drugset / Trial / NCT03967093

A Study of BXQ-350 in Children and Young Adults With Relapsed Solid Tumors

NCT03967093 ↗

Non-randomizedSequentialOpen-labelTreatment

Summary

This study will evaluate the safety of BXQ-350 and determine the maximum tolerated dose (MTD) in children and young adults with relapsed solid tumors, including recurrent malignant brain tumors. All patients will receive BXQ-350 by intravenous (IV) infusion. 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 use the MTD to further assess the safety of BXQ-350 as well as preliminary anti-tumor activity.

Timeline

Start
2019-04-15
Primary completion
2020-01-03
Completion
2020-01-17

Outcome

Outcome not reported

Stopped: “Bexion will not move forward with the Part 2 expansion portion of the trial in order to focus resources on the further development of BXQ-350 as an earlier treatment measure in the pediatric population.”

Drugs

EvaluationDrugModalityDoseRoute
Subject SAPOSIN C (NON-GLYCOSYLATED) Other / unclassified 3.2 mg/kg Intravenous

Indications