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tozuleristide 24 or 36 mg administered intravenously 1-24 hours prior to surgery

tozuleristide

imaging device attached to surgical microscope

Canvas imaging system

Standard of care surgical resection of tumor

Surgical resection of tumor

Clinical Trial Navigator

Ray Chu, MD

Chirag Patil, MD

Jeremy Rudnick, MD

Jethro Hu, MD

Serguei Bannykh, MD, PhD

John Yu, MD

The purpose of this study is to examine the use of a single dose of tozuleristide (24 or 36 mg) and the Canvas imaging system during surgical resection of primary central nervous system (CNS) tumors: Primary gadolinium enhancing (high grade) CNS tumors, primary non-gadolinium enhancing CNS tumors, and primary vestibular schwannoma.

The primary objectives of the study is to see how well tozuleristide and the Canvas imaging system during surgical resection will show fluorescence among primary enhancing/high grade CNS tumors; and among the tumors that demonstrate tozuleristide fluorescence, to estimate the true positive rate and true negative rate of fluorescence in tissue biopsies, as well as sensitivity and specificity of tozuleristide fluorescence for distinguishing tumor from non-tumoral tissue.

The secondary objectives of the study include evaluating the safety of tozuleristide and the Canvas imaging system, and to determine if the presence of remaining fluorescence at the time of surgery corresponds to remaining tumor evident on post-operative MRI images, or if the absence of fluorescence corresponds to evidence of no gross residual tumor on post-operative magnetic resonance imaging (MRI).

Fluorescence Detection of Adult Primary Central Nervous System Tumors With Tozuleristide and the Canvas System

A Phase 2 Study of Fluorescence Detection of Adult Primary Central Nervous System Tumors in Subjects Receiving Tozuleristide and Imaged With the Canvas System

Recorded and graded according to the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 5

Blaze Bioscience Inc.

John Yu

Director, Surgical Neuro-Oncology

Carcinoma

Brain Stem Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neoplasms, Neuroepithelial

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms, Nerve Tissue

Brain Diseases

Central Nervous System Diseases

Spinal Cord Diseases

Choroid Plexus Carcinoma

Brain Tumor, Childhood

Neuroepithelioma

Anti-Infective Agents

Central Nervous System Depressants

All Drugs and Chemicals

Pharmaceutical Solutions

Antineoplastic Agents

Other Dietary Supplements

Ethanol

Perillyl alcohol

Glycerol

Enzyme Inhibitors

Perillyl Alcohol

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.

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.

NEO100

Chris Beardmore

Chloe Richmond

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).

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 1+1 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 mg/dose administered QID, on a 28-day cycle, is one dose below the safe dose administered to adults in a Phase 1/2a study. Dosing will increase using a modified Fibonacci dose escalation. The daily dose will start at 768 mg/day, and rise to 1,152 mg/day, which is also the safe dose administered to adults in a Phase 1/2a 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 Study of the Safety, Dosing, and Delivery of NEO100 in Patients With Pediatric Brain Tumors

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

Assess the safety and tolerability of increasing dose levels of intranasally administered NEO100 using the NCI CTCAE (version 5.0) for reporting of non-hematologic AEs

Assess the maximum tolerated dose (MTD) of intranasally administered NEO100 using the NCI CTCAE (version 5.0) for reporting of non-hematologic AEs

Confirm brain tumor delivery by measuring levels of NEO100 (POH) and its metabolite perillic acid (PA) in postsurgical tumor tissue in patients with pediatric-type brain tumors (measured in ng/mg).

To confirm blood brain barrier (BBB) penetration of NEO100 by measuring the concentration of NEO100 and its metabolite in resected tumor tissue.

Pharmacokinetic parameters of NEO100 metabolite perillic acid in the resected tumor tissue as measured by peak plasma concentration (Cmax).

Pharmacokinetic parameters of NEO100 metabolite perillic acid in the resected tumor tissue as measured by the time to peak plasma concentration (Tmax).

Pharmacokinetic parameters of NEO100 metabolite perillic acid in the resected tumor tissue as measured by the area under the plasma concentration vs time curve (AUC).

Objective CNS tumor response to NEO100 as determined by RANO 2.0 criteria.

Neonc Technologies, Inc.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Fluorescence Detection of Adult Primary Central Nervous System Tumors With Tozuleristide and the Canvas System	NCT04743310	Central Nervous...	tozuleristide Canvas imaging ... Surgical resect...	18 Years -	Cedars-Sinai Medical Center
A Study of the Safety, Dosing, and Delivery of NEO100 in Patients With Pediatric Brain Tumors	NCT06357377	Pediatric Tumor... Pediatric Tumor... Diffuse Midline... Pediatric Tumor... Pineocytoma Choroid Plexus ... Spinal Cord Tum... High Grade Glio...	NEO100	5 Years - 18 Years	Neonc Technologies, Inc.
Fluorescence Detection of Adult Primary Central Nervous System Tumors With Tozuleristide and the Canvas System	NCT04743310	Central Nervous...	tozuleristide Canvas imaging ... Surgical resect...	18 Years -	Cedars-Sinai Medical Center

Spots Global Cancer Trial Database for pineocytoma

Every month we try and update this database with for pineocytoma cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for pineocytoma

Every month we try and update this database with for pineocytoma cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for pineocytoma cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.