedSequentialOpen-labelTreatment

Summary

This is an open label, intra-patient dose escalation, to evaluate ADI-PEG 20, in combination with Temozolomide (TMZ) and radiation therapy (RT) in children, adolescents and young adult patients with newly diagnosed high grade glioma (HGG).

Timeline

Start
2026-03-09
Primary completion
2032-06-30
Completion
2035-06-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Pegargiminase Protein / enzyme biologic 36 mg/m2 Intramuscular
Background Temozolomide Small molecule Oral