Phase I Study of APX005M in Pediatric Central Nervous System Tumors
Фаза 1
Идёт, набор закрыт
NCT03389802
| Заболевание | Glioblastoma Multiforme, High-grade Astrocytoma Not Otherwise Specified, CNS Primary Tumor, Not Otherwise Specified, Ependymoma, Not Otherwise Specified |
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| Фаза | Фаза 1 |
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| Спонсор | Pediatric Brain Tumor Consortium |
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| Статус | Идёт, набор закрыт |
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| Участники | 32 участн. |
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| Вмешательство | APX005M treatment for recurrent or refractory primary malignant CNS tumor patients, APX005M treatment for newly diagnosed DIPG patients |
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| Дата начала | 1.03.2018 |
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| Дата завершения | 30.09.2023 |
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| Публикация результатов | 10.10.2024 |
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Кратко
This phase I trial studies the side effects and best dose of APX005M in treating younger patients with primary malignant central nervous system tumor that is growing, spreading, or getting worse (progressive), or newly diagnosed diffuse intrinsic pontine glioma. APX005M can trigger activation of B cells, monocytes, and dendritic cells and stimulate cytokine release from lymphocytes and monocytes. APX005M can mediate a direct cytotoxic effect on CD40+ tumor cells.
Number of Patients Who Experienced Dose-limiting Toxicities (DLTs)
6 weeks · Participants
| Stratum 1, Dose Level 1 | 0 Participants |
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| Stratum 1, Dose Level 2 | 0 Participants |
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| Stratum 1, Dose Level 3 | 2 Participants |
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| Stratum 2, Dose Level 2 | 0 Participants |
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| Stratum 2, Dose Level 3 | 3 Participants |
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Maximum Tolerated Dose (MTD) and/or Recommended Phase II Dose (RP2D) of APX005M in Stratum 1
6 weeks (first 2 courses of treatment) · mg/kg
Maximum Tolerated Dose (MTD) and/or Recommended Phase II Dose (RP2D) of APX005M in Stratum 2
6 weeks (first 2 courses of treatment) · mg/kg
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