OncoMatch/Clinical Trials/NCT06047379
Safety and Efficacy of NEO212 in Patients With Astrocytoma IDH-mutant, Glioblastoma IDH-wildtype or Brain Metastasis
Is NCT06047379 recruiting? Yes, currently enrolling (Jun 2026). This Phase 1/2 trial studies multiple treatments for diffuse astrocytoma, idh-mutant.
Treatment: NEO212 Oral Capsule · Ipilimumab · Pembrolizumab · Nivolumab · Regorafenib · Carboplatin · Paclitaxel · FOLFIRI Protocol · Bevacizumab — 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Immunotherapy
Targeted therapy
Chemotherapy
Other
Cancer type
Glioblastoma
Cervical Cancer
Colorectal Cancer
Esophageal Carcinoma
Gastric Cancer
Head and Neck Squamous Cell Carcinoma
Melanoma
Tumor Agnostic
Non-Small Cell Lung Carcinoma
Renal Cell Carcinoma
Small Cell Lung Cancer
Urothelial Carcinoma
Biomarker criteria
Required: IDH1 mutation
Required: IDH1 wild-type
Prior therapy
Must have received: radiation therapy
following previous radiation therapy or treatment with temozolomide and radiation
Cannot have received: perillyl alcohol
prior treatment with perillyl alcohol
Lab requirements
Blood counts
Absolute neutrophil count ≥ 1,500/microliter; Platelets ≥ 100,000/microliter
Kidney function
Creatinine clearance (CrCl) of >60 mL/min (using the Cockcroft-Gault formula or 24-hour urine collection)
Liver function
Total bilirubin within normal institutional limits; AST (SGOT) / ALT (SPGT) ≤ 2.5 x institutional upper limit of normal
Cardiac function
QTcF ≤ 470 msec, no history of additional risk factors for TdP (e.g. heart failure, hypokalemia), and/or the use of concomitant medications that prolong QT/QTc interval
Absolute neutrophil count ≥ 1,500/microliter; Platelets ≥ 100,000/microliter; Total bilirubin within normal institutional limits; AST (SGOT) / ALT (SPGT) ≤ 2.5 x institutional upper limit of normal; Creatinine clearance (CrCl) of >60 mL/min (using the Cockcroft-Gault formula or 24-hour urine collection); QTcF ≤ 470 msec, no history of additional risk factors for TdP (e.g. heart failure, hypokalemia), and/or the use of concomitant medications that prolong QT/QTc interval
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Precision NextGen Oncology · Beverly Hills, California
- OPN Healthcare, Inc · Glendale, California
- University of Southern California · Los Angeles, California
- Vanderbilt University Medical Center · Nashville, Tennessee
- Baylor, Scott and White Research Institute · Dallas, Texas
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT06047379 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior perillyl alcohol disqualifies patients from enrollment.
Does this trial require IDH1?
Yes, IDH1 mutation is a required biomarker for enrollment.
Does this trial require IDH1?
Yes, IDH1 wild-type is a required biomarker for enrollment.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
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