GCAR and AstraZeneca Reach Agreement to Evaluate AZD1390 in Phase II/III Clinical Trial

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The Global Coalition for Adaptive Research (GCAR) and AstraZeneca have reached an agreement to evaluate AstraZeneca’s compound, AZD1390, in the GBM AGILE trial (Glioblastoma Adaptive Global Innovative Learning Environment, NCT03970447). AZD1390 will be evaluated in patients with newly diagnosed glioblastoma, with recruitment expected to begin by Q2 2025.¹

GBM AGILE is the world’s first global adaptive platform trial for glioblastoma. It is designed to identify and confirm effective therapies for patients with glioblastoma through response adaptive randomization. With a Phase II/III design, the trial is conducted under a master protocol, allowing multiple therapies or combinations of therapies from different pharmaceutical companies to be evaluated simultaneously against a common control arm.

According to GCAR, Professor Anthony Chalmers, chair of clinical oncology at the University of Glasgow and Patrick Wen, MD, director, Center for Neuro-Oncology at Dana-Farber Cancer Institute, and Professor of Neurology at Harvard Medical School, will serve as principal investigators for the AZD1390 arm. Timothy Cloughesy, MD, director, Neuro-Oncology Program and Distinguished Professor of Neurology at the University of California, Los Angeles, is the global principal investigator for the overall GBM AGILE study.

In a press release, Wen said, “There is an urgent need for new, tolerable and effective therapies to treat glioblastoma. GBM AGILE is a revolutionary, patient-centered, potentially registration-enabling, adaptive platform trial for glioblastoma. We are excited to include AZD1390 in GBM AGILE, based on encouraging data from previous studies, showing encouraging preliminary efficacy in heavily treated recurrent glioblastoma patients and potential for AZD1390 to act as a radiosensitizer. This investigational drug has the potential to support improved outcomes for glioblastoma patients.”

AstraZeneca’s AZD1390 is brain penetrant ataxia telangiectasia mutant (ATM) kinase inhibitor that blocks ATM-dependent signaling and repair of DNA double strand breaks (DSBs) in the genome. Based on Phase I data presented at the American Association for Cancer Research (AACR) Annual Meeting 2024, AZD1390 alongside radiotherapy demonstrated a manageable safety profile and preliminary efficacy for patients with glioblastoma.

“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,” said Meredith Buxton, PhD, MPH, chief executive officer and president of GCAR in the press release. “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.”

The GBM AGILE trial was launched in July 2019. With trial locations in six countries, it has evaluated multiple therapies and has screened over 2000 patients since its inception.

Reference

1. Global Coalition for Adaptive Research Announces Evaluation of AZD1390 in GBM AGILE Trial. News release. Global Coalition for Adaptive Research. November 22, 2024. Accessed November 25, 2024. https://www.gcaresearch.org/news/global-coalition-for-adaptive-research-announces-evaluation-of-azd1390-in-gbm-agile-trial/