NEO100 for Pediatric Brain Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
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).
Who Is on the Research Team?
Josh Neman, PhD
Principal Investigator
NeOnc Technologies Holdings, Inc.
Thomas Chen, MD, PhD
Principal Investigator
NeOnc Technologies Holdings, Inc.
Are You a Good Fit for This Trial?
This trial is for children and young adults with certain aggressive brain or spinal tumors, including newly diagnosed or recurrent high-grade gliomas. Participants must be well enough to care for themselves (or use a wheelchair), have recovered from previous treatments, and meet specific blood count requirements.Inclusion Criteria
What Are the Treatments Tested in This Trial?
Interventions
- NEO100
Trial Overview
The study tests the safety and best dose of NEO100 given through the nose in kids with high-grade brain tumors. It uses increasing doses to find what’s safe, while monitoring how the drug moves in the body. Tumor samples may be tested if surgery is already planned.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
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). The study will use a modified Fibonacci dose titration design, followed by a standard dose escalation design. * Cohort 1: 192 mg NEO100, QID on a 28-day cycle * Cohort 2: 288 mg NEO100, QID on a 28-day cycle * Cohort 3: 384 mg NEO100, TID on a 28-day cycle; * Cohort 4 (ceiling dose): 576 mg NEO100, BID on a 28-day cycle. Patients undergoing surgical or needle biopsy (only when clinically indicated) will receive a minimum of four days IN NEO100 treatment prior to the procedure.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Neonc Technologies, Inc.
Lead Sponsor
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