CEND-1 Injection (QLC12102) in Patients With Advanced Metastatic Pancreatic Ductal Adenocarcinoma

Inclusion Criteria:

• Age: 18 to 80 years old, male or female.

• Patients with histologically confirmed metastatic pancreatic ductal adenocarcinoma;

• The Eastern Cooperative Oncology Group (ECOG) score is 0 to 1.

• The life expectancy is no less than 12 weeks.

• According to the RECIST v1.1 evaluation criteria, the patient has at least onemeasurable lesion (exclude if there is only a target lesion located at a sitepreviously treated with radiation);

• The patient who is suitable for first-line treatment with a combined regimen ofpaclitaxel (albumin-bound type) and gemcitabine;

Exclusion Criteria:

• The patients who have been previously treated with chemotherapy or other drugs forpancreatic carcinoma, or who have been treated with other anti-cancer drugs,including chemotherapy, targeted therapy, immunotherapy, or biologics.

• The patients who are known to be allergic to the investigatinal drug (CEND-1analogue) or its any excipient;

• The 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;

• The patients with symptomatic CNS metastasis, leptomeningeal metastases, or spinalcord compression due to metastasis. However, the patients with symptomatic CNSmetastasis before first administration of the investigational drug, who is treatedand stable for no less than 4 weeks, and the systematic hormone (any dose) treatmenthas been stopped for over 2 weeks, can be enrolled;

• The patients with other active malignant tumors within 3 years before signing theICF. The cured skin basal cell carcinoma or squamous cell carcinoma, superficialbladder cancer, carcinoma in situ of the cervix, carcinoma in situ of the breastductal, and papillary thyroid cancer are excluded.

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

• The patients who participated in any other drug clinical trial and administrated theinvestigational drug within 4 weeks before first dose;