The first participant has begun and continues on therapy in a phase 1/2 clinical trial (NCT03965494) assessing bemcentinib (BGB324; Bergenbio, Norway) in recurrent glioblastoma (GBM). The trial is sponsored by professor Ichiro Nakano, MD, professor in the Department of Neurosurgery and coleader of the Neuro-Oncology Program at University of Alabama at Birmingham and funded by the National Cancer Institute (NCI).
Increased expression of the receptor tyrosine kinase AXL is significantly correlated with poor prognosis in GBM patients and preclinical data suggests bemcentinib may be a promising therapeutic agent for GBM, particularly postirradiation mesenchymal-transformed GBM. A comprehensive translational research program will run in parallel with the clinical trial; this will be conducted by professor Jeff Supko, Harvard Medical School and director of the Clinical Pharmacology Laboratory, Massachusetts General Hospital (Boston, USA).
This is an open label multicenter intratumoral tissue pharmacokinetic (PK) study of bemcentinib in participants with recurrent glioblastoma for whom a surgical resection is medically indicated. The study will enroll up to 20 recurrent GBM participants, at up to 15 sites in the US. There will be 10 participants treated prior to surgery and 10 participants will have no presurgical treatment. However, all participants will receive treatment with bemcentinib following surgery. The endpoints of the study include an evaluation of bemcentinib's ability to cross the blood brain barrier, AXL expression, pharmacokinetics, safety and tolerability, as well as efficacy assessments including progression free survival and overall survival.
Richard Godfrey, chief executive officer of BerGenBio, commented: "We congratulate professor Nakano and professor Nabors on the start of this exciting clinical study, which we believe will provide us with important data regarding the ability of bemcentinib to cross the blood-brain barrier and potentially treat GBM patients. This clinical trial is based on pioneering preclinical research carried out by our collaborators, conducted at high profile research hospitals in the US and is funded by National Cancer Institute (NCI). We look forward to reporting the potential of bemcentinib to improve patient outcomes in this very aggressive cancer."
Peter McAllister, MD
Fabio Fieni Toso, MD; Rene de Araújo Gleizer, MD; and Lívia Almeida Dutra, MD, PhD
Jason A. Ellis, MD; Benjamin W. Y. Lo, MD; Chirag G. Bhatia, BS; Yona Feit; Steven Mandel, MD; and Dana Shani, MD