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NCT04771897 · ClinicalTrials.gov registry record · Phase 1
A Study of BXQ-350 in Children With Newly Diagnosed Diffuse Intrinsic Pontine Glioma (DIPG) or Diffuse Midline Glioma (DMG)
A Phase 1 study, sponsored by Bexion Pharmaceuticals.
- Terminated
- Registry status
- Phase 1
- Development phase
- 10
- Enrollment target
NCT04771897: Clinical Trial Phase 1 study, sponsored by Bexion Pharmaceuticals.
NCT04771897 is a Phase 1 study that was terminated before completion, run by Bexion Pharmaceuticals. The registered enrollment target is 10 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (83% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04771897, a Phase 1 study, was terminated before completion, sponsored by Bexion Pharmaceuticals.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 10 participants
- Enrollment target
Study 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.
Primary Outcome
To determine the safety of BXQ-350 in children with newly diagnosed DIPG or DMG, as evidenced by the incidence of treatment emergent adverse events assessed by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Interventions
- DRUG BXQ-350 - Part 1 Dose Escalation: Safety and Tolerance
- DRUG BXQ-350 - Part 2 BXQ-350 Tumor and Plasma Concentrations
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2021-05-24 |
| Est. Completion | 2024-10-04 |
| Phase | Phase 1 |
Why NCT04771897 stopped before completion
NCT04771897 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (83% lower).
The record links to 0 conditions, and to 2 interventions - of which BXQ-350 - Part 1 Dose Escalation: Safety and Tolerance is the first listed.
NCT04771897 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04771897 about?
NCT04771897 is a clinical study titled "A Study of BXQ-350 in Children With Newly Diagnosed Diffuse Intrinsic Pontine Glioma (DIPG) or Diffuse Midline Glioma (DMG)". 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 increa...
What is the current status of trial NCT04771897?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 10 participants. The study started on 2021-05-24. Estimated completion is 2024-10-04.
What interventions are being tested in trial NCT04771897?
The interventions under investigation include: BXQ-350 - Part 1 Dose Escalation: Safety and Tolerance (DRUG), BXQ-350 - Part 2 BXQ-350 Tumor and Plasma Concentrations (DRUG).
Who is sponsoring clinical trial NCT04771897?
This trial is sponsored by Bexion Pharmaceuticals, which has 6 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04771897's enrollment target sits among peer trials
10 1913th of 2000 higher than 46 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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