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

NCT06357377 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2026-01-14

No results posted yet for this study

Summary

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).

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

Interventions

DRUG

NEO100

NEO100 is a purified form (\>98.5%) of the naturally occurring monoterpene perillyl alcohol. NEO100 drug product is a non-sterile solution for intranasal administration. It is compounded as a 10% solution in a 50:50 mixture of ethanol:glycerol.

Sponsors & Collaborators

  • Neonc Technologies, Inc.

    lead INDUSTRY

Principal Investigators

  • Thomas Chen, MD, PhD · NeOnc Technologies Holdings, Inc.

  • Josh Neman, PhD · NeOnc Technologies Holdings, Inc.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
5 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-31
Primary Completion
2026-10-31
Completion
2026-10-31
FDA Drug
Yes

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06357377 on ClinicalTrials.gov