NCT05182905

AZD1390 in Recurrent and Newly Diagnosed WHO Grade 4 Glioma Patients

A Phase 0/1b, Single Center, Clinical Trial With an Expansion Phase of AZD1390 Plus Fractionated Radiotherapy in Recurrent and Newly Diagnosed WHO Grade 4 Glioma Patients

• Status: Active Not Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 97 (estimated)
• Sponsor: Nader Sanai · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is an open-label, single-center Phase 0/1b study that will enroll at least 27 participants with recurrent WHO Grade 4 Glioma requiring re-radiation and approximately 35 participants with newly-diagnosed WHO Grade 4 glioma (nGBM). The trial will be composed of a Phase 0 component (subdivided into Arms A - C), and an expansion Phase 1b. Patients with tumors demonstrating a positive PK response in the Phase 0 component of the study will be eligible to graduate to an expansion phase that combines therapeutic dosing of AZD1390 plus standard-of-care fractionated radiotherapy (RT).

Conditions

• Glioblastoma
• Glioma
• Glioblastoma Multiforme
• Glioma, Malignant

Interventions

Type	Name	Description
DRUG	AZD1390	Phase 0: AZD1390 administered orally daily for 3 days prior to resection Phase 1b: AZD1390 administered daily for 5 days concurrently with standard of care radiation therapy

Timeline

• Start date: 2022-05-27
• Primary completion: 2026-06-10
• Completion: 2026-12-10
• First posted: 2022-01-10
• Last updated: 2026-03-09

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study