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Sicurezza ed efficacia di NEO212 in pazienti con astrocitoma IDH-mutante, glioblastoma IDH-wildtype o metastasi cerebrali

21 settembre 2026 aggiornato da: Neonc Technologies, Inc.

Uno studio di fase 1/2 in aperto per la ricerca della dose, la sicurezza e l'efficacia del NEO212 orale in pazienti con astrocitoma IDH-mutante, glioblastoma IDH-wildtype o metastasi cerebrali non controllate in pazienti con tumori solidi selezionati.

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.

Panoramica dello studio

Stato

Reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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 di studio

Interventistico

Iscrizione (Stimato)

134

Fase

  • Fase 2
  • Fase 1

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Backup dei contatti dello studio

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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).

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Non randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.
Droga: NEO212 Oral Capsule

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

Altri nomi:
  • POH-TMZ
Droga: 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.

Altri nomi:
  • Yevoy
Sperimentale: 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.
Droga: NEO212 Oral Capsule

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

Altri nomi:
  • POH-TMZ
Droga: 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.

Altri nomi:
  • Chiavetruda
Sperimentale: 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
Droga: NEO212 Oral Capsule

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

Altri nomi:
  • POH-TMZ
Droga: Nivolumab

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

Altri nomi:
  • Opdivo
Sperimentale: 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
Droga: NEO212 Oral Capsule

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

Altri nomi:
  • POH-TMZ
Droga: 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

Altri nomi:
  • Stivagra
Sperimentale: 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.
Droga: NEO212 Oral Capsule

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

Altri nomi:
  • POH-TMZ
Droga: 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.

Altri nomi:
  • Paraplatino
Droga: 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

Altri nomi:
  • Tassolo
Sperimentale: 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.
Droga: NEO212 Oral Capsule

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

Altri nomi:
  • POH-TMZ
Droga: 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.

Altri nomi:
  • Zaltrap
Droga: 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

Altri nomi:
  • Avastin
  • Mvasi
  • Zirabev
  • Vegzelma
  • Alymsys
Sperimentale: 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.
Droga: NEO212 Oral Capsule

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

Altri nomi:
  • POH-TMZ
Sperimentale: 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.
Droga: NEO212 Oral Capsule

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

Altri nomi:
  • POH-TMZ
Droga: 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.

Altri nomi:
  • Yevoy
Droga: 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.

Altri nomi:
  • Chiavetruda
Droga: Nivolumab

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

Altri nomi:
  • Opdivo
Droga: 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

Altri nomi:
  • Stivagra
Droga: 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.

Altri nomi:
  • Paraplatino
Droga: 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

Altri nomi:
  • Tassolo
Droga: 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.

Altri nomi:
  • Zaltrap
Droga: 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

Altri nomi:
  • Avastin
  • Mvasi
  • Zirabev
  • Vegzelma
  • Alymsys

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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.
Lasso di tempo: 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.
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Neonc Technologies, Inc.

Investigatori

  • Cattedra di studio: Tom Chen, MD, PhD, NeOnc Technologies
  • Direttore dello studio: Josh Neman, PhD, NeOnc Technologies Holdings, Inc.

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

1 novembre 2023

Completamento primario (Stimato)

28 febbraio 2027

Completamento dello studio (Stimato)

31 agosto 2027

Date di iscrizione allo studio

Primo inviato

17 agosto 2023

Primo inviato che soddisfa i criteri di controllo qualità

18 settembre 2023

Primo Inserito (Effettivo)

21 settembre 2023

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

24 settembre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

21 settembre 2026

Ultimo verificato

1 settembre 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • NEO212-01

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

Sì

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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