Pilot Phase 2 Study to Investigate the Preliminary Efficacy and Safety of INNO-206 in Advanced Pancreatic Cancer

This is a phase 2 open-label, pilot study evaluating the preliminary efficacy and safety of INNO-206 administered at 350 mg/m2 (260 mg/m2 doxorubicin equivalent) intravenously (IV) on Day 1 every 21 days for up to 8 consecutive cycles. Tumor response (complete and partial response and stable disease) will be monitored at Screening, then prior to cycles 3, 5 and 7, 3 weeks after cycle 8, then every 2 months to month 8 and every 3 months to tumor progression using the Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria, and treatment will continue every 21 days until tumor progression is observed, 8 cycles of treatment are completed or unacceptable toxicity occurs. Progression-free survival \[PFS\], stable disease at 4 months and overall survival \[OS\] will be monitored as other primary objectives. PET/CT will be performed at Baseline and Week 9 to determine change in tumor metabolic activity, and CA 19-9 will be determined serially to assess potential tumor reduction. Subjects will visit the study site every 21 days for their IV infusions, at which time safety monitoring, including AEs, a directed physical examination, laboratory evaluations (serum chemistry, complete blood count \[CBC\], and urinalysis), vital signs, weight measurements, ECOG performance status and ECGs will be performed. Cardiac function will also be followed periodically using ECHOs.