BENITIONSClinical Trial Intelligence

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
分期1期
申办方Pediatric Brain Tumor Consortium
状态进行中(已停止招募)
受试者人数32 人
干预(药物)APX005M treatment for recurrent or refractory primary malignant CNS tumor patients, APX005M treatment for newly diagnosed DIPG patients
开始日期2018年3月1日
完成日期2023年9月30日
结果公布日2024年10月10日

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 10 Participants
Stratum 1, Dose Level 20 Participants
Stratum 1, Dose Level 32 Participants
Stratum 2, Dose Level 20 Participants
Stratum 2, Dose Level 33 Participants

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

Stratum 10.6 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

Stratum 20.3 mg/kg

在 BENITIONS 中查看 查看 ClinicalTrials.gov 原文

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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。