NCT03423628

A Study to Assess the Safety and Tolerability of AZD1390 Given With Radiation Therapy in Patients With Brain Cancer

Recruiting now Phase 1 Last updated 22 December 2025

What this trial tests

Phase 1 trial testing Radiation Therapy in Recurrent Glioblastoma Multiforme in 180 participants. Currently enrolling.

Timeline

2 April 2018

Primary endpoint
16 September 2026

16 September 2026

Quick facts

Lead sponsor	AstraZeneca
Phase	Phase 1
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	180
Start date	2 April 2018
Primary completion	16 September 2026
Estimated completion	16 September 2026
Sites	12 locations across United Kingdom, Japan, United States

Drugs / interventions tested

• Radiation Therapy — full drug profile →
• AZD1390 — full drug profile →
• Radiation Therapy — full drug profile →
• Radiation Therapy — full drug profile →
• AZD1390 — full drug profile →
• AZD1390 — full drug profile →

Conditions studied

• Recurrent Glioblastoma Multiforme — all drugs for Recurrent Glioblastoma Multiforme →
• Primary Glioblastoma Multiforme — all drugs for Primary Glioblastoma Multiforme →
• Brain Neoplasms, Malignant — all drugs for Brain Neoplasms, Malignant →
• Leptomeningeal Disease (LMD) — all drugs for Leptomeningeal Disease (LMD) →

Sponsor

AstraZeneca — full company profile →

Who can join

Adults 18 to 130, any sex, with Recurrent Glioblastoma Multiforme or Primary Glioblastoma Multiforme. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This study will test an investigational drug called AZD1390 in combination with radiation therapy for the treatment of brain tumors. This is the first time AZD1390 is being given to patients. This study will test safety, tolerability and PK (how the drug is absorbed, distributed and eliminated) of ascending doses of AZD1390 in combination with distinct regimens of radiation therapy

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Glioblastoma in adults: a Society for Neuro-Oncology (SNO) and European Society of Neuro-Oncology (EANO) consensus review on current management and future directions.
   Wen PY, Weller M, Lee EQ, Alexander BM, et al · · 2020 · cited 908× · PMID 32328653 · DOI 10.1093/neuonc/noaa106
2. Current Challenges and Opportunities in Treating Glioblastoma.
   Shergalis A, Bankhead A, Luesakul U, Muangsin N, et al · · 2018 · cited 612× · PMID 29669750 · DOI 10.1124/pr.117.014944
3. Tumor biomarkers for diagnosis, prognosis and targeted therapy.
   Zhou Y, Tao L, Qiu J, Xu J, et al · · 2024 · cited 379× · PMID 38763973 · DOI 10.1038/s41392-024-01823-2
4. DNA Repair Pathways in Cancer Therapy and Resistance.
   Li LY, Guan YD, Chen XS, Yang JM, et al · · 2020 · cited 254× · PMID 33628188 · DOI 10.3389/fphar.2020.629266
5. The brain-penetrant clinical ATM inhibitor AZD1390 radiosensitizes and improves survival of preclinical brain tumor models.
   Durant ST, Zheng L, Wang Y, Chen K, et al · · 2018 · cited 236× · PMID 29938225 · DOI 10.1126/sciadv.aat1719
6. ATM inhibition enhances cancer immunotherapy by promoting mtDNA leakage and cGAS/STING activation.
   Hu M, Zhou M, Bao X, Pan D, et al · · 2021 · cited 203× · PMID 33290271 · DOI 10.1172/jci139333
7. Treatment strategies for breast cancer brain metastases.
   Bailleux C, Eberst L, Bachelot T. · · 2021 · cited 170× · PMID 33250512 · DOI 10.1038/s41416-020-01175-y
8. Radiation-induced tumor immune microenvironments and potential targets for combination therapy.
   Guo S, Yao Y, Tang Y, Xin Z, et al · · 2023 · cited 136× · PMID 37208386 · DOI 10.1038/s41392-023-01462-z