The data generated by the trial could be potentially used for BLA and NDA submissions to the US FDA and other health regulators. Credit: PeopleImages.com – Yuri A/Shutterstock.

The Global Coalition for Adaptive Research (GCAR) has executed an agreement to evaluate AstraZeneca‘s AZD1390 compound in the ‘Glioblastoma Adaptive Global Innovative Learning Environment’ (GBM AGILE) trial.

This global adaptive platform trial’s design, which includes response adaptive randomisation and a Phase II/III trial structure, aims to expedite the identification and confirmation of effective therapies for glioblastoma patients.

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The AZD1390 group of the trial is set to focus on the treatment of newly diagnosed glioblastoma patients and recruitment is anticipated to commence by the second quarter of next year.

Conceived by more than 130 key opinion leaders, GBM AGILE operates under a master protocol, which allows for the concurrent evaluation of several treatments against a common control arm.

The data generated by this trial could be potentially used for submitting a biologics license application (BLA) and new drug application (NDA) to the US Food and Drug Administration (FDA) and other health regulators.

GCAR CEO and president Dr Meredith Buxton said: “GCAR is committed to accelerating the development of life-changing treatments for patients with rare and deadly diseases such as glioblastoma. We believe that adaptive platform trials have the potential to achieve that mission and make a profound difference for patients.

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“We are delighted to collaborate with AstraZeneca and look forward to expediting the evaluation of AZD1390 in GBM AGILE for the treatment of glioblastoma, a devastating disease with a critical need for more effective treatments.”

Professor Anthony Chalmers from the University of Glasgow and Dr Patrick Wen from Dana-Farber Cancer Institute and Harvard Medical School will serve as principal investigators for the AZD1390 arm.

Dr Timothy Cloughesy from the University of California, Los Angeles, will act as the global principal investigator for the entire study.

Since its inception in July 2019, GBM AGILE has screened more than 2,000 subjects across six countries and has assessed multiple therapies.

A brain-penetrant ataxia telangiectasia mutant (ATM) kinase inhibitor, AZD1390 impedes ATM-dependent signalling and repair of deoxyribonucleic acid (DNA) double-strand breaks (DSBs) in the genome.

In November 2023, GCAR partnered with Cure Brain Cancer Foundation (CBCF) to introduce the GBM AGILE trial in Australia.