BENITIONSClinical Trial Intelligence

Phase I Study of APX005M in Pediatric Central Nervous System Tumors

第1相 実施中(募集終了) NCT03389802

対象疾患Glioblastoma Multiforme, High-grade Astrocytoma Not Otherwise Specified, CNS Primary Tumor, Not Otherwise Specified, Ependymoma, Not Otherwise Specified
第1相
スポンサーPediatric Brain Tumor Consortium
ステータス実施中(募集終了)
参加者数32 名
介入(薬剤)APX005M treatment for recurrent or refractory primary malignant CNS tumor patients, APX005M treatment for newly diagnosed DIPG patients
開始日2018年3月1日
完了日2023年9月30日
結果公開日2024年10月10日

概要

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

BENITIONS で見る ClinicalTrials.gov の原文を見る

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