Ignite Creation Date:
2024-05-06 @ 8:22 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06357377
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-10
First Post:
2024-03-13
Brief Title:
A Study of the Safety Dosing and Delivery of NEO100 in Patients with Pediatric Brain Tumors
Sponsor:
Neonc Technologies Inc
Organization:
Neonc Technologies Inc
Study Overview
Official Title:
An Open Label Phase 1b Safety Dose-finding Brain Tumor Delivery and Pharmacokinetics Study of Intranasal NEO100 in Patients with Pediatric-type Select Brain Tumors
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 resectionneedle 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
Detailed Description:
NEO100 drug product is a non-sterile solution for intranasal administration
A feature of the clinical trials of NEO100 is to investigate the efficacy of this drug when it is delivered intranasally Based on the general body of data on intranasal drug delivery as well as the promising results from clinical studies in which perillyl alcohol was delivered intranasally NeOnc expects that intranasal administration of NEO100 will allow rapid and more selective delivery of therapeutic levels of the drug to the brain while minimizing systemic toxicity and first pass metabolism
The study is a dose titration 11 design with a modified Fibonacci dose escalation followed by a expansion design used to determine the maximum tolerated dose and to select a recommended Phase 2 dose RP2D The starting dose of 192 mg mgdose administered QID on a 28-day cycle is one dose below the safe dose administered to adults in a Phase 12a study Dosing will increase using a modified Fibonacci dose escalation The daily dose will start at 768 mgday and rise to 1152 mgday which is also the safe dose administered to adults in a Phase 12a study
The study is open to patient with Pediatric-type high grade glioma Newly diagnosed and recurrent Diffuse Midline Glioma H3 K27-altered Diffuse hemispheric glioma H3 G34-mutant grade III and IV diffuse pediatric-type HGG H3-wildtype and IDH-wildtype including spinal cord tumors Recurrent malignant tumors involving the brainstem or posterior fossa choroid plexus carcinoma CNS embryonal tumors and pineoblastoma
A feature of the clinical trials of NEO100 is to investigate the efficacy of this drug when it is delivered intranasally Based on the general body of data on intranasal drug delivery as well as the promising results from clinical studies in which perillyl alcohol was delivered intranasally NeOnc expects that intranasal administration of NEO100 will allow rapid and more selective delivery of therapeutic levels of the drug to the brain while minimizing systemic toxicity and first pass metabolism
The study is a dose titration 11 design with a modified Fibonacci dose escalation followed by a expansion design used to determine the maximum tolerated dose and to select a recommended Phase 2 dose RP2D The starting dose of 192 mg mgdose administered QID on a 28-day cycle is one dose below the safe dose administered to adults in a Phase 12a study Dosing will increase using a modified Fibonacci dose escalation The daily dose will start at 768 mgday and rise to 1152 mgday which is also the safe dose administered to adults in a Phase 12a study
The study is open to patient with Pediatric-type high grade glioma Newly diagnosed and recurrent Diffuse Midline Glioma H3 K27-altered Diffuse hemispheric glioma H3 G34-mutant grade III and IV diffuse pediatric-type HGG H3-wildtype and IDH-wildtype including spinal cord tumors Recurrent malignant tumors involving the brainstem or posterior fossa choroid plexus carcinoma CNS embryonal tumors and pineoblastoma
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None