Actively Recruiting
Safety and Efficacy of NEO212 in Patients With Astrocytoma IDH-mutant, Glioblastoma IDH-wildtype or Brain Metastasis
Led by Neonc Technologies, Inc. · Updated on 2026-03-02
134
Participants Needed
6
Research Sites
199 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official 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 is 18 years of age or older.
- Ability to understand and willing to sign informed consent.
- Stable or decreasing steroid dose for at least 5 days before consent.
- Toxicity from prior therapy resolved or at maximum Grade 1.
- If disease progressed within 90 days of radiation, confirmed outside radiation field or via biopsy/resection.
- Karnofsky Performance Status of 60 or higher for Astrocytoma IDH-mutant or Glioblastoma IDH-wildtype patients.
- ECOG performance status of 0-2 for patients with select solid tumors.
- Expected survival of at least 3 months.
- Baseline brain MRI with gadolinium within 14 days before starting NEO212.
- Baseline CT scans of neck, chest, abdomen, and pelvis with contrast within 14 days before starting NEO212 for select solid tumor patients.
- Ability to comply with all study assessments.
- If seizures present, controlled on stable anti-epileptic dose for 14 days before consent.
- Adequate organ and marrow function (specific blood counts and liver/kidney function levels).
- Agreement to use adequate contraception for females of child-bearing potential and males before, during, and after study.
- Negative pregnancy test within 7 days before starting NEO212 for females of child-bearing potential.
- For Phase 1: radiographically confirmed Astrocytoma IDH-mutant, Glioblastoma IDH-wildtype after prior treatment 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, receiving approved SOC regimens.
- For Phase 2b: similar to Phase 1 and Phase 2a requirements with measurable disease and adequate kidney function.
You will not qualify if you...
- Receiving any other antitumor therapy concurrently in Phase 1.
- Receiving any Standard of Care therapy not listed in the study during Phase 2a or 2b.
- Metastases to spinal cord parenchyma or meninges.
- Received stereotactic or highly conformal radiotherapy to CNS lesions within 2 weeks before starting NEO212.
- History of leptomeningeal involvement.
- Secondary cancer diagnosed within 5 years except certain skin cancers.
- QTcF interval over 470 msec or history of risk factors for certain heart rhythms.
- Surgery within 7 days before consent.
- Not recovered to Grade 1 from prior treatment-related adverse events.
- Prior treatment with or allergic reaction to perillyl alcohol.
- More than one recurrence or progression of primary CNS tumor for Phase 2b patients with Astrocytoma IDH-mutant or Glioblastoma IDH-wildtype.
AI-Screening
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Trial Site Locations
Total: 6 locations
1
Precision NextGen Oncology
Beverly Hills, California, United States, 90212
Actively Recruiting
2
OPN Healthcare, Inc
Glendale, California, United States, 91203
Actively Recruiting
3
University of Southern California
Los Angeles, California, United States, 90033
Actively Recruiting
4
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
Actively Recruiting
5
Baylor, Scott and White Research Institute
Dallas, Texas, United States, 75246
Actively Recruiting
6
Northwest Medical Specialties
Tacoma, Washington, United States, 98405
Actively Recruiting
Research Team
C
Christopher Beardmore
CONTACT
C
Chloe Richmond
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
8
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