The Global Coalition for Adaptive Research (GCAR) has entered into an agreement to evaluate AstraZeneca's AZD1390 within the Glioblastoma Adaptive Global Innovative Learning Environment (GBM AGILE) trial, a global adaptive platform trial designed to expedite the identification of effective therapies for glioblastoma patients. The trial's design incorporates response adaptive randomization and a Phase II/III trial structure.
GBM AGILE Trial Details
The AZD1390 arm of the trial will focus on treating newly diagnosed glioblastoma patients, with recruitment expected to begin in the second quarter of next year. GBM AGILE, conceived by over 130 key opinion leaders, operates under a master protocol that allows for the concurrent evaluation of multiple treatments against a shared control arm. Data from the trial could potentially support biologics license application (BLA) and new drug application (NDA) submissions to the US Food and Drug Administration (FDA) and other regulatory bodies.
Expert Perspectives
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." 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
AZD1390 is a brain-penetrant ataxia telangiectasia mutant (ATM) kinase inhibitor. It functions by impeding ATM-dependent signaling and the 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 the Cure Brain Cancer Foundation (CBCF) to introduce the GBM AGILE trial in Australia.
