Study of Nab-Paclitaxel and Gemcitabine and Plus/Minus VCN-01 in Patients With Metastatic Pancreatic Cancer

Multi‐center, open label, randomized, 2‐parallel arm, phase IIb study of nab‐paclitaxeland gemcitabine as Standard of Care (SoC) plus/minus VCN‐01 in patients with metastaticpancreatic cancer. Gemcitabine and nab‐paclitaxel are chemotherapy drugs approved by theFDA to treat pancreatic cancer. VCN‐01 is a genetically modified adenovirus characterizedby the presence of four independent genetic modifications in the backbone of thewild‐type human adenovirus serotype 5 (HAd5) genome that confer tumor selectivereplication and antitumor activity. Approximately 92 patients in sites in North Americaand European Union (EU) will be recruited and randomized in a 1:1 ratio to one of twotreatment arms (i.e., approximately 46 patients per treatment arm): ‐ Arm 1‐ (SoC): Nab‐paclitaxel and gemcitabine as SoC (28‐day cycles). Patients inthis arm will not receive the investigational medicinal product (IMP) VCN‐01. ‐ Arm 2‐ (VCN‐01+ SoC): A maximum of two (2) doses of VCN‐01 administrated incombination with nab‐paclitaxel and gemcitabine as SoC (28‐day cycles with exceptionof the IMP dose cycles, which will be 35‐day cycles).A Data Monitoring Committee (DMC) will be convened at regular intervals to assess safetyand to look at OS to determine if the trial can continue.