Trial · NCT06357377
A Study of the Safety, Dosing, and Delivery of NEO100 in Patients With Pediatric Brain Tumors
NCT06357377, Phase 1, Recruiting, Neonc Technologies, Inc.
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study of the Safety, Dosing, and Delivery of NEO100 in Patients With Pediatric Brain Tumors. Trials, record NCT06357377. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06357377
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of the Safety, Dosing, and Delivery of NEO100 in Patients With Pediatric Brain Tumors
- NCT number
- NCT06357377
- Status
- Recruiting
- Phases
- Phase 1
- Enrollment
- 12 participants, estimated
- Lead sponsor
- Neonc Technologies, Inc.
- 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
- NEO100
- First posted
- 2024-04-10
- Last updated
- 2026-09-15
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Nature and severity of adverse events | 6 months | 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 |
| Secondary | Identify the maximum tolerated dose (MTD) of NEO100 | 6 months | Assess the maximum tolerated dose (MTD) of intranasally administered NEO100 using the NCI CTCAE (version 5.0) for reporting of non-hematologic AEs |
| Secondary | Determine the recommended Phase 2 dose (RP2D) of NEO100 | 6 months | Assess the maximum tolerated dose (MTD) of intranasally administered NEO100 using the NCI CTCAE (version 5.0) for reporting of non-hematologic AEs |
| Secondary | Measurement of NEO100 and its metabolite perillic acid in brain tumor tissue | 6 months | 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). |
| Secondary | Blood brain barrier penetration | 6 months | To confirm blood brain barrier (BBB) penetration of NEO100 by measuring the concentration of NEO100 and its metabolite in resected tumor tissue. |
| Secondary | Characterize the pharmacokinetics (PK) of NEO100 as measured by Peak Plasma Concentration | 6 months | Pharmacokinetic parameters of NEO100 metabolite perillic acid in the resected tumor tissue as measured by peak plasma concentration (Cmax). |
| Secondary | Characterize the pharmacokinetics (PK) of NEO100 as measured by the Time to Peak Plasma Concentration | 6 months | Pharmacokinetic parameters of NEO100 metabolite perillic acid in the resected tumor tissue as measured by the time to peak plasma concentration (Tmax). |
| Secondary | Characterize the pharmacokinetics (PK) of NEO100 as measured by Area Under the Curve | 6 months | 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). |
| Secondary | To assess efficacy of NEO100 based on objective response rate (ORR). | 6 months | Objective CNS tumor response to NEO100 as determined by RANO 2.0 criteria. |
| Secondary | To assess efficacy of NEO100 based on progression free survival (PFS). | 6 months | Progression free survival (PFS). |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT06357377
GET https://conductscience.org/api/trials/v1/NCT06357377/registered