A Study of CEND-1 With Chemotherapy as First-Line Therapy in Patients With Pancreatic Ductal Adenocarcinoma

Inclusion Criteria:

• 18~80 years old, male or female;

• Locally advanced unresectable or metastatic PDAC confirmed by histopathology orcytopathology;

• Patients who have not received prior systemic therapy for locally advanced ormetastatic 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 testfor females of childbearing potential within 7 days prior to first dosing. Male andfemale subjects of childbearing potential must agree to use highly effective methodof contraception during the entire course of the study and within 180 days after theend of the study.

• Subjects participate voluntarily and sign informed consent.

Exclusion Criteria:

• Concurrent use of other anticancer drugs, including chemotherapy, targeted therapy,immunotherapy, or biologics;

• The patients who are known to be allergic to the investigatinal drug or its anyexcipient;

• Patients with the following conditions: myocardial infarction, severe/unstableangina, NYHA grade 2 or above cardiac dysfunction, and clinically significantsupraventricular or ventricular arrhythmia requiring clinical intervention within 6months before signing the ICF;

• Patients with high risk for gastrointestinal bleeding or abdominal bleeding asassessed by the investigator, such as tumor invasion of the gastro duodenum fingerintestines, large blood vessels, etc.;

• Patients with symptomatic CNS metastasis, leptomeningeal metastasis, or spinal cordcompression due to metastasis.

• Patients with other active malignant tumors within 3 years before signing the ICF.Patients with cured skin basal cell carcinoma or squamous cell carcinoma, carcinomain situ of the cervix, carcinoma in situ of the breast ductal, and papillary thyroidcancer can be enrolled.

• Patients with human immunodeficiency virus (HIV) infection or known acquiredimmunodeficiency syndrome (AIDS), active hepatitis or co-infection with hepatitis Band C.

• Patients who require systemic antibiotics for ≥7 days within 4 weeks prior to firstdose, or unexplained fever >38.5°C prior during screening or before first dose;

• Patients who participated in any other clinical studies;

• Patients with a known history of psychoactive drug abuse, alcohol abuse, orsubstance abuse; History of definitive neurological or mental disorder, includingepilepsy or dementia;

• The patients with added risks associated with the study or may interfere with theinterpretation of study results as determined by the investigator, or deemedunsuitable by the investigator and/or sponsor.