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

StatusRecruiting
PhasePhase 1
Started2026-09-08
View on ClinicalTrials.gov ↗
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).

Amendment history 3 changes detected by DataLookout

2026-09-16
Recruitment opened
2026-09-16
Primary completion pushed: 2026-10 → 2027-06
2026-09-16
Completion pushed: 2026-10 → 2027-07
Trial Details
NCT Number NCT06357377
Lead Sponsor Neonc Technologies, Inc.
Conditions Pediatric Tumor of CNS, Pediatric Tumor of Brain, Diffuse Midline Glioma, H3 K27M-Mutant, Pediatric Tumor of Brain Stem, Pineocytoma, Choroid Plexus Carcinoma, Childhood, Spinal Cord Tumor, High Grade Glioma
Enrollment 12 participants
Start Date 2026-09-08
Primary Completion 2027-06 (estimated)
Study Completion 2027-07 (estimated)
Updated on ClinicalTrials.gov 2026-09-15