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Segurança e eficácia do NEO212 em pacientes com astrocitoma IDH mutante, glioblastoma IDH tipo selvagem ou metástase cerebral

21 de setembro de 2026 atualizado por: Neonc Technologies, Inc.

Um estudo aberto de descoberta de dose, segurança e eficácia de fase 1/2 de NEO212 oral em pacientes com astrocitoma IDH mutante, glioblastoma IDH de tipo selvagem ou metástase cerebral não controlada em pacientes com tumores sólidos selecionados.

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.

Visão geral do estudo

Status

Recrutamento

Condições

Intervenção / Tratamento

Descrição detalhada

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.

Tipo de estudo

Intervencional

Inscrição (Estimado)

134

Estágio

  • Fase 2
  • Fase 1

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

Estude backup de contato

Locais de estudo

  • Estados Unidos
    • California
      • Beverly Hills, California, Estados Unidos, 90212
        • Recrutamento
        • Precision NextGen Oncology
        • Investigador principal:
          • Kamlesh Sankhala, MD
        • Contato:
      • Glendale, California, Estados Unidos, 91203
        • Recrutamento
        • OPN Healthcare, Inc
        • Investigador principal:
          • Vu Phan, MD
        • Contato:
      • Los Angeles, California, Estados Unidos, 90033
        • Recrutamento
        • University of Southern California
        • Investigador principal:
          • Frances Chow, MD
        • Contato:
    • Florida
      • Boynton Beach, Florida, Estados Unidos, 33426
        • Recrutamento
        • MDR Core Network
        • Investigador principal:
          • Robert Levin, MD
        • Contato:
    • Massachusetts
      • Boston, Massachusetts, Estados Unidos, 21111
    • Tennessee
      • Nashville, Tennessee, Estados Unidos, 37232
        • Recrutamento
        • Vanderbilt University Medical Center
        • Investigador principal:
          • Alexander Mohler, MD
        • Contato:
    • Texas
      • Dallas, Texas, Estados Unidos, 75246
        • Recrutamento
        • Baylor, Scott and White Research Institute
        • Contato:
        • Investigador principal:
          • Divya Mella, MD
    • Washington
      • Tacoma, Washington, Estados Unidos, 98405
        • Recrutamento
        • Northwest Medical Specialties
        • Investigador principal:
          • Jorge Chaves, MD
        • Contato:

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

18 anos e mais velhos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Descrição

Inclusion Criteria:

  • 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.

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.

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 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).

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: Não randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
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.
Medicamento: NEO212 Oral Capsule

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

Outros nomes:
  • POH-TMZ
Medicamento: Ipilimumab

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.

Outros nomes:
  • Yervoy
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.
Medicamento: NEO212 Oral Capsule

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

Outros nomes:
  • POH-TMZ
Medicamento: Pembrolizumab

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.

Outros nomes:
  • Keytruda
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
Medicamento: NEO212 Oral Capsule

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

Outros nomes:
  • POH-TMZ
Medicamento: Nivolumab

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

Outros nomes:
  • Opdivo
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
Medicamento: NEO212 Oral Capsule

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

Outros nomes:
  • POH-TMZ
Medicamento: Regorafenib

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

Outros nomes:
  • Stivagra
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.
Medicamento: NEO212 Oral Capsule

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

Outros nomes:
  • POH-TMZ
Medicamento: Carboplatin

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.

Outros nomes:
  • Paraplatina
Medicamento: Paclitaxel

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

Outros nomes:
  • Taxol
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.
Medicamento: NEO212 Oral Capsule

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

Outros nomes:
  • POH-TMZ
Medicamento: FOLFIRI Protocol

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.

Outros nomes:
  • Zaltrap
Medicamento: Bevacizumab

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

Outros nomes:
  • AvastinName
  • Mvasi
  • Zirabev
  • Vegzelma
  • Alymsys
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.
Medicamento: NEO212 Oral Capsule

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

Outros nomes:
  • POH-TMZ
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.
Medicamento: NEO212 Oral Capsule

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

Outros nomes:
  • POH-TMZ
Medicamento: Ipilimumab

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.

Outros nomes:
  • Yervoy
Medicamento: Pembrolizumab

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.

Outros nomes:
  • Keytruda
Medicamento: Nivolumab

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

Outros nomes:
  • Opdivo
Medicamento: Regorafenib

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

Outros nomes:
  • Stivagra
Medicamento: Carboplatin

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.

Outros nomes:
  • Paraplatina
Medicamento: Paclitaxel

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

Outros nomes:
  • Taxol
Medicamento: FOLFIRI Protocol

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.

Outros nomes:
  • Zaltrap
Medicamento: Bevacizumab

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

Outros nomes:
  • AvastinName
  • Mvasi
  • Zirabev
  • Vegzelma
  • Alymsys

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
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
Prazo: 6 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
6 months
Phase 1: Identify the maximum tolerated dose (MTD) of NEO212
Prazo: 6 months

Maximum Tolerated Dose of NEO212 as determined by the dose escalation rules.
6 months
Phase 1: Determine the recommended Phase 2 dose (RP2D) of NEO212
Prazo: 6 months

Determine the recommended Phase 2 dose (RP2D) of NEO212
6 months
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
Prazo: 6 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).
6 months
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.
Prazo: 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.
6 months
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.
Prazo: 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.
6 months

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Neonc Technologies, Inc.

Investigadores

  • Cadeira de estudo: Tom Chen, MD, PhD, NeOnc Technologies
  • Diretor de estudo: Josh Neman, PhD, NeOnc Technologies Holdings, Inc.

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

1 de novembro de 2023

Conclusão Primária (Estimado)

28 de fevereiro de 2027

Conclusão do estudo (Estimado)

31 de agosto de 2027

Datas de inscrição no estudo

Enviado pela primeira vez

17 de agosto de 2023

Enviado pela primeira vez que atendeu aos critérios de CQ

18 de setembro de 2023

Primeira postagem (Real)

21 de setembro de 2023

Atualizações de registro de estudo

Última Atualização Postada (Real)

24 de setembro de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

21 de setembro de 2026

Última verificação

1 de setembro de 2026

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • NEO212-01

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Sim

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

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