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Diffuse Astrocytoma, IDH-MutantPhase 1/2NCT06047379

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

A Phase 1/2 study testing NEO212 Oral Capsule, Ipilimumab and Pembrolizumab in people with Diffuse Astrocytoma, IDH-Mutant and Glioblastoma, IDH-wildtype, run by Neonc Technologies, Inc. at 8 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
NEO212 Oral Capsule, Ipilimumab and Pembrolizumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
134 participants
Where
8 sitesUnited States
Study dates
1 Nov 2023to 31 Aug 2027
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
Show all 47Show fewer
  • 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.
  • 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 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.
  • 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 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).
  • 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 RECIST 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.

Who cannot join

  • 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.
Show all 13Show fewer
  • 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).

Trial locations and contacts

8 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Christopher Beardmore contact

224 218 2408

chris@anovaevidence.com

Chloe Richmond contact

224 218 2408

chloe@anovaevidence.com

8 sites in 1 country

United States8 sites, 8 recruiting

  • Precision NextGen Oncology

    Beverly Hills, California, 90212

    Jing Liu, MD MA, (424) 777-0708, JingL@nextgenonc.com

    Kamlesh Sankhala, MD

    Recruiting

  • Tufts Medical Center

    Boston, Massachusetts, 21111

    Christian Lawlor, Christian.Lawlor@tuftsmedicine.org

    Soma Sengupta, MD

    Recruiting

  • MDR Core Network

    Boynton Beach, Florida, 33426

    Ismaray Hernandez, ismaray@mdrcore.com

    Robert Levin, MD

    Recruiting

  • Baylor, Scott and White Research Institute

    Dallas, Texas, 75246

    Tarah Satterfield, Tarah.Satterfield@bswhealth.org

    Divya Mella, MD

    Recruiting

  • OPN Healthcare, Inc

    Glendale, California, 91203

    Heather Lyon, heatherl@opnhc.com

    Vu Phan, MD

    Recruiting

  • University of Southern California

    Los Angeles, California, 90033

    Sandy Tran, (323) 865-3980, Sandy.Tran@med.usc.edu

    Frances Chow, MD

    Recruiting

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232

    Amanda Nolen, amanda.nolen@vumc.org

    Alexander Mohler, MD

    Recruiting

  • Northwest Medical Specialties

    Tacoma, Washington, 98405

    Sheila Marsh, 253-380-8173, smarsh@nwmsonline.com

    Jorge Chaves, MD

    Recruiting

Other trials in United States

About this study

Official title: An Open-label Phase 1/2 Dose Finding, Safety and Efficacy Study of Oral NEO212 in Patients With Astrocytoma IDH-mutant, Glioblastoma IDH-wildtype or Uncontrolled Brain Metastasis in Patients With Select Solid Tumors.

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.

Being tested
NEO212 Oral Capsule, Ipilimumab, Pembrolizumab, Nivolumab, Regorafenib
Keywords
Astrocytoma, IDH-mutant, Glioblastoma, IDH-wildtype, Brain Metastases, CNS Tumor, GBM, NeOnc, Anova, NEO212, NEO100, TMZ
Medical subject headings
Astrocytoma, Glioblastoma, Brain Neoplasms, Uterine Cervical Neoplasms, Colorectal Neoplasms, Esophageal Neoplasms, Esophageal Squamous Cell Carcinoma, Stomach Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NEO212 Oral CapsuleDrug

    Also called POH-TMZ

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

  • IpilimumabDrug

    Also called Yervoy

    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.

  • PembrolizumabDrug

    Also called Keytruda

    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.

  • NivolumabDrug

    Also called Opdivo

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

  • RegorafenibDrug

    Also called Stivagra

    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

  • CarboplatinDrug

    Also called Paraplatin

    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.

  • PaclitaxelDrug

    Also called Taxol

    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

  • FOLFIRI ProtocolDrug

    Also called Zaltrap

    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.

  • BevacizumabDrug

    Also called Avastin, Mvasi, Zirabev, Alymsys

    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

Study groups in NCT06047379
Study groupRoleWhat they receive
Phase 2a Safety Run-In - NEO212 and IpilimumabExperimental- 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.
Receives: Drug: NEO212 Oral Capsule; Drug: Ipilimumab
Phase 2a Safety Run-In - NEO212 and PembrolizumabExperimentalThe 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.
Receives: Drug: NEO212 Oral Capsule; Drug: Pembrolizumab
Phase 2a Safety Run-In - NEO212 and NivolumabExperimentalThe 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
Receives: Drug: NEO212 Oral Capsule; Drug: Nivolumab
Phase 2a Safety Run-In - NEO212 and Stivarga (Regorafenib)Experimental- 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
Receives: Drug: NEO212 Oral Capsule; Drug: Regorafenib
Phase 2a Safety Run-In - NEO212 and CarbolaUn (ParaplaUn) + Paclitaxel (Taxol)Experimental- 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.
Receives: Drug: NEO212 Oral Capsule; Drug: Carboplatin; Drug: Paclitaxel
Phase 2a Safety Run-In - NEO212 and FOLFIRI (Zaltrap) + Bevacizumab (Avastin)Experimental- 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.
Receives: Drug: NEO212 Oral Capsule; Drug: FOLFIRI Protocol; Drug: Bevacizumab
Phase 2b efficacy - NEO212 for Astrocytoma IDH-mutant and Glioblastoma IDH-wildtypeExperimentalPatients 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.
Receives: Drug: NEO212 Oral Capsule
Phase 2b efficacy - NEO212 & SOC for Uncontrolled Metastases to the BrainExperimentalPatients 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.
Receives: Drug: NEO212 Oral Capsule; Drug: Ipilimumab; Drug: Pembrolizumab; Drug: Nivolumab; Drug: Regorafenib; Drug: Carboplatin; Drug: Paclitaxel; Drug: FOLFIRI Protocol; Drug: Bevacizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 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.

    Measured: 6 months

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

    Determine the recommended Phase 2 dose (RP2D) of NEO212

    Measured: 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).

    Measured: 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.

    Measured: 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.

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Sep 2023
  2. Study start1 Nov 2023
  3. Primary completion28 Feb 2027 (estimated)
  4. Study completion31 Aug 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
134 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06047379
Sponsor's protocol ID
NEO212-01
Status last verified
Sep 2026
First submitted
17 Aug 2023
Last updated
24 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing NEO212 Oral Capsule, Ipilimumab and Pembrolizumab in people with Diffuse Astrocytoma, IDH-Mutant and Glioblastoma, IDH-wildtype, run by Neonc Technologies, Inc. at 8 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 47 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 24 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Christopher Beardmore (224 218 2408, chris@anovaevidence.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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 (time frame: 6 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06047379.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2026.

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