On July 28, 2020 Ivy Brain Tumor Center at Barrow Neurological Institute reported that the first patient has been dosed in an investigator-initiated Phase 0/2 clinical trial of infigratinib in recurrent high-grade glioma driven by FGFR genetic alterations (Press release, BridgeBio, JUL 28, 2020, View Source [SID1234576226]). Infigratinib is an investigational, orally administered, FGFR1-3 selective tyrosine kinase inhibitor being developed by BridgeBio Pharma, Inc. (Nasdaq: BBIO) affiliate company QED Therapeutics, Inc.
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The investigator-initiated Phase 0/2 trial is designed to confirm drug effects within days of exposure, and only to continue dosing when the drug is active in a patient’s own tumor. The primary objective of the Phase 0 arm is to assess how effectively infigratinib can cross the blood-brain barrier – the most significant obstacle to developing new, effective therapies for aggressive brain tumors like glioblastoma. Patients with successful tumor penetration will receive infigratinib long-term in a Phase 2 expansion arm of the trial. The primary endpoint of the expansion phase is progression-free survival rate at six months. The study will also measure how well infigratinib is impacting its molecular target in each patient’s tumor.
FGFR (fibroblast growth factor receptor) genetic alterations have been shown to spur growth in malignant tumors. Five to seven percent of glioblastoma patients’ tumors are driven by FGFR signaling. During the trial screening process, the patient’s tumor tissue from prior surgery will be tested for the FGFR-TACC3 fusion gene or mutations in FGFR1 and FGFR3 genes. Patients with tumors that have these fusions or mutations are eligible for this study.
"In the preclinical studies, our pharmacokinetics program at the Ivy Brain Tumor Center tested seven FGFR inhibitors for their ability to cross the blood-brain barrier. Infigratinib was one of the most promising agents," said Shwetal Mehta, Ph.D., deputy director of the Ivy Brain Tumor Center.
"Infigratinib was previously tested in an uncontrolled Phase 2 study for recurrent high-grade gliomas," said Nader Sanai, M.D., director of the Ivy Brain Tumor Center. "The results were intriguing, but inconclusive. This Ivy Phase 0/2 trial seeks to provide direct biological evidence of drug effects in individual patients, allowing us to understand which glioblastoma patients may benefit from infigratinib."
"The launch of this investigator-initiated trial is an exciting step in the study of infigratinib for patients with recurrent, high-grade glioma," said Susan Moran, M.D., M.S.C.E., chief medical officer of QED Therapeutics. "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."