drugset / Trial / NCT04771897
A Study of BXQ-350 in Children With Newly Diagnosed Diffuse Intrinsic Pontine Glioma (DIPG) or Diffuse Midline Glioma (DMG)
Phase 1
Terminated
10 enrolled
Bexion Pharmaceuticals, Inc.
CTI Clinical Trial and Consulting Services · collab
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | SAPOSIN C (NON-GLYCOSYLATED) | Other / unclassified | — | Intravenous |