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.