FL118 for Treating Patients With Advanced Pancreatic Ductal Adenocarcinoma

Inclusion Criteria: * Age ≥ 18 years old * Have a histologically or cytologically confirmed advanced PDAC (locally advanced/unresectable or metastatic for part A (dose escalation) and metastatic for part B (dose expansion) * Progression on or intolerance to 1st line therapy for advanced disease. Note that completion of adjuvant or neoadjuvant chemotherapy within 6 months from relapsed disease is considered one line of therapy for locally advanced/unresectable or metastatic disease * Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 * Have a life expectancy of greater than 3 months * Have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria present * Patient willing to undergo tumor biopsy at baseline and on treatment if there is a lesion that can safely be biopsied based on investigator assessment. If this is not feasible, adequate archival tumor tissue must be available * Absolute neutrophil count (ANC): ≥ 1,500/mL * Platelets: ≥ 100,000/mL * Hemoglobin: ≥ 9 g/dL * Creatinine clearance ≥ 60 mL/min (per Cockroft-Gault equation) * Total bilirubin: ≤ 1.5 X upper limit of normal (ULN) or, direct bilirubin ≤ ULN for subjects with total bilirubin levels \> 1.5 ULN * Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase \[SGOT\]) and alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SGPT\]): ≤ 2.5 X ULN or, ≤ 5 X ULN for subjects with liver metastases * Albumin: ≥ 3 gm/dL * …