drugset / Trial / NCT00625456

Safety Study of Recombinant Vaccinia Virus to Treat Refractory Solid Tumors

NCT00625456

Phase 1 Completed 23 enrolled Jennerex Biotherapeutics
Non-randomizedSingle-groupOpen-labelTreatment

Summary

This is a Phase I, open-label, dose-escalation trial in patients with advanced/metastatic solid tumors refractory to standard therapy; tumors may include malignant melanoma, non-small cell lung cancer, renal cell carcinoma, and squamous cell carcinoma of the head and neck. These tumor types were selected because evidence of biological activity was observed in these tumor types in a Phase I study of JX-594 (Pexa-Vec) administered by intratumoral injection in patients with metastatic disease to the liver. Patients will receive treatment at one of five dose levels in a sequential dose-escalating design.

Timeline

Start
2008-06
Primary completion
2010-04
Completion
2014-06

Drugs

EvaluationDrugModalityDoseRoute
Subject Pexastimogene Devacirepvec Other / unclassified Intravenous