NCT00794131

Safety Study of GL-ONC1, an Oncolytic Virus, in Patients With Advanced Solid Tumors

Phase I Study of the Safety, Tolerability,and Tumor-Specific Replication of the Intravenous Administration of Green Fluorescent Protein Encoded Genetically Engineered Attenuated Vaccinia Virus, GL-ONC1, in Patients With Advanced Solid Organ Cancers.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 43 (actual)
• Sponsor: Genelux GmbH · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The main purpose of this study is to determine whether, GL-ONC1, an Oncolytic Virus, can safely be administered intravenously in patients with advanced solid tumors.

Detailed description

In preclinical studies, GL-ONC1 an oncolytic vaccinia virus, has shown the ability to preferentially locate, colonize and destroy tumor cells. This study seeks to evaluate the safety profile of an attenuated vaccinia virus when administered intravenously to patients with advanced solid tumors. The study also seeks to detect virus delivery to primary and/or metastatic tumors, including evaluation of viral delivery by fluorescence imaging (GFP expression); whether anti-vaccinia virus immune response occurs; and will record evidence of any anti-tumor activity. For Cohorts 8 and Expansion Cohort 1B, CTC counts, virus-encoded marker gene analysis and Dynamic Contrast (DCE-MRI) MRI imaging will be used to evaluate tumor micro-circulation in vivo. These measures will be evaluated for their potential predictive value of survival outcomes, and to evaluate any correlation of such pharmacodynamic and response rate indicators in the GL-ONC1 treatment context.

Conditions

• Advanced Cancers (Solid Tumors)

Interventions

Type	Name	Description
BIOLOGICAL	GL-ONC1	a genetically-engineered vaccinia virus (encoding Renilla luciferase-Aequorea green fluorescent protein fusion, β-galactosidase, and β-glucuronidase )

Timeline

• Start date: 2008-11-01
• Primary completion: 2015-11-01
• Completion: 2015-11-01
• First posted: 2008-11-19
• Last updated: 2025-04-24

Locations

1 site across 1 country: United Kingdom