GBM AGILE is a large, international Phase 2/3 trial for newly diagnosed and recurrent glioblastoma. It has an innovative adaptive design that allows multiple experimental therapies to be tested at the same time against a shared control arm to more efficiently identify promising treatments. We have a Musella Foundation recorded webinar about the trial available HERE.
GBM AGILE is now adding a new study arm for Tinostamustine, an investigational drug that combines DNA-alkylating activity (to damage tumor DNA and trigger cell death) with HDAC inhibition (an epigenetic mechanism that may increase tumor sensitivity and immune recognition). Earlier phase 1 studies showed the drug has a manageable safety profile.