A Phase II, Randomized, Double-blind, Multi-center, Placebo-Controlled Study of the Efficacy and Safety of CEND-1 in Combination With Chemotherapy as First-Line Therapy in Patients With Locally Advanced Unresectable or Metastatic Pancreatic Ductal Adenocarcinoma
The purpose of this study is to evaluate the efficacy and safety of CEND-1 in combination with gemcitabine/nab-paclitaxel versus gemcitabine/nab-paclitaxel and placebo as first-line treatment in patients with Locally Advanced Unresectable or Metastatic Pancreatic Ductal Adenocarcinoma.
• 18\
⁃ 80 years old, male or female;
• Locally advanced unresectable or metastatic PDAC confirmed by histopathology or cytopathology;
• Patients who have not received prior systemic therapy for locally advanced or metastatic pancreatic cancer;
• Patients with at least one measurable tumor lesion per RECIST v1.1;
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
• Expected survival time ≥ 12 weeks;
• Patients who have adequate organ function;
• Female subjects who are not pregnant or not breastfeeding. A negative pregnancy test for females of childbearing potential within 7 days prior to first dosing. Male and female subjects of childbearing potential must agree to use highly effective method of contraception during the entire course of the study and within 180 days after the end of the study.
• Subjects participate voluntarily and sign informed consent.