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

Prior treatment

• 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.
• Concurrent unstable diabetes mellitus or other contraindications for the use of corticosteroids that requires active titration of insulin.
• 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:

Other illness

• 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%.
• 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.
• 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.
• Known allergy/hypersensitivity to investigational components or excipients (trehalose, monoclonal antibody infusions, interferon therapy, or ciprofloxacin HCl (or other quinolones).
• 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.

Lab values

• 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.
• 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.

Other

• Significant pericardial effusions, pleural effusions, or ascites that requires intervention. Subjects who require drainage within the last four weeks are ineligible.
• Baseline QTcF ≥ 450 ms (males) or ≥ 470 ms (females).
• Uncontrolled hypercalcemia (\>2.6mmol/L or \>10.3mg/dL) or symptomatic hypercalcemia requiring continued treatment for hypercalcemia.
• 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.

• Histological or pathological confirmation of metastatic pancreas adenocarcinoma. Cytological or histological evidence of metastatic disease is required.
• Male or Female greater than or equal to 18 years of age.
• Eastern Cooperative Oncology Group (ECOG) performance score of 0-1.
• Life expectancy ≥ 3 months in the opinion of the Investigator.
• Measurable disease as per iRECIST criteria.
• Subjects must have tumors that express EGFR.
• Documented disease progression with first line FOLFIRINOX or NALIRIFOX therapy, during or within 3 months (+/- 15 days) after end of therapy.
• No more than one line of prior systemic therapy for metastatic PDAC allowed.
• Albumin level \> 3.0 g/dl
• Adequate hematological function.
• Adequate renal function.
• Adequate hepatic function.
• Adequate cardiac function with LVEF ≥ 50% at baseline.
• Reproductive criteria as follows:
• Female subjects who are of non-reproductive potential
• Female subjects of childbearing potential must have a negative serum pregnancy test within 14 days of the first dose.
• Female subjects must be willing to use highly effective methods of birth control during the period of therapy and for 6 months following the last study drug administration.
• Male subjects must be willing to use highly effective methods of birth control during the period of therapy and for 6 months following the last study drug administration.
• All study subjects must be willing to ensure that corresponding sexual partners practice these same methods of highly effective birth control for the same duration.
• The subject (or subject's legally authorized representative) has provided voluntary signed informed consent.
• According to the investigator's assessment, subject will be able to comply with the study protocol.