BENITIONSClinical Trial Intelligence

Phase I Study of APX005M in Pediatric Central Nervous System Tumors

1상 진행 중(모집 완료) NCT03389802

대상 질환Glioblastoma Multiforme, High-grade Astrocytoma Not Otherwise Specified, CNS Primary Tumor, Not Otherwise Specified, Ependymoma, Not Otherwise Specified
임상 단계1상
스폰서Pediatric Brain Tumor Consortium
상태진행 중(모집 완료)
참여자 수32 명
중재(약물)APX005M treatment for recurrent or refractory primary malignant CNS tumor patients, APX005M treatment for newly diagnosed DIPG patients
시작일2018년 3월 1일
완료일2023년 9월 30일
결과 공개일2024년 10월 10일

요약

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

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