AstraZeneca's AZD1390 Enters Cutting-Edge GBM AGILE Trial
In an important development for glioblastoma treatment, the Global Coalition for Adaptive Research (GCAR) has officially launched AstraZeneca's AZD1390 within the GBM AGILE (Glioblastoma Adaptive Global Innovative Learning Environment) trial, a groundbreaking global adaptive platform study.
This trial marks a significant milestone in glioblastoma research, focusing on a patient population that has historically had limited treatment options. The AGILE trial is the world’s first of its kind to adopt such an innovative adaptive approach, allowing for multiple investigational therapies to be evaluated concurrently against a unified control group.
What is GBM AGILE?
GBM AGILE is designed to streamline clinical trials for glioblastoma, a particularly aggressive form of brain cancer. Since its inception in 2019, the trial has already screened over 2,300 patients across six countries. Notably, AZD1390 is now the seventh investigational treatment included in this trial.
This seamless transition between phases 2 and 3 within the master protocol makes it uniquely flexible. By evaluating different therapies simultaneously, it aims to identify the most effective treatments in a faster timeframe, potentially leading to new drug applications with the FDA and other health authorities.
The Potential of AZD1390
AZD1390 is an innovative brain-penetrant ataxia telangiectasia mutated (ATM) kinase inhibitor. It works by disrupting ATM-dependent signaling pathways that are crucial for repairing DNA double-strand breaks (DSBs) in tumors. Preliminary data suggest that AZD1390 could enhance the efficacy of radiation therapy by preventing the cancer cells from effectively repairing their DNA damage caused by radiation.
Recent findings from phase 1 trials indicate a manageable toxicity profile and initial signs of effectiveness for patients experiencing recurrent glioblastoma, sparking optimism among researchers involved in the study.
Voices from the Director’s Chair
Professor Anthony Chalmers, Chair of Clinical Oncology at the University of Glasgow, emphasized the urgency of better treatment options for glioblastoma patients, noting, "Glioblastoma is an invariably fatal cancer with few effective treatment options. The need for better therapies is critical."
"We are excited to evaluate AZD1390 in GBM AGILE based on encouraging data from previous studies," he added, underlining the investigational drug's promise to enhance patient outcomes.
Similarly, Dr. Patrick Wen, Director of the Center for Neuro-Oncology at Dana-Farber Cancer Institute, highlighted GBM AGILE's unique approach to swiftly identify effective therapies through adaptive randomization. The trial's global reach ensures that patients can access cutting-edge therapies as soon as they become available.
GCAR's Vision
Dr. Meredith Buxton, CEO and President of GCAR, spoke passionately about their dedication to advancing treatment options for patients with rare and life-threatening diseases like glioblastoma. She stated, "At GCAR, we're committed to accelerating the development of critically needed therapies. Our collaboration with AstraZeneca plays an essential role in this mission."
As the trial unfolds, the impact of AZD1390 on glioblastoma treatment could herald a new era in cancer research, one that may address the urgent need for innovative and effective therapies. For more details on this vital research initiative, visit
GCAR’s website to learn about the collaborative efforts shaping the future of glioblastoma treatment.