ClinicalTrials.gg
RecruitingNCT06047379Updated Sep 24, 2026

Safety and Efficacy of NEO212 in Patients With Astrocytoma IDH-mutant, Glioblastoma IDH-wildtype or Brain Metastasis

A Phase 1/2 interventional study of NEO212 Oral Capsule and Ipilimumab in Diffuse Astrocytoma, IDH-Mutant, Glioblastoma, IDH-wildtype and Brain Metastases, Adult, sponsored by Neonc Technologies, Inc.. Recruiting at 8 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-24.

Primary conditionGlioblastomaRegistry: AstrocytomaReclassifiedWhy we changed it
Registry
Astrocytoma — the first condition term the registry derived for this study.
ClinicalTrials.gg
Glioblastoma
Why
  1. The study's listed conditions name Glioblastoma, a narrower term within Astrocytoma.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by Neonc Technologies, Inc. · Phase 1/2, Interventional, and Treatment

From the registry’s dates

  • Started Nov 2023; still recruiting 3 years later.
Phase
Phase 1/2
Study type
Interventional
Enrollment
134
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the detailed description

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 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 brain metastasis. The study will have three phases, Phase 1, Phase 2a and Phase 2b.

Phase 1 is a standard cohort dose escalation 3+3 design with a modified Fibonacci dose escalation used to determine the maximum tolerated dose to select a recommended Phase 2 dose (RP2D) of NEO212 for Phase 2a and Phase 2b. The initial dose of NEO212 will be 170 mg and the dose will increase in successive cohorts (220, 400, 610, 810, and 1,000 mg) until a MTD is reached and a RP2D is selected. There will be up to 42 patients enrolled in Phase 1. In the event two DLTs are experienced in any cohort, a dose de- escalation cohort will be followed (with half of the dose increase from the previous cohort) to determine the MTD/RP2D.

Phase 2a is a safety run-in study with a standard 3+3 design used to confirm the safety of the MTD/RP2D of NEO212 when given in combination with select SOC regimens for patients with uncontrolled metastases to the brain. There will be up to 12 patients enrolled into each combination regimen to confirm safety. One dose below the NEO212 MTD/RP2D Cohort Dose will be administered as a starting dose to establish safety (3+3), before moving to Phase 2b with the MTD/RP2D (3+3). In the event that two DLTs are experienced for patients receiving the MTD/RP2D in combination with SOC, the dose de-escalation cohort will be expanded to determine the MTD for a newly established Phase 2b Treatment Group.

Phase 2b is a dose expansion study to assess efficacy of NEO212 alone, at the MTD/RP2D in patients with Astrocytoma IDH-mutant, Glioblastoma IDH-wildtype as a single Treatment Group. A second Treatment Group to study the MTD/RP2D of NEO212 in combination with select SOC regimens in patients with solid tumors and uncontrolled metastases to the brain established in Phase 2a will be evaluated. Phase 2b will be initiated for patients with Astrocytoma IDH-mutant or Glioblastoma IDH-wildtype alongside Phase 2a. There will be up to 28 patients enrolled to have 27 evaluable patients enrolled in each Phase 2b Treatment Group.

For all phases of the study, NEO212 will be self-administered daily for days 1-5 of a 28- day treatment cycle.

02

Conditions studied

  • 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

Keywords

  • Astrocytoma
  • IDH-mutant
  • Glioblastoma
  • IDH-wildtype
  • Brain Metastases
  • CNS Tumor
  • GBM
  • NeOnc
  • Anova
  • NEO212
  • NEO100
  • TMZ
03

In context

Glioblastoma Reclassified

2,132 studies on the registry are indexed under Glioblastoma; 464 are open to participants now.

This study's planned enrollment of 134 is above the median of 36 across 1,753 interventional studies indexed under Glioblastoma.

Browse Glioblastoma studies →

Lead sponsor

Neonc Technologies, Inc. is the lead sponsor of 4 studies on the registry; 3 are open to participants now.

Compared within Glioblastoma, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Astrocytoma. The counts are of registry records indexed under each term, refreshed daily. How we classify →

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Inclusion Criteria:

  • Patient must be ≥ 18yrs of age.
  • Patient must have the ability to understand, and the willingness to sign, a written form.
  • Patient has been on a stable or decreasing dose of 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 /resection.
  • Patient with Astrocytoma IDH-mutant, Glioblastoma IDH-wildtype must have a Performance Status (KPS) of ≥ 60.
  • Patient with select solid tumors must have an (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:

    • ≥ 1,500/microliter
    • ≥ 100,000/microliter
    • Total within normal institutional limits
    • (SGOT) / ALT (SPGT) ≤ 2.5 x institutional
    • (CrCl) of >60 mL/min (using the Cockcroft-Gault formula or 24- hour urine collection).
  • Female patients of and male patients must agree to use adequate (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.

A female of child-bearing potential is any women (regardless of sexual orientation, not having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:

  • Has not undergone a hysterectomy or bilateral oophorectomy; or
  • Has not been naturally 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.

Phase 1: (dose escalation)

  • 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 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 (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).

NOTE: No washout is necessary for alternating electrical fields.

Phase 2a: (safety run-in)

  • 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 v1.1 criteria.

Phase 2b: (efficacy)

  • 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 Criteria: (all Phases)

  • 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 .
  • 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 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).
Terms in these criteria, in plain language(19)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Biopsy and archival tissue

A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.

Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.

Karnofsky performance status (KPS)

A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.

Studies often ask for 60 or 70 and above. Your doctor gives the score.

ECOG performance status

A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.

Absolute neutrophil count (ANC)

The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.

It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.

Platelets

Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.

Bilirubin

A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.

Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.

ALT and AST (liver enzymes)

Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.

Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.

ULN (upper limit of normal)

The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.

“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.

Creatinine clearance (CrCl)

How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Postmenopausal

Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

Washout period

A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.

RECIST

The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.

“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.

Leptomeningeal disease

Cancer that has spread to the leptomeninges, the thin layers covering the brain and spinal cord, and the fluid between them. It is not the same as brain metastases.

Criteria often treat it separately, and many studies leave it out even where treated brain metastases are allowed.

QT and QTc

On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.

The study may name a correction formula and a limit in milliseconds, often around 450–480.

05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
134 participants (estimated)

Study arms

  • Experimental
    Phase 2a Safety Run-In - NEO212 and Ipilimumab

    \- Unresectable or metastatic melanoma with uncontrolled metastases to the brain. NEO212 - Starting one dose level under RP2D administered orally on days 1 - 5 of a 28-day treatment cycle, escalated to RP2D per Protocol dose escalation rules. Ipilimumab - 3 mg/kg administered IV over 90 minutes every 3 weeks for a maximum of 3 doses per package insert.

    Drug: NEO212 Oral Capsule · Drug: Ipilimumab

  • Experimental
    Phase 2a Safety Run-In - NEO212 and Pembrolizumab

    The following primary cancers with uncontrolled metrastases to the brain: * Unresectable or metastatic melanoma. * NSCLC expressing PD-L1, with no EGFR or ALK genomic tumor aberrations. * Metastatic NSCLC whose tumors express PD-L1. * EGFR or ALK genomic tumor aberrations must have disease progression. * SCLC. * Unresectable, recurrent HNSCC whose tumors express PD-L1. * HNSCC on or after platinum-containing chemotherapy. * Urothelial carcinoma whose tumors express PD-L1. * Urothelial carcinoma. * Microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR). * Microsatellite Instability-high or Mismatch Repair Deficient Colorectal Cancer (CRC). * Gastric or gastroesophageal junction adenocarcinoma. * Esophageal or gastroesophageal juncUon (GEJ). * Cervical cancer. * Merkel cell carcinoma. NEO212 - Same as Arm 1. Pembrolizumab - 200 mg administered every 3 weeks per package insert.

    Drug: NEO212 Oral Capsule · Drug: Pembrolizumab

  • Experimental
    Phase 2a Safety Run-In - NEO212 and Nivolumab

    The following primary cancers with uncontrolled metrastases to the brain: * Unresectable or metastatic melanoma. * Metastatic non-small cell lung cancer. * Advanced renal cell carcinoma. * Squamous cell carcinoma of the head and neck. * Urothelial carcinoma. * Microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer. * Unresectable esophageal squamous cell carcinoma (ESCC). NEO212 - Starting one dose level under RP2D administered orally on days 1 - 5 of a 28-day treatment cycle, escalated to RP2D per Protocol dose escalation rules. Nivolumab - 240 mg administered every 2 weeks per package insert

    Drug: NEO212 Oral Capsule · Drug: Nivolumab

  • Experimental
    Phase 2a Safety Run-In - NEO212 and Stivarga (Regorafenib)

    \- Colorectal cancer (CRC) with uncontrolled metastases to the brain who have been previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an anti-VEGF therapy, and, if KRAS wild type, an anU-EGFR therapy. NEO212 - Starting one dose level under RP2D administered orally on days 1 - 5 of a 28-day treatment cycle, escalated to RP2D per Protocol dose escalation rules. Stivarga - 160 mg orally, once daily for the first 21 days of each 28-day cycle per package insert

    Drug: NEO212 Oral Capsule · Drug: Regorafenib

  • Experimental
    Phase 2a Safety Run-In - NEO212 and CarbolaUn (ParaplaUn) + Paclitaxel (Taxol)

    \- Colorectal cancer (CRC) with uncontrolled metastases to the brain. NEO212 - Starting one dose level under RP2D administered orally on days 1 - 5 of a 28-day treatment cycle, escalated to RP2D per Protocol dose escalation rules. Carboplatin - 300 mg/m2 IV on day 1 every 4 weeks for 6 cycles per package insert. Paclitaxel - 135mg/m2 IV administered over 24 hours, every 3 weeks per package insert.

    Drug: NEO212 Oral Capsule · Drug: Carboplatin · Drug: Paclitaxel

  • Experimental
    Phase 2a Safety Run-In - NEO212 and FOLFIRI (Zaltrap) + Bevacizumab (Avastin)

    \- Metastatic colorectal cancer (mCRC) with uncontrolled metastases to the brain, that is resistant to or has progressed following an oxaliplatin-containing regimen NEO212 - Starting one dose level under RP2D administered orally on days 1 - 5 of a 28-day treatment cycle, escalated to RP2D per Protocol dose escalation rules. FOLFIRI - 4 mg/kg aIV over 1 hour every 2 weeks. Bevacizumab - 10 mg/kg IV every 2 weeks.

    Drug: NEO212 Oral Capsule · Drug: FOLFIRI Protocol · Drug: Bevacizumab

  • Experimental
    Phase 2b efficacy - NEO212 for Astrocytoma IDH-mutant and Glioblastoma IDH-wildtype

    Patients receiving NEO212 alone for treatment of Astrocytoma IDH-mutant and Glioblastoma IDH-wildtype. NEO212 - Starting one dose level under RP2D administered orally on days 1 - 5 of a 28-day treatment cycle, escalated to RP2D per Protocol dose escalation rules.

    Drug: NEO212 Oral Capsule

  • Experimental
    Phase 2b efficacy - NEO212 & SOC for Uncontrolled Metastases to the Brain

    Patients receiving NEO212 in combination with select standard of care treatments for treatment of uncontrolled metastases to the brain. NEO212 - Starting one dose level under RP2D administered orally on days 1 - 5 of a 28-day treatment cycle, escalated to RP2D per Protocol dose escalation rules. SOC treatments established to be safe in Phase 2a of the study will be used in this arm of Phase 2b.

    Drug: NEO212 Oral Capsule · Drug: Ipilimumab · Drug: Pembrolizumab · Drug: Nivolumab · Drug: Regorafenib · Drug: Carboplatin · Drug: Paclitaxel · Drug: FOLFIRI Protocol · Drug: Bevacizumab

Interventions

  • DrugNEO212 Oral Capsule

    NEO212 is a novel chemical entity that was generated by covalent conjugation of temozolomide (TMZ) with perillyl alcohol (POH).

    Also known as: POH-TMZ

  • Ipilimumab, sold under the brand name Yervoy, is a monoclonal antibody medication that works to activate the immune system by targeting CTLA-4, a protein receptor that downregulates the immune system. Cytotoxic T lymphocytes can recognize and destroy cancer cells.

    Also known as: Yervoy

  • Pembrolizumab, sold under the brand name Keytruda, is a humanized antibody used in cancer immunotherapy that treats melanoma, lung cancer, head and neck cancer, Hodgkin lymphoma, stomach cancer, cervical cancer, and certain types of breast cancer. It is given by slow injection into a vein.

    Also known as: Keytruda

  • Nivolumab, sold under the brand name Opdivo, is a medication used to treat a number of types of cancer.

    Also known as: Opdivo

  • Regorafenib, sold under the brand name Stivarga among others, is an oral multi-kinase inhibitor developed by Bayer which targets angiogenic, stromal and oncogenic receptor tyrosine kinase. Regorafenib shows anti-angiogenic activity due to its dual targeted VEGFR2-TIE2 tyrosine kinase inhibition

    Also known as: Stivagra

  • Carboplatin, sold under the trade name Paraplatin among others, is a chemotherapy medication used to treat a number of forms of cancer. This includes ovarian cancer, lung cancer, head and neck cancer, brain cancer, and neuroblastoma. It is used by injection into a vein.

    Also known as: Paraplatin

  • Paclitaxel, sold under the brand name Taxol among others, is a chemotherapy medication used to treat ovarian cancer, esophageal cancer, breast cancer, lung cancer, Kaposi's sarcoma, cervical cancer, and pancreatic cancer. It is administered by intravenous injection

    Also known as: Taxol

  • FOLFIRI is a chemotherapy regimen for treatment of colorectal cancer. It is made up of the following drugs: FOL - folinic acid (leucovorin), a vitamin B derivative with multiple applications, which in this context increases the cytotoxicity of 5-fluorouracil; F - fluorouracil (5-FU), a pyrimidine analog and antimetabolite which incorporates into the DNA molecule and stops synthesis; and IRI - irinotecan (Camptosar), a topoisomerase inhibitor, which prevents DNA from uncoiling and duplicating.

    Also known as: Zaltrap

  • Bevacizumab, sold under the brand name Avastin among others, is a medication used to treat a number of types of cancers and a specific eye disease. For cancer, it is given by slow injection into a vein and used for colon cancer, lung cancer, glioblastoma, and renal-cell carcinoma

    Also known as: Avastin, Mvasi, Zirabev, Alymsys, Vegzelma

06

What researchers measure

Primary outcomes

  1. 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

    As determined by incidence and severity of adverse events according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE v5.0

    Time frame: 6 months

  2. Phase 1: Identify the maximum tolerated dose (MTD) of NEO212

    Maximum Tolerated Dose of NEO212 as determined by the dose escalation rules.

    Time frame: 6 months

  3. Phase 1: Determine the recommended Phase 2 dose (RP2D) of NEO212

    Determine the recommended Phase 2 dose (RP2D) of NEO212

    Time frame: 6 months

  4. 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

    Determined by incidence and severity of adverse events determined according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE v5.0).

    Time frame: 6 months

  5. 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.

    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.

    Time frame: 6 months

  6. 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.

    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.

    Time frame: 6 months

07

Study locations

8 of 8 sites recruiting
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Nov 2023 (actual). Primary completion is estimated for Feb 2027, 39 months after the start.

Of 53 industry-sponsored phase 1/2 interventional studies under Glioblastoma, half reached primary completion within 55 months of starting (the median), counting those still running; a quarter within 39 and three quarters within 75. This study's planned 39 months is below that.

Counting every sponsor, half of 137 studies reached it within 66 months; a quarter within 45 and three quarters within 100.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 17, 2023
First posted
Sep 21, 2023
StartActual
Nov 1, 2023
Primary completionEst.
Feb 28, 2027
CompletionEst.
Aug 31, 2027
Last update
Sep 24, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 24, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06047379
Lead sponsor
Neonc Technologies, Inc.
Responsible party
Sponsor
First posted
Sep 21, 2023
Start date
Nov 1, 2023
Primary completion
Feb 28, 2027 (estimated)
Completion
Aug 31, 2027 (estimated)
Last update
Sep 24, 2026

Study contacts

Christopher Beardmore
Contact
chris@anovaevidence.com
224 218 2408
Chloe Richmond
Contact
chloe@anovaevidence.com
224 218 2408
Tom Chen, MD, PhD
study chair · NeOnc Technologies
Josh Neman, PhD
study director · NeOnc Technologies Holdings, Inc.

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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