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Safety and Efficacy of NEO212 in Patients With Astrocytoma IDH-mutant, Glioblastoma IDH-wildtype or Brain Metastasis

StatusRecruiting
PhasePhase 1/2
Started2023-11-01
View on ClinicalTrials.gov ↗
This multi-site, Phase 1/2 clinical trial is an open-label study to identify the safety, pharmacokinetics, and efficacy of a repeated dose regimen of NEO212 alone for the treatment of patients with radiographically-confirmed progression of Astrocytoma IDH- mutant, Glioblastoma IDH-wildtype, and the safety, pharmacokinetics and efficacy of a repeated dose regimen of NEO212 when given with select SOC for the treatment of solid tumor patients with radiographically confirmed uncontrolled metastases to the brain. The study will have three phases, Phase 1, Phase 2a and Phase 2b.

Amendment record

Amended 10 times since 2023-09-18; most recent filed 2026-07-15. Every amendment is listed below.

Dates here are the day the sponsor filed the amendment, not the day ClinicalTrials.gov published it. Version history last read from ClinicalTrials.gov on 2026-08-30.

2026-07-15
Amendment Study Status, Contacts/Locations v10
2026-02-27
Amendment Study Status, Contacts/Locations v9
2026-01-13
Amendment Study Status, Eligibility v8
2026-01-07
Amendment Study Status, Study Description, Eligibility, Contacts/Locations v7
2025-12-18
Amendment Study Identification, Study Status, Oversight, Contacts/Locations, IPDSharing v6
2024-10-11
Amendment Study Identification, Study Status, Oversight, Study Description, Eligibility, Contacts/Locations, IPDSharing v5
2024-02-13
Amendment Study Status, Eligibility v4
2024-01-04
Amendment Study Status, Contacts/Locations v3
2023-11-29
Amendment Not Yet Recruiting→Recruiting Study Status, Eligibility, Contacts/Locations v2
2023-10-18
Amendment Study Status v1
2023-09-18
Original filing
Trial Details
NCT Number NCT06047379
Lead Sponsor Neonc Technologies, Inc.
Conditions Diffuse Astrocytoma, IDH-Mutant, Glioblastoma, IDH-wildtype, Brain Metastases, Adult, Cervical Cancer, Colorectal Cancer, Esophageal Cancer, Esophageal Squamous Cell Carcinoma, Gastric Cancer +13 more
Enrollment 134 participants
Start Date 2023-11-01
Primary Completion 2027-02-28 (estimated)
Study Completion 2027-08-31 (estimated)
Updated on ClinicalTrials.gov 2026-09-15