Nanocell attack: new combo therapy takes on tough pancreatic cancer

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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. Exclusion Criteria: * 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.