NCT03714334

DNX-2440 Oncolytic Adenovirus for Recurrent Glioblastoma

Phase I Trial of DNX-2440 Oncolytic Adenovirus in Patients With Recurrent Glioblastoma

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Clinica Universidad de Navarra, Universidad de Navarra · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Patients with first or second recurrence of GBM will be treated with stereotactic injection of the oncolytic virus DNX-2440.

Detailed description

After inclusion in the trial, stereotactic biopsy will be performed. In the same surgery, the experimental agent will be injected also by stereotactic system, in a different part of the lesion, in a region considered viable tumor, using a cannula especially designed for virus injection. Follow-up will include clinical visits and MRI No other treatment for the tumor will be used until progression is documented. iRANO criteria and volumetric measurement of the tumor will be used. Any further treatment after progression will be at the criteria of the treating physician

Conditions

• Glioblastoma
• Glioblastoma, Adult

Interventions

Type	Name	Description
DRUG	DNX-2440 injection	DNX-2440 virus will be injected stereotactically

Timeline

• Start date: 2018-10-16
• Primary completion: 2023-04-05
• Completion: 2023-04-05
• First posted: 2018-10-22
• Last updated: 2023-04-07

Locations

1 site across 1 country: Spain