Safety and Efficacy of NEO212 in Patients With Astrocytoma IDH-mutant, Glioblastoma IDH-wildtype or Brain Metastasis
Trial Parameters
Brief 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.
Eligibility Criteria
Inclusion Criteria: * Patient must be ≥ 18yrs of age. * Patient must have the ability to understand, and the willingness to sign, a written informed consent form. * Patient has been on a stable or decreasing dose of steroids for at least five days prior to the date of informed consent. * Any toxicity from prior therapy must be resolved or at maximum Grade 1 prior to initiation of NEO212. * If progression of disease occurs within 90 days or conformal radiation, the progression/recurrence must be outside of the radiation field or proven by biopsy/resection. * Patient with Astrocytoma IDH-mutant, Glioblastoma IDH-wildtype must have a Karnofsky Performance Status (KPS) of ≥ 60. * Patient with select solid tumors must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2. * Patient must have an expected survival or at least three months. * Patient must have a baseline MRI of the brain with gadolinium within 14 days of administration of NEO212. * Patient with select sol