BENITIONSClinical Trial Intelligence

Phase I Study of APX005M in Pediatric Central Nervous System Tumors

Фаза 1 Идёт, набор закрыт NCT03389802

ЗаболеваниеGlioblastoma Multiforme, High-grade Astrocytoma Not Otherwise Specified, CNS Primary Tumor, Not Otherwise Specified, Ependymoma, Not Otherwise Specified
ФазаФаза 1
СпонсорPediatric Brain Tumor Consortium
СтатусИдёт, набор закрыт
Участники32 участн.
ВмешательствоAPX005M treatment for recurrent or refractory primary malignant CNS tumor patients, APX005M treatment for newly diagnosed DIPG patients
Дата начала1.03.2018
Дата завершения30.09.2023
Публикация результатов10.10.2024

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 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

Открыть в BENITIONS Открыть на ClinicalTrials.gov

Другие исследования по этому заболеванию

Все исследования

Страница обобщает открытые данные ClinicalTrials.gov. Это не медицинская и не инвестиционная рекомендация. Обратитесь к врачу.