The Global Coalition for Adaptive Research (GCAR) and AstraZeneca have entered into an agreement to evaluate AstraZeneca's AZD1390 in the Glioblastoma Adaptive Global Innovative Learning Environment (GBM AGILE) trial. This trial is designed to expedite the identification and confirmation of effective therapies for glioblastoma patients through its adaptive platform design, which includes response adaptive randomization and a Phase II/III trial structure.
Trial Design and Focus
The AZD1390 arm of the trial will specifically focus on the treatment of newly diagnosed glioblastoma patients. Recruitment is expected to begin in the second quarter of next year. GBM AGILE, conceived by over 130 key opinion leaders, operates under a master protocol, enabling the concurrent evaluation of several treatments against a common control arm. Data from this trial could potentially support biologics license application (BLA) and new drug application (NDA) submissions to the US Food and Drug Administration (FDA) and other health regulators.
Expert Commentary
GCAR CEO and president Dr. Meredith Buxton stated, "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. 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.
AZD1390 Mechanism and GBM AGILE Progress
AZD1390 is a brain-penetrant ataxia telangiectasia mutant (ATM) kinase inhibitor, designed to impede ATM-dependent signaling and repair of deoxyribonucleic acid (DNA) double-strand breaks (DSBs) in the genome. Since its inception in July 2019, GBM AGILE has screened over 2,000 subjects across six countries and has assessed multiple therapies. In November 2023, GCAR partnered with Cure Brain Cancer Foundation (CBCF) to introduce the GBM AGILE trial in Australia.
