The Global Coalition for Adaptive Research (GCAR) and Purdue Pharma have announced the activation of tinostamustine in the Glioblastoma Adaptive Global Innovative Learning Environment (GBM AGILE) clinical trial.
The trial focuses on both newly diagnosed and recurrent cases, aiming to accelerate the identification of effective treatments for adult GBM patients.
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It is a Phase II/III study that uses a master protocol to simultaneously evaluate multiple treatments or therapy combinations from different pharmaceutical companies with a shared control arm.
With operational efficiency, the trial can generate data potentially supporting new drug applications and registrations with the US Food and Drug Administration (FDA) and other health authorities.
Since 2019, GBM AGILE has evaluated several investigational therapies and screened more than 2,600 patients at around 60 sites across six countries.
University of California, San Francisco neuro-oncology division chief Dr John de Groot and University of Texas MD Anderson Cancer Center’s neuro-oncology brain tumour section chief Dr Shiao-Pei Weathers are leading the evaluation of tinostamustine.
University of California, Los Angeles neuro-oncology programme director Dr Timothy Cloughesy is the global principal investigator.
GBM is the most common and aggressive primary brain cancer.
Tinostamustine is a first-in-class chemical entity that merges bifunctional DNA alkylating activity, which induces apoptosis, with pan-histone deacetylase (HDAC) inhibition, disrupting oncogenic pathways and increasing immune detection of tumour cells.
This dual-action approach may be relevant to aggressive and treatment-resistant GBM.
Purdue president and CEO Dr Craig Landau said: “Activation of the first trial sites represents the culmination of years of hard work and dedication, scientific rigour, and partnership. It underscores our determination to apply sustained scientific and clinical investment to help deliver new treatments patients urgently need.”
