The study will start with a 150-subject sentinel cohort and may continue with an expansion cohort depending on the results of a futility analysis to be performed when 104 required PFS events (death or disease progression, whichever comes first) are observed in the sentinel cohort.
The study is a randomized, double-blind, placebo-controlled, multicenter study of standard treatment with nab-paclitaxel and gemcitabine with or without SBP-101 in subjects previously untreated for metastatic pancreatic ductal adenocarcinoma (PDA), including subjects who have received prior neoadjuvant or adjuvant treatment.