Number of patients : Total 24 patients (6-12 patients in phase 1 part and 12 patients in expansion cohort )~Treatment :~Vactosertib* 100-300 mg bid for 5 days~Liposomal Irinotecan (Onivyde) 70mg/m2 on D1~LV 200mg/m2 IV bolus on D1~5-FU 2400mg/m2 CIV over 46 hours on D1~Vactosertib will be kindly provided by MedPacto.~Disease evaluation: Tumor assessment will be conducted at screening and before Day 1 of every third cycle starting with Cycle 4~Period : Approximately 24 months from the date of Institutional Review Board (IRB) approval~Primary endpoint : To determine recommended phase 2 dose and to evaluate the safety of vactosertib in combination with nal-IRI/FL in patients with metastatic pancreatic ductal adenocarcinoma (PDAC) who have failed first-line gemcitabine and nab-paclitaxel~Secondary endpoint :~Progression-Free Survival (PFS) (RECIST 1.1 criteria)~Overall Survival (OS)~Objective Response Rate (ORR) (RECIST 1.1 criteria)~Disease Control Rate (DCR) (RECIST 1.1 criteria)~Exploratory endpoint~Pharmacokinetic assessment: before treatment, post treatment 1.5h, 4.5h, and 8hPharmacodynamic assessment: to evaluate changes in the amount of p-SMAD in PBMC.~Biomarker analysis in pre-treated and post-treated tumor samples
To determine recommended phase 2 dose and to evaluate the safety of vactosertib in combination with nal-IRI/FL in patients with metastatic pancreatic ductal adenocarcinoma (PDAC) who have failed first-line gemcitabine and nab-paclitaxel