Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
NEO100 · 2 trials · 9 indications
Progression free survival
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
| Arm | Type | Description |
|---|---|---|
| Patients with high-grade meningioma | EXPERIMENTAL | 30 patients with residual high-grade meningioma following resection surgery, radiographically-confirmed progression of high-grade meningioma or recurrent high-grade meningioma |
| Phase 1b safety, dose finding, brain-tumor delivery, and pharmacokinetics of IN NEO100 | 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. |
| Name | Type | Description |
|---|---|---|
| NEO100 | DRUG | NEO100 is a purified form of perillyl alcohol. |
Inclusion Criteria Patient must: 1. Have histologically confirmed WHO Grade II or III meningioma that is residual, progressive or recurrent following at least minimally safe resection and radiation therapy. Metastatic meningiomas are allowed. 1. Residual disease is defined as residual measurab...
NEO100 is an investigational small molecule being studied for the treatment of residual, progressive or recurrent Grade II or III meningioma and pediatric tumors of the central nervous system. It is being developed by NeOnc Technologies Holdings, Inc. and is currently in clinical trials for these oncology indications.
NEO100 is a small molecule therapeutic being developed by NeOnc Technologies Holdings, Inc. for oncology indications. The specific molecular target of NEO100 has not been disclosed in the available clinical trial information. It is currently being studied in patients with meningioma and pediatric brain tumors.
NEO100 is being developed by NeOnc Technologies Holdings, Inc., a biopharmaceutical company. The company is conducting clinical trials to evaluate NEO100 for the treatment of meningioma and pediatric central nervous system tumors. NeOnc Technologies Holdings, Inc. is the sponsor of the ongoing studies.
NEO100 is in Phase 1 and Phase 2 clinical development. A Phase 2 trial is recruiting patients with residual, progressive or recurrent Grade II or III meningioma, and a Phase 1 study is planned for pediatric brain tumors. NEO100 has received FDA designations including orphan drug, fast track, and rare pediatric disease.
NEO100 is being studied in two clinical trials. NCT05023018 is a Phase 2 study in patients with residual, progressive or recurrent Grade II or III meningioma, currently recruiting in the United States. NCT06357377 is a Phase 1 study planned for pediatric brain tumors, including diffuse midline glioma and high grade glioma.
NEO100 is an investigational drug being developed by NeOnc Technologies Holdings, Inc. for the treatment of meningioma and pediatric central nervous system tumors. It is currently in Phase 1 and Phase 2 clinical trials and has received FDA orphan drug, fast track, and rare pediatric disease designations.