A Clinical Trial to Evaluate EDV Nanocell Therapy With Gemcitabine and Nab-paclitaxel in Pancreatic Cancer

Exclusion Criteria28

• Subjects currently receiving any other investigational agent.
• Unresolved (≥ Grade 1) non-hematological adverse events from prior anti-cancer therapy that is not controlled on maximal supportive therapy.
• Significant pericardial effusions, pleural effusions, or ascites that requires intervention. Subjects who require drainage within the last four weeks are ineligible.
• History of leptomeningeal or brain/CNS metastases.
• Ongoing treatment for other malignancies (hormone therapy acceptable).
• Patient may not have a history of malignancy other than PDAC within two years prior to screening except in circumstances where the risk of recurrence, metastasis or death in 5-years is \<10%.
• Concurrent unstable diabetes mellitus or other contraindications for the use of corticosteroids that requires active titration of insulin.
• Subject has experienced a history of uncontrolled coronary artery disease, with or without angina pectoris or myocardial infarction, symptomatic congestive heart failure (New York Heart Association \> Class II)
• Uncontrolled hypertension (systolic \> 180 mmHg or diastolic \> 100 mmHg) within two weeks.
• Uncontrolled cardiac arrhythmias requiring anti-arrhythmic therapy within the last four weeks.
• Baseline QTcF ≥ 450 ms (males) or ≥ 470 ms (females).
• Uncontrolled HIV infection. Patients without a prior diagnosis of HIV infection will undergo HIV testing unless not permitted to do so under local regulations. Patients with known HIV who have controlled infection (viral load undetectable and a CD4 count \>350 either spontaneously or on a stable antiviral regimen) are permitted.
• Uncontrolled Hepatitis B virus (HBV) infection (chronic or acute).
• Uncontrolled Hepatitis C virus (HCV) infection.
• Uncontrolled arterial or venous thrombosis.
• Active or uncontrolled severe infection.
• Uncontrolled hypercalcemia (\>2.6mmol/L or \>10.3mg/dL) or symptomatic hypercalcemia requiring continued treatment for hypercalcemia.
• Received the following procedures within 21 days to receiving their first dose (or has not recovered from the toxic effects of such therapy) including:
• other investigational therapy
• radiotherapy
• any major surgery.
• Prior other therapies or procedures prior to receiving their first dose:
• QTc interval prolonging medicines should be reviewed and where possible their use should be minimized and alternate medicines that are not QTc interval prolonging, considered as substitutes.
• Known allergy/hypersensitivity to investigational components or excipients (trehalose, monoclonal antibody infusions, interferon therapy, or ciprofloxacin HCl (or other quinolones).
• Female who is pregnant or breastfeeding.
• Subject who cannot comply with protocol scheduled study visits or procedures, to the best of the subject and Investigator's knowledge.
• Any kind of disorder that, in the opinion of the Investigator, may compromise the ability of the subject to give written informed consent and/or to comply with all required study procedures.
• History or evidence of any other clinically significant disorder, condition, or disease (except for those outlined above) that, in the opinion of the Investigator would pose a risk to subject safety or interfere with the study evaluation, procedures or completion.