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

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 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 brain metastasis. The study will have three phases, Phase 1, Phase 2a and Phase 2b.

本项多中心Ⅰ/Ⅱ期开放标签临床试验，旨在评估NEO212重复给药方案治疗经影像学证实进展的IDH突变型星形细胞瘤、IDH野生型胶质母细胞瘤患者的安全性、药代动力学与疗效；同时评估NEO212联合选定标准治疗（Standard of Care, SOC）的重复给药方案，治疗经影像学证实存在未控脑转移的实体瘤患者的安全性、药代动力学与疗效。本试验分为三个阶段：Ⅰ期、Ⅱa期及Ⅱb期。