CEND-1 in Combination With Nabpaclitaxel and Gemcitabine in Metastatic Pancreatic Cancer

Inclusion Criteria: * Patients with histologically confirmed metastatic pancreatic ductal carcinoma * One or more metastatic lesions measurable on MRI, PET/CT, or dedicated CT scan according to RECIST v1.1. * Eligible for treatment with nabpaclitaxel and gemcitabine * Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 * Life expectancy of at least 3 months * Adequate archival tissue from prior biopsy for biomarker evaluation or willingness to undergo biopsy before treatment starts * The patient is capable of understanding and complying with the protocol and the subject or, when applicable, the subject's legally acceptable representative has signed the informed consent * A negative serum pregnancy test (if a premenopausal female patient) * Acceptable liver function: Bilirubin ≥ 1.5 times upper limit of normal; AST (SGOT) \< 10 times upper limit of normal, ALT (SGPT) and Alkaline phosphatase 2.5 times upper limit of normal (if liver metastases are present, then ≤ 5 x ULN is allowed). * Acceptable renal function: Serum creatinine within normal limits; calculated creatinine clearance ≥ 60 mL/min/1.73 m2 for patients with creatinine levels above institutional normal by the Cockroft-Gault equation. * Acceptable hematologic status: Granulocyte ≥ 1500 cells/mm3; Platelet count ≥ 100,000 plt/mm3; Hemoglobin ≥ 9 g/dL. * Urinalysis: No clinically significant abnormalities. * Acceptable coagulation status: PT within normal limits; PTT within normal limits. * For men and women of child-producing potential, the use of effective contraceptive methods during the study. Exclusion Criteria: * Prior chemotherapy or any other investigational agents for the treatment of pancreatic cancer. * Concurrent use of any other anti-cancer therapy, including chemotherapy, targeted therapy, immunotherapy, or biological agents. * Participants with known brain metastases. * New York Heart Association Class III or IV, cardiac disease, myocardial infarction within the past 6 months, unstable arrhythmia, or evidence of ischemia on ECG. * Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy. * Pregnant or nursing women. Women of child-bearing potential and men must agree to use adequate contraception. * Unwillingness or inability to comply with procedures required in this protocol. * Known infection with HIV, hepatitis B, or hepatitis C. * Serious nonmalignant disease (e.g., hydronephrosis, liver failure, or other conditions per physician judgement) that could compromise protocol objectives in the opinion of the investigator and/or the sponsor.