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Life sciences · Phase 1/2 Trial
ClinicalTrials.gov · September 15, 2026
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Phase 1/2 Trial.
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Registry record from ClinicalTrials.gov (NCT06047379). This is a study registration, not published results. Lead sponsor: Neonc Technologies, Inc.. Recruitment status: RECRUITING. Phase: PHASE1, PHASE2. Study type: INTERVENTIONAL. Enrollment: 134 participants (ESTIMATED). 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; DRUG: Ipilimumab; DRUG: Pembrolizumab; DRUG: Nivolumab; DRUG: Regorafenib; DRUG: Carboplatin; DRUG: Paclitaxel; DRUG: FOLFIRI Protocol; DRUG: Bevacizumab. Primary outcome measures: Phase 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 , 6 months; Phase 1: Identify the maximum tolerated dose (MTD) of NEO212 , 6 months; Phase 1: Determine the recommended Phase 2 dose (RP2D) of NEO212 , 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 , 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. , 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. , 6 months. 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.