Safety and Efficacy of NEO212 in Patients With Astrocytoma IDH-mutant, Glioblastoma IDH-wildtype or Brain Metastasis
← catalyst calendarNCT06047379 · readout in 193 d
Sponsored by Neonc Technologies, Inc. (industry) · NTHI — their whole pipeline →.
Phase
Phase 1/2
Status
Recruiting
Study type
Interventional
Design
Non randomized · None · Treatment
Enrollment
134estimated
Sites
7
Country
United States
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2023-11-01 | actual | When the study began enrolling |
| Primary completion | 2027-02-28 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2027-08-31 | estimated | The whole study's end, after follow-up |
| First posted | 2023-09-21 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-07-16 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Conditions
- Diffuse Astrocytoma, IDH-Mutant
- Glioblastoma, IDH-wildtype
- Brain Metastases, Adult
- Cervical Cancer
- Colorectal Cancer
- Esophageal Cancer
- Esophageal Squamous Cell Carcinoma
- Gastric Cancer
- Gastroesophageal Junction Adenocarcinoma
- Head and Neck Squamous Cell Carcinoma
- Melanoma
- Merkel Cell Carcinoma
- Microsatellite Instability-High Solid Malignant Tumor
- Mismatch Repair Deficient Solid Malignant Tumor
- Microsatellite Instability-High Colorectal Cancer
- Mismatch Repair Deficient Colorectal Cancer
- Non-small Cell Lung Cancer
- Renal Cell Carcinoma
- Small Cell Lung Cancer
- Squamous Cell Carcinoma
- Urothelial Carcinoma
Interventions
- Drug: NEO212 Oral Capsule — also filed as POH-TMZ
- Drug: Ipilimumab — also filed as Yervoy
- Drug: Pembrolizumab — also filed as Keytruda
- Drug: Nivolumab — also filed as Opdivo
- Drug: Regorafenib — also filed as Stivagra
- Drug: Carboplatin — also filed as Paraplatin
- Drug: Paclitaxel — also filed as Taxol
- Drug: FOLFIRI Protocol — also filed as Zaltrap
- Drug: Bevacizumab — also filed as Avastin, Mvasi, Zirabev, Alymsys, Vegzelma
Primary outcomes
what the primary-completion date above is the date OFPhase 1: safety and tolerability of increasing dose levels of orally administered NEO212 alone in patients with Astrocytoma IDH-mutant, Glioblastoma IDH-wildtype or patients with select solid tumors with uncontrolled metastases to the brain
measured 6 months
Phase 1: Identify the maximum tolerated dose (MTD) of NEO212
measured 6 months
Phase 1: Determine the recommended Phase 2 dose (RP2D) of NEO212
measured 6 months
Phase 2a: Assess the safety and tolerability of orally administered NEO212 in combination with select SOC regimens following a standard 3+3 design in patients with select solid tumors with uncontrolled metastases to the brain
measured 6 months
Phase 2b: Determine the intracranial progression-free survival rate at six months (PFS6) of orally administered NEO212 alone in patients with Astrocytoma IDH-mutant, Glioblastoma IDH-wildtype.
measured 6 months
Phase 2b: Determine the intracranial progression-free survival rate at six months (PFS6) of orally administered NEO212 in combination with select SOC regimens in patients with select solid tumors with uncontrolled metastases to the brain.
measured 6 months
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