NCT03284268

Evaluate Safety and the Oncolitic Adenovirus VCN-01 Activity in Patients With Refractory Retinoblastoma

Phase I Study, Single Site, Open Label With Dose Escalation, for Evaluate Safety and the Oncolitic Adenovirus VCN-01 Activity in Patients With Refractory Retinoblastoma

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 13 (actual)
• Sponsor: Fundació Sant Joan de Déu · Academic / Other
• Sex: All
• Age: 1 Year – 12 Years
• Healthy volunteers: Not accepted

Summary

Phase I study, single site, open label with dose escalation, for evaluate safety and the oncolitic Adenovirus VCN-01 activity in patients with refractory retinoblastoma.

Detailed description

Phase I clinical trial, single-center, open-label, dose-escalation study, to evaluate the safety of the VCN-01 and, secondarily, its anti-tumoral activity. The trial sample consists of approximately 13 patients aged between 1 and 12 years old.

Conditions

• Retinoblastoma, Recurrent

Interventions

Type	Name	Description
GENETIC	VCN-01	VCN-01 intravitreal injection

Timeline

• Start date: 2017-09-06
• Primary completion: 2024-06-14
• Completion: 2024-06-14
• First posted: 2017-09-15
• Last updated: 2024-08-27

Locations

1 site across 1 country: Spain