drugset / Trial / NCT03967093
A Study of BXQ-350 in Children and Young Adults With Relapsed Solid Tumors
Phase 1
Terminated
9 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 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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | SAPOSIN C (NON-GLYCOSYLATED) | Other / unclassified | 3.2 mg/kg | Intravenous |