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NCT06126744 · ClinicalTrials.gov registry record · Phase 1
Open-Label Study to Evaluate the Safety, Tolerability and Efficacy of the Oncolytic HSV1 MVR-C5252
A Phase 1 study of Recurrent High Grade Glioma, sponsored by Duke University.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 51
- Enrollment target
- 1
- Study location
NCT06126744: Recruiting Phase 1 study of Recurrent High Grade Glioma, sponsored by Duke University.
NCT06126744 is a Phase 1 study of Recurrent High Grade Glioma that is actively recruiting participants, run by Duke University. The registered enrollment target is 51 participants, above the 24-participant average among 4 other Recurrent High Grade Glioma trials with a reported enrollment target (113% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06126744, a Phase 1 study of Recurrent High Grade Glioma, is actively recruiting participants, sponsored by Duke University.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 51 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a Phase 1 open label study designed to assess the safety and tolerability of the oncolytic herpes simplex virus 1 (oHSV1) study drug, MVR-C5252, administered intratumorally by convection-enhanced delivery (CED) in patients with recurrent high-grade glioma. Once the safety and maximum tolerated dose (MTD) is established in the dose escalation portion of the trial, a dose expansion cohort at the recommended phase 2 dose (RP2D) in patients with isocitrate dehydrogenase (IDH) wildtype recurrent glioblastoma (GBM) will evaluate preliminary efficacy of the study drug.
Primary Outcome
Proportion of patients with dose-limiting toxicity (DLT) during the single infusion
Conditions Studied
Interventions
- BIOLOGICAL MVR-C5252
Study Locations (1)
North Carolina
- Duke University - Durham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 51 participants |
| Start Date | 2024-06-11 |
| Est. Completion | 2027-12-01 |
| Phase | Phase 1 |
What NCT06126744 shows while recruiting
NCT06126744 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 51 participants, a relatively small participant target, above the 24-participant average among 4 other Recurrent High Grade Glioma trials with a reported enrollment target (113% higher).
The record links to 1 condition, with Recurrent High Grade Glioma appearing as the primary indexed condition, and to 1 intervention - of which MVR-C5252 is the first listed.
NCT06126744 reports a single indexed study location in North Carolina.
Frequently Asked Questions
What is clinical trial NCT06126744 about?
NCT06126744 is a clinical study titled "Open-Label Study to Evaluate the Safety, Tolerability and Efficacy of the Oncolytic HSV1 MVR-C5252". This is a Phase 1 open label study designed to assess the safety and tolerability of the oncolytic herpes simplex virus 1 (oHSV1) study drug, MVR-C5252, administered intratumorally by convection-enhanced delivery (CED) in patients with recurrent high-grade glioma. Once the safety and maximum tolerat...
What is the current status of trial NCT06126744?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 51 participants. The study started on 2024-06-11. Estimated completion is 2027-12-01.
What conditions does trial NCT06126744 study?
This clinical trial studies the following conditions: Recurrent High Grade Glioma.
What interventions are being tested in trial NCT06126744?
The interventions under investigation include: MVR-C5252 (BIOLOGICAL).
Who is sponsoring clinical trial NCT06126744?
This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06126744 being conducted?
This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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