This article has been updated to note the correct phase of the study being conducted.
NEW YORK – Phoenix-based Ivy Brain Tumor Center, part of the Barrow Neurological Institute, Tuesday announced that the first patient has received QED Therapeutics' infigratinib in a Phase 0 clinical trial investigating the drug in high-grade gliomas driven by FGFR genetic alterations.
The investigator-initiated study will evaluate whether infigratinib, an FGFR inhibitor developed by BridgeBio Pharma subsidiary QED Therapeutics, is able to cross the blood-brain barrier to target tumors with FGFR-TACC3 fusions, or FGFR1 and FGFR3 mutations.
Within the Phase 0 trial, roughly 20 patients with confirmed FGFR alterations in previously resected tumor samples will receive the oral agent. Patients who experience successful tumor penetration within days of treatment exposure will then continue to receive infigratinib as part of a Phase II expansion cohort. During the expansion phase, the investigators will assess six-month progression-free survival rates, as well as the effects of infigratinib on the molecular targets in each patients' tumor.
A previous, uncontrolled Phase II study of infigratinib in high-grade gliomas yielded intriguing yet inconclusive results. This latest trial "seeks to provide direct biological evidence of drug effects in individual patients, allowing us to understand which glioblastoma patients may benefit from infigratinib," Nader Sanai, director of the Ivy Brain Tumor Center, said in a statement.
Infigratinib is also being evaluated in other solid tumors with FGFR alterations, including urothelial cancer and advanced bile duct cancer. For the latter indication, QED Therapeutics has received fast-track designation from the US Food and Drug Administration and intends to submit a new drug application this year.
"The launch of this investigator-initiated trial is an exciting step in the study of infigratinib for patients with recurrent, high-grade glioma," QED Chief Medical Officer Susan Moran said in a statement. "We anticipate this study being conducted by the Ivy Center will generate valuable information on the ability of infigratinib to reach brain tumors, which is a critical first step in evaluating whether infigratinib, alone or in combination, could potentially provide a therapeutic option for patients with this dire disease."