Metastatic Non-Familial Adenocarcinoma Maintenance Therapy With DZ-002: Heptamine Carboxymethine Dye Conjugate (DZ-002-201)

Histopathologically confirmed diagnosis of metastatic pancreatic adenocarcinoma who completed 4 months or more of first line chemotherapy and have achieved at least SD documented by CT scan.

Male or female patients ≥18 years of age;

Measurable or evaluable disease by RECIST v 1.1;

Capable of understanding and complying with protocol requirements;

A life expectancy of greater than 8 weeks at Screening;

ECOG PS of 0 to 1;

Written informed consent from the patient or the patient's legally acceptable representative prior to the initiation of any study procedures;

Adequate bone marrow, liver, and renal function as defined below:

1. Hemoglobin ≥ 10.0 g/dL (transfusions and/or erythropoietic stimulating growth factors allowed);
2. Absolute neutrophil count ≥ 1500/μL;
3. Platelet count ≥ 75,000/ μL;
4. Alanine aminotransferase and aspartate aminotransferase ≤ 2.5 × the upper limit of normal (ULN) or ≤ 5 × ULN for patients with known hepatic metastases;
5. Total serum bilirubin ≤ 1.5× ULN or ≤ 2 .0 × ULN if liver metastases are present. Patients with a known history of Gilbert's syndrome (≤ 3.0 × ULN)
6. Estimated creatinine clearance ≥ 40 mL/min (using the Cockcroft Gault formula);

Adequate cardiac function as estimated by left ventricular ejection fraction (LVEF) > 50% by multiple-gated acquisition (MUGA) or echocardiogram (ECHO);

Adequate pulmonary function tests with FEV 1 >90% and Vital capacity >90%