Phase I Study of APX005M in Pediatric Central Nervous System Tumors
1期
进行中(已停止招募)
NCT03389802
| 适应症 | Glioblastoma Multiforme, High-grade Astrocytoma Not Otherwise Specified, CNS Primary Tumor, Not Otherwise Specified, Ependymoma, Not Otherwise Specified |
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| 分期 | 1期 |
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| 申办方 | Pediatric Brain Tumor Consortium |
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| 状态 | 进行中(已停止招募) |
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| 受试者人数 | 32 人 |
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| 干预(药物) | APX005M treatment for recurrent or refractory primary malignant CNS tumor patients, APX005M treatment for newly diagnosed DIPG patients |
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| 开始日期 | 2018年3月1日 |
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| 完成日期 | 2023年9月30日 |
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| 结果公布日 | 2024年10月10日 |
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摘要
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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本页整理自 ClinicalTrials.gov 的公开数据,不构成医疗建议,也不构成投资建议。请务必咨询专业医师。