The purpose of this study is to test the effects, good and/or bad, of the investigational product, GL-ONC1, alone or in combination with eculizumab. This study aims to find the highest dose of GL-ONC1 that can be given alone, or with eculizumab, without causing unacceptable side effects. GL-ONC1 is considered experimental because it is not approved by the Food and Drug Administration (FDA) for the treatment of any disease. Eculizumab is approved by the FDA for the treatment of patients with paroxysmal nocturnal hemoglobinuria (PNH) or atypical hemolytic uremic syndrome (aHUS). Eculizumab is considered experimental in this study because it is not approved by the FDA for the treatment of cancer.
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 very successfully in the past as smallpox vaccine in many millions of people worldwide. Eculizumab is a type of drug called a monoclonal antibody. This drug is designed to inhibit the activity of a protein called complement. Complement is part of the body's immune system that destroys and removes foreign particles. Evidence from laboratory tests suggest eculizumab may allow GL-ONC1 to stay in the body longer before being cleared by the immune system, which may help destroy more cancer cells.