Phase I Study of APX005M in Pediatric Central Nervous System Tumors

Phase 1 Active, not recruiting NCT03389802

Summary

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

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

Open in BENITIONS View on ClinicalTrials.gov

Other trials for this condition

• Solriamfetol in Improving Sleep in Patients With Grade II-IV Glioma — Wake Forest University Health Sciences
• Temozolomide With or Without Veliparib in Treating Patients With Newly Diagnosed Glioblast — National Cancer Institute (NCI)
• TORC1/2 Inhibitor MLN0128 and Bevacizumab in Treating Patients With Recurrent Glioblastoma — National Cancer Institute (NCI)
• Genetically Modified T-cells in Treating Patients With Recurrent or Refractory Malignant G — City of Hope Medical Center
• Phase II Study of BKM120 for Subjects With Recurrent Glioblastoma — L. Nicolas Gonzalez Castro, MD, PhD
• A Safety Study of Pharmacologic Ascorbate and Ferumoxytol in Addition to Standard of Care — Bryan Allen

All trials