NCT06829173

Concurrent XRD-0394 With Radiation Therapy for High Grade Gliomas

A Phase 0/I Study to Assess the Safety and Tolerability of XRD-0394 in Combination With Radiation Therapy in Patients With High Grade Gliomas

• Status: Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 39 (estimated)
• Sponsor: NYU Langone Health · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is an open-label, dose-finding study of XRD-0394 in subjects with newly diagnosed and recurrent high grade gliomas receiving radiation therapy, with and without concurrent temozolomide based on O6-Methylguanine-DNA methyltransferase (MGMT) status for patients with newly diagnosed high grade gliomas.

Conditions

• High-Grade Glioma

Interventions

Type	Name	Description
DRUG	XRD-0394	Administered orally; small molecule dual inhibitor of ataxia telangiectasia mutated kinase (ATM) and DNA-PK.
RADIATION	Radiation Therapy	For Cohort A and Cohort B, the neoadjuvant "boost" radiation dose is 1400cGy delivered over 7 fractions, and the adjuvant radiation dose is 5000cGy delivered over 25 fractions for a total dose of 6400cGy over 32 fractions, accounting for the treatment break between boost and adjuvant RT. For Cohort C, the radiation dose is 3500cGy delivered over 10 fractions.
PROCEDURE	Surgical Resection	Resection of tumor tissue.

Timeline

• Start date: 2025-11-05
• Primary completion: 2027-05-01
• Completion: 2031-05-01
• First posted: 2025-02-17
• Last updated: 2026-01-02

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study