A Phase I/IIa Randomized Clinical trial to Evaluate the Efficacy of EGFR-targeted, PNU159682-packaged Nanocells and Glycolipid-Packaged Nanocells in combination withGemcitabine and Nab-paclitaxel in Metastatic Pancreatic Ductal Adenocarcinoma

The purpose of this study is to test a new experimental treatment for people with pancreatic cancer that has spread (metastatic PDAC). The experimental treatment being evaluated is called EGFR-targeted EnGeneIC Dream Vector™ (EDV™), carrying a drug called PNU-159682, or E-EDV-D682, referred to as the “study drug.” The study drug is investigational and has not been approved by the United States Food and Drug Administration (FDA). The study drug is a type of chemotherapy packaged inside a delivery vehicle (manufactured from a non–disease- causing salmonella bacteria) called an “EDV,” which transports the drug directly to the tumor through the bloodstream. A second investigational drug, “EDV-GC,” which contains α-galactosyl ceramide (an interferon thought to boost the body’s immune system), will also be given. The combination of these two investigational drugs is known as E-EDV-D682/GC. In this research study, the study drug plus adjuvant therapy is being tested in combination with the standard chemotherapy for PDAC (gemcitabine and nab-paclitaxel). Subjects in this study will be assigned to receive either the study drug combination or a placebo, depending on the group they are placed in.

Are you Eligible? (Inclusion Criteria)

• Male or female 18 years of age or older - Able to sign consent form - Confirmed pancreatic disease has spread to other parts of the body by examining tissue or cell sample under a microscope