Actively Recruiting
An Open-label Phase 12 Study of Oral NEO212 for Astrocytoma IDH-mutant, Glioblastoma IDH-wildtype, or Uncontrolled Brain Metastases in Select Solid Tumors
Led by Neonc Technologies, Inc. · Updated on 2026-03-02
134
Participants Needed
6
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, pharmacokinetics, and efficacy of a repeated dose regimen of NEO212 in patients with Astrocytoma IDH-mutant, Glioblastoma IDH-wildtype, and patients with select solid tumors that have uncontrolled metastases to the brain. This open-label, multi-site Phase 12 trial includes dose escalation and combination with standard of care treatments to address progression confirmed by imaging. The study is divided into three phases to determine safe doses and assess treatment effects.
CONDITIONS
Brief Title
Safety and Efficacy of NEO212 in Patients With Astrocytoma IDH-mutant, Glioblastoma IDH-wildtype or Brain Metastasis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient must be 18 years of age or older.
- Ability and willingness to sign written informed consent.
- Stable or decreasing steroid dose for at least five days before consent.
- Toxicity from prior therapy resolved or at maximum Grade 1 before starting NEO212.
- For progression within 90 days of radiation, progression must be outside radiation field or biopsy-proven.
- Karnofsky Performance Status of 60 or higher for Astrocytoma and Glioblastoma patients.
- ECOG performance status of 0 to 2 for select solid tumor patients.
- Expected survival of at least three months.
- Baseline brain MRI with gadolinium within 14 days before NEO212.
- Baseline CT scan with contrast of neck, chest, abdomen, and pelvis within 14 days before NEO212 for select solid tumors.
- Ability to comply with all study assessments.
- Stable anti-epileptic dose for 14 days prior if seizures present.
- Adequate organ and marrow function as defined by specified blood counts and labs.
- Use of adequate contraception for females of child-bearing potential and males during and after study.
- Negative pregnancy test for females of child-bearing potential within seven days before NEO212.
- For Phase 1: confirmed progression of Astrocytoma or Glioblastoma after radiation or standard therapy, or select solid tumors with uncontrolled brain metastases receiving approved SOC regimens.
- Required washout periods from prior therapies before starting NEO212.
- For Phase 2a: measurable CNS and systemic disease and receiving approved SOC regimens.
- For Phase 2b: confirmed progression of Astrocytoma or Glioblastoma or select solid tumors with brain metastases, measurable disease, and receiving approved SOC regimens.
- Creatinine clearance over 60 mL/min using standard methods.
You will not qualify if you...
- Receiving other antitumor therapy concurrently in Phase 1.
- Receiving any SOC therapy not listed in the protocol during Phase 2a or 2b.
- Metastases to the spinal cord parenchyma or meninges.
- Received stereotactic or highly conformal radiotherapy to CNS lesions within 2 weeks before NEO212.
- Known leptomeningeal involvement.
- History or new diagnosis of secondary cancer within five years except certain skin cancers.
- Corrected QT interval over 470 msec or risk factors for heart rhythm problems.
- Surgery within 7 days before consent.
- Not recovered to Grade 1 from treatment-related adverse events.
- Prior treatment with perillyl alcohol or allergic reaction to it.
- More than one recurrence or progression of primary CNS tumor in Phase 2b Astrocytoma or Glioblastoma patients.
Research Team
C
Christopher Beardmore
C
Chloe Richmond
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