Phase 1/2 NEO212 for Astrocytoma, Glioblastoma, or Brain Metastases
This study is testing a new oral capsule called NEO212, alone or with other approved cancer medicines like Ipilimumab, Pembrolizumab, Nivolumab, or Regorafenib. It's for adults with certain types of astrocytoma (a type of brain tumor), glioblastoma (an aggressive brain cancer), or other cancers that have spread to the brain (brain metastases). The main goals for the first part of the study are to find a safe dose of NEO212 and see how well it's tolerated over 6 months. This study will also look at how effective NEO212 is in treating these conditions. You might be able to join if you are 18 or older and have stable or decreasing steroid use for at least five days before starting the study.
- Study design
- This is a multi-site, open-label study with three phases (Phase 1, 2a, and 2b) and plans to enroll up to 134 participants. Phase 1 will involve increasing doses of NEO212 to find the safest and most effective dose.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary endpoints for Phase 1 are measured at 6 months, suggesting follow-up for at least that duration.
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NCT06047379
Safety and Efficacy of NEO212 in Patients With Astrocytoma IDH-mutant, Glioblastoma IDH-wildtype or Brain Metastasis
Recruiting
PHASE1Ages 18+InterventionalTreatmentNeonc Technologies, Inc.
~134 participants
Updated 2026-07-16 on ClinicalTrials.gov
What's tested:NEO212 Oral CapsuleIpilimumabPembrolizumabNivolumabRegorafenibCarboplatin
At a glance
Recruiting sites
7 of 7 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
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
Measured over 6 months
+5 more outcomes measured
Conditions
Where it's being run
7 sites across 5 statesCalifornia3
Florida1
Tennessee1
Texas1
Washington1
Study leadership
- Tom Chen, MD, PhD · STUDY_CHAIR · NeOnc Technologies
- Josh Neman, PhD · STUDY_DIRECTOR · NeOnc Technologies Holdings, Inc.
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
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 solid tumors must have a baseline CT scan with IV contrast and oral contrast of neck, chest, abdomen and pelvis within 14 days of administration of NEO212.
Patients must be able to comply with all study assessments.
If patient suffers from seizures (s)he must be controlled on a stable dose of anti-epileptics for 14-days prior to the date of informed consent.
Patient must have adequate organ and marrow function as follows:
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).
Female patients of child-bearing potential and male patients must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) for 30 days prior to the first dose of NEO212, for the duration of study participation, and for 90 days following completion of therapy.
Has not undergone a hysterectomy or bilateral oophorectomy; or
Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has not had menses at any time in the preceding 12 consecutive months).
A negative serum pregnancy test will be required of all female patients of child-bearing potential within seven days prior to the receipt of NEO212.
A serum pregnancy test will be repeated immediately if pregnancy is suspected.
Patient must:
have radiographically confirmed Astrocytoma IDH-mutant, Glioblastoma IDH-wildtype following previous radiation therapy or treatment with temozolomide and radiation, or
have select solid tumors with uncontrolled metastases to the brain (confirmed by cranial CT or MRI) that is not controlled by surgery or radiation therapy and receiving one of the protocol approved SOC regimens.
Patients receiving prior systemic therapy must have a minimum wash-out period (defined as the period prior to receipt of the first dose of NEO212) of:
28 days or 5 half-lives (whichever is shorter) elapsed from the administration from any experimental agent;
2 weeks from administration of immunotherapies;
28 days from administration of cytotoxic agents; and
7 days from administration of non-cytotoxic agents (interferon, tamoxifen, thalidomide, cis-retinoic acid, and herbal medicine).
Patient must have select solid tumors with uncontrolled metastases to the brain (confirmed by cranial CT or MRI) that is not controlled by surgery or radiation therapy and receiving one of the protocol approved SOC regimens.
Patients receiving prior systemic therapy must be receiving one of the protocol approved Standard of Care (SOC) regimens.
Patient must have measurable/evaluable CNS disease per RANO or RANO-BM criteria.
Patient must have measurable/evaluable systemic disease per RECIST v1.1 criteria.
Patient must:
have radiographically confirmed Astrocytoma IDH-mutant, Glioblastoma IDH-wildtype following previous radiation therapy or treatment with temozolomide and radiation, or
have select solid tumors with uncontrolled metastases to the brain (confirmed by cranial CT or MRI) that is not controlled by surgery or radiation therapy and receiving one of the protocol approved SOC regimens.
Patients receiving prior systemic therapy must be receiving one of the protocol approved Standard of Care (SOC) regimens.
Patient must have measurable/evaluable CNS disease per RANO or RANO-BM criteria
Patient with select solid tumors must have measurable/evaluable systemic disease per RECIST v1.1 criteria.
Creatinine clearance (CrCl) of \>60 mL/min (using the Cockcroft-Gault formula or 24-hour urine collection). Female patients of child-bearing potential and male patients must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) for 30 days prior to the first dose of NEO212, for the duration of study participation, and for 90 days following completion of therapy.
Exclusion
Patient in Phase 1 concurrently receiving any other antitumor therapy.
Patient in Phase 2a or 2b who is concurrently receiving any SOC therapy not listed in Appendix 1.
Patients with metastases to the spinal cord parenchyma.
Patients with metastases to the meninges.
Patient has received stereotactic or highly conformal radiotherapy to CNS lesions within 2 weeks before receipt of NEO212.
Patient with history of known leptomeningeal involvement.
Patient has prior history or new diagnosis of secondary cancer within five years prior to the date of informed consent, except for basal cell carcinoma or squamous cell carcinoma of the skin.
Patient has a corrected QT interval (using Fridericia's correction formula) (QTcF) of \>470 msec, a history of additional risk factors for TdP (e.g. heart failure, hypokalemia), and/or the use of concomitant medications that prolong QT/QTc interval.
Patient had surgery within 7 days prior to the date of informed consent.
Patient has not recovered to Grade 1 from treatment related adverse events due to chemotherapy, immunotherapy, or radiation therapy.
Patient had prior treatment with perillyl alcohol.
Patient has a history of allergic reactions attributed to perillyl alcohol.
Patients in Phase 2b with Astrocytoma IDH-mutant, or Glioblastoma IDH-wildtype who have had more than one recurrence or progression of his/her primary CNS tumor(s).
What this trial 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 brain6 months
As determined by incidence and severity of adverse events according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE v5.0
- Phase 1: Identify the maximum tolerated dose (MTD) of NEO2126 months
Maximum Tolerated Dose of NEO212 as determined by the dose escalation rules.
- Phase 1: Determine the recommended Phase 2 dose (RP2D) of NEO2126 months
Determine the recommended Phase 2 dose (RP2D) of NEO212
- 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 brain6 months
Determined by incidence and severity of adverse events determined according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE v5.0).
- 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
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.
- 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
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 (see Appendix 2) with uncontrolled metastases to the brain.