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

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).

Trial Details

NCT ID
NCT06357377
Phase
PHASE1
Sponsor
Neonc Technologies, Inc.
Status
RECRUITING
Cancer Type
Brain Cancer
Interventions
  • NEO100
Locations (sample)
  • Orange, California, United States|33.78779,-117.85311

Key Eligibility Criteria

  • Patient must have radiographically confirmed, newly diagnosed or recurrent pediatric-type high grade glioma: Diffuse Midline Glioma, H3 K27-altered…
  • Karnofsky ≥ 50 for patients \> 16 years of age or Lansky ≥ 50 for patients ≤ 16 years of age. Participants who are unable to walk because of paraly…
  • If clinically indicated, participants must be willing to provide adequate tissue for PK analysis, either from a surgical biopsy or needle biopsy.
  • Aged ≥5 to ≤18 years.

For full eligibility, visit ClinicalTrials.gov.

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