drugset / Trial / NCT04771897

A Study of BXQ-350 in Children With Newly Diagnosed Diffuse Intrinsic Pontine Glioma (DIPG) or Diffuse Midline Glioma (DMG)

NCT04771897 ↗

Non-randomizedSequentialOpen-labelTreatment

Summary

This study will evaluate the safety of BXQ-350 and determine the maximum tolerated dose (MTD) in children with newly diagnosed DIPG or DMG. All patients will receive BXQ-350 by intravenous (IV) infusion and radiation therapy. The study is divided into two parts: Part 1 will enroll patients at increasing dose levels of BXQ-350 in order to determine the MTD. Part 2 will enroll patients requiring a biopsy in order to assess BXQ-350 concentrations in the biopsied tumor.

Timeline

Start
2021-05-24
Primary completion
2024-10-04
Completion
2024-10-04

Outcome

Outcome not reported

Stopped (Enrollment): “Bexion Pharmaceuticals has decided to close the BXQ-350.AD study to enrollment prior to the anticipated enrollment goal. Justification for this decision is due to slow enrollment and the competitive landscape of the indication.”

Drugs

EvaluationDrugModalityDoseRoute
Subject SAPOSIN C (NON-GLYCOSYLATED) Other / unclassified — Intravenous