Solid Organ Cancers Clinical Trial
Official title:
An Open Label, Non-randomized Phase 1b Study to Investigate the Safety and Effect of the Oncolytic Virus GL-ONC1 Administered Intravenously Prior to Surgery to Patients With Solid Organ Cancers Undergoing Surgery for Curative-Intent or Palliative Resection
The purpose of this study is to evaluate the safety of the investigational product GL-ONC1. GL-ONC1, a vaccinia virus, has been genetically modified for use as a potential anti-cancer drug to destroy cancer cells. Vaccinia virus has been used successfully in the past as smallpox vaccine in millions of people worldwide.
This is an open-label, non-randomized Phase 1b dose escalation study evaluating the safety
and effect of the oncolytic virus GL-ONC1 administered intravenously, with or without
eculizumab, prior to surgery in patients with advanced solid organ tumors.
GL-ONC1 is a genetically engineered oncolytic vaccinia virus, which disrupts nonessential
genes and expression of the foreign gene expression. Evidence suggest that GL-ONC1 is able to
infect tumor tissue and kill tumor cells.
The goals of this study are to evaluate the safety of GL-ONC1 and to assess the
pharmacokinetics and pharmacodynamics profile of GL-ONC1 in vivo.
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