The Global Coalition for Adaptive Research (GCAR) and Purdue Pharma L.P. have announced the initiation of Phase 2 studies evaluating investigational tinostamustine within the GBM AGILE (Glioblastoma Adaptive Global Innovative Learning Environment; NCT03970447) platform trial. GBM AGILE is an international, adaptive clinical trial framework developed to expedite identification of effective treatments for glioblastoma (GBM), the most aggressive form of primary brain cancer.
Tinostamustine will be studied in adult patients with newly diagnosed GBM across all participating GBM AGILE sites and in a separate cohort of patients with recurrent disease at select locations. The seamless Phase 2/3 trial operates under a master protocol, enabling evaluation of multiple therapies or combinations from different sponsors against a common control arm. Data generated through GBM AGILE may serve as the foundation for future regulatory submissions.
Since the program’s inception in 2019, GBM AGILE has screened more than 2,600 patients at approximately 60 sites in six countries. Dr. John de Groot of the University of California, San Francisco, and Dr. Shiao-Pei Weathers of the University of Texas MD Anderson Cancer Center serve as Principal Investigators for tinostamustine’s arm, while Dr. Timothy Cloughesy of UCLA oversees the global study.
Tinostamustine is a first-in-class compound that combines bifunctional DNA alkylating activity with pan histone deacetylase (HDAC) inhibition. The agent is being investigated for potential use in both newly diagnosed and recurrent GBM, addressing a critical unmet need in glioblastoma treatment.
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