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Intranasal NEO100 for Pediatric Brain Tumors

Study Aim

This study aims to evaluate the safety and tolerability of increasing doses of intranasal NEO100 in children with brain tumors by observing any adverse events.

What is being tested

NEO100

Drug

Who is being recruted

Brain Diseases+15

+ Brain Neoplasms

+ Central Nervous System Diseases

From 5 to 18 Years

+35 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Phase 1

Interventional

Study Start: January 2026

See protocol details

Summary

Principal SponsorNeonc Technologies, Inc.

Study ContactChris BeardmoreMore contacts

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: January 1, 2026

Actual date on which the first participant was enrolled.

This study aims to explore the safety and effectiveness of a drug called NEO100, designed for children with specific types of brain tumors. These tumors include newly diagnosed or recurrent forms of high-grade glioma and other malignant brain-related tumors. The study focuses on delivering NEO100 through the nose, which is believed to help the drug reach the brain more quickly and effectively while reducing side effects. This research is important because it may lead to better treatment options for children facing these challenging conditions, offering a way to target the tumor directly and potentially improve outcomes. Participants in the study will receive NEO100 through nasal administration. The study starts with a lower dose and gradually increases it to find the safest and most effective amount. The initial dose is set at 192 mg, given four times a day in a 28-day cycle, and can be increased based on how well participants tolerate it. Researchers will monitor participants closely to evaluate any side effects and to determine how well the drug is delivered to the brain. The ultimate goal is to identify the best dose for future studies while ensuring the safety of all participants.

Official TitleAn Open Label, Phase 1b Safety, Dose-finding, Brain Tumor Delivery, and Pharmacokinetics Study of Intranasal NEO100 in Patients With Pediatric-type Select Brain Tumors

NCT06357377

Principal SponsorNeonc Technologies, Inc.

Study ContactChris BeardmoreMore contacts

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

12 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 5 to 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Brain DiseasesBrain NeoplasmsCentral Nervous System DiseasesGliomaNeoplasmsNeoplasms by Histologic TypeNeoplasms by SiteNeoplasms, Germ Cell and EmbryonalNeoplasms, Glandular and EpithelialNeoplasms, Nerve TissueNervous System DiseasesNervous System NeoplasmsPinealomaSpinal Cord DiseasesSpinal Cord NeoplasmsCentral Nervous System NeoplasmsNeuroectodermal TumorsNeoplasms, Neuroepithelial

Criteria

21 inclusion criteria required to participate

Bilirubin (sum of conjugated + unconjugated) ≤ 1.5 x upper limit of normal (ULN) for age.

No evidence of dyspnea at rest, no exercise intolerance due to pulmonary insufficiency, and a pulse oximetry of > 92% while breathing room air.

Aged ≥5 to ≤18 years.

Prior use of temozolomide during radiation at maximum of the standard pediatric dosing (defined as 90 mg/m2 /dose continuously during radiation therapy for 42 days) or dexamethasone is allowed.

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14 exclusion criteria prevent from participating

Active illicit drug use or diagnosis of alcoholism.

Participants who are currently receiving other anti-cancer agents.

Known additional malignancy that is progressing or requires active treatment within 3 years of start of study drug.

History of allergic reactions attributed to compounds of similar chemical or biologic composition as the agents used in study.

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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group

Treatment Groups

Group I

Experimental

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.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

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