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

Phase 1/2 Recruiting 134 enrolled Neonc Technologies, Inc.

Non-randomizedParallel-groupOpen-labelTreatment

Summary

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.

Timeline

Start: 2023-11-01
Primary completion: 2027-02-28
Completion: 2027-08-31

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Bevacizumab	Monoclonal antibody	10 mg/kg	Intravenous
Subject	Carboplatin	Small molecule	300 mg/m2	Intravenous
Subject	Ipilimumab	Monoclonal antibody	3 mg/kg	Intravenous
Subject	Irinotecan	Small molecule	—	—
Subject	Leucovorin	Small molecule	—	—
Subject	NEO212	Unknown	170 mg	Oral
Subject	NEO212	Unknown	220 mg	Oral
Subject	NEO212	Unknown	400 mg	Oral
Subject	NEO212	Unknown	610 mg	Oral
Subject	NEO212	Unknown	810 mg	Oral
Subject	NEO212	Unknown	1000 mg	Oral
Subject	Nivolumab	Monoclonal antibody	240 mg	—
Subject	Paclitaxel	Small molecule	135 mg/m2	Intravenous
Subject	Pembrolizumab	Monoclonal antibody	200 mg	Intravenous
Subject	Regorafenib	Small molecule	160 mg	Oral
Subject	fluorouracil	Small molecule	—	—

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

Summary

Timeline

Drugs

Indications