drugset / Trial / NCT06126744

Open-Label Study to Evaluate the Safety, Tolerability and Efficacy of the Oncolytic HSV1 MVR-C5252

NCT06126744 ↗

Phase 1 Recruiting 51 enrolled Duke University
NaSequentialOpen-labelTreatment

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.

Timeline

Start
2024-06-11
Primary completion
2027-12-01
Completion
2028-12-01

Drugs

EvaluationDrugModalityDoseRoute
Subject MVR-C5252 Unknown — Other

Indications