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NCT ID: NCT06357377 Not yet recruiting - High Grade Glioma Clinical Trials

A Study of the Safety, Dosing, and Delivery of NEO100 in Patients With Pediatric Brain Tumors

Start date: May 1, 2024
Phase: Phase 1
Study type: Interventional

This is an open label, Phase 1b safety, dose-finding, brain tumor delivery, and pharmacokinetics study of intranasal NEO100 in patients with pediatric-type diffuse high grade gliomas. Patients will receive IN NEO100 that will follow a dose titration design, followed by a standard dose escalation design to establish safety. Brain tumor delivery of NEO100 will be confirmed in each disease sub-type by surgical resection/needle biopsy only if clinically indicated and scheduled for clinical purposes and testing with residual tissue for NEO100 and the major metabolite of NEO100 (Perillic Acid).