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AZD1390 in Recurrent and Newly Diagnosed WHO Grade 4 Glioma Patients

NCT05182905 · Status: ACTIVE_NOT_RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 97

Last updated 2026-03-09

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • Barrow Neurological Institute

    collaborator OTHER

  • Ivy Brain Tumor Center

    collaborator OTHER

  • AstraZeneca

    collaborator INDUSTRY

  • Nader Sanai

    lead OTHER

Principal Investigators

  • Nader Sanai, MD · Chief Scientific Officer/Director

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-05-27
Primary Completion
2026-06-10
Completion
2026-12-10
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05182905 on ClinicalTrials.gov