Clinical Trial

AZD1390 in Recurrent and Newly Diagnosed WHO Grade 4 Glioma Patients

Active, Not Recruiting Early Phase 1
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Record status
This record was last updated March 9, 2026 (before its estimated June 10, 2026 completion). Its status may not reflect the trial's current state.
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).
Protocol Amendment History 6 amendments
This ClinicalTrials.gov record has been amended 6 times since 2021-12-22; most recent amendment 2026-03-05.
Status change: Recruiting → Active, Not Recruiting 2026-03-05
Status change: Not Yet Recruiting → Recruiting 2022-03-10
Trial Details
NCT Number NCT05182905
Lead Sponsor Nader Sanai
Collaborators: Barrow Neurological Institute, Ivy Brain Tumor Center, AstraZeneca
Conditions Glioblastoma, Glioma, Glioblastoma Multiforme, Glioma, Malignant
Enrollment 97 participants
Start Date 2022-05-27
Primary Completion 2026-06-10 (estimated)
Study Completion 2026-12-10 (estimated)
Updated on ClinicalTrials.gov 2026-03-09