A Study of GB201 in Combination With Weekly Paclitaxel and Low-dose Gemcitabine in Patients With Pancreatic Cancer

Inclusion Criteria

• •1. Written, signed consent for trial participation in accordance with applicable ICH guidelines.
• •2. Must have histologically or cytologically confirmed advanced pancreatic adenocarcinoma that is metastatic.
• •3. Patients who are candidates for and have access to gemcitabine-nab-paclitaxel or are candidates for FOLFIRINOX/mFOLFIRINOX must have received these standard of care regimens before randomization.
• •4. Must have one or more evaluable metastatic tumors by RECIST 1.1.
• •5. Must have ECOG Performance Status of 0 or 1.
• •6. Must have life-expectancy of \> 12 weeks.
• •7. Must be ≥ 18 years of age.
• •8. For male or female patients of child producing potential: must agree to use contraception or take measures to avoid pregnancy.
• •9. Adequate biological parameters：
• •* Absolute neutrophil count (ANC) ≥ 1.5 × 10\^9/L
• •* Platelet count ≥ 100,000/mm\^3 (100 × 10\^9/L).
• •* Hemoglobin (Hgb) ≥ 9 g/dL.
• •* AST (SGOT) and ALT (SGPT) ≤ 2.5 × institutional upper limit of normal (ULN) \[5 ×ULN in presence of liver metastases\]
• •* Total bilirubin ≤ 1.5 × institutional ULN. If total bilirubin is \> ULN, it must be non-rising for at least 3 days.
• •* Serum creatinine within normal limits or calculated clearance \> 60 mL/min/1.73 m\^2.
• •10. Acceptable coagulation studies.
• •11. No clinically significant abnormalities on urinalysis.
• •12. Patient must have adequate nutritional status.
• •13. Pain symptoms should be stable (of tolerable Grade 2 or less).
• •14. Only patients with available archival tumor tissue must consent to submit block of tumor tissue.
• •15. The patient is not receiving therapy in a concurrent clinical study.