A Phase 2 Study of ASONEP™ to Treat Unresectable and Refractory Renal Cell Carcinoma

Inclusion Criteria: * Unresectable, locally advanced recurrent or metastatic RCC * Histological or cytological confirmation of clear cell RCC - core tissue biopsy of either primary tumor or metastatic lesion with paraffin-embedded tissue specimens if no prior nephrectomy * Measurable disease by RECIST 1.1 * Had one prior therapy for unresectable RCC with a VEGF/VEGFR targeted therapy (sunitinib, sorafenib, other VEGFR TKI or bevacizumab) - One prior treatment with an mTOR inhibitor (everolimus, temsirolimus or sirolimus) for unresectable disease permitted-Prior immunotherapy (immunomodulators such as cytokines, interleukins, vaccines, etc.) such as IL-2 also permitted * Male or non-pregnant, non-nursing female * Life expectancy ≥3 months * ECOG performance status of 0, 1 or 2 * Must not be receiving any concurrent anticancer therapy * Baseline CT or MRI scans of measurable disease sites by RECIST 1.1 performed within 2 weeks of Day 0 - For subjects with bone metastases, baseline bone scan performed within 4 weeks of study entry * Adequate organ and immune function (within 7 days of Day 0): Hemoglobin \>9 g/dL-Absolute neutrophil count \>1500 cells/uL without growth factors-Platelet count ≥100x10\^9/L without transfusion-Serum creatinine \<2.0x ULN or creatinine clearance \>40 mL/min-Total bilirubin \<1.5x ULN-AST/ALT \<2.5x ULN (or \<5.0x ULN if liver metastases present)-INR and aPTT \<1.5x ULN * Subject lesions for arterial spin labeling (ASL) MRI ≥2.5cm by CT imaging * Must understand, be able and willing to fully comply with study procedures Exclusion Criteria: * Prior treatment with \>3 VEGF pathway and/or mTOR inhibitors for RC cancer * History of other CNS disease (spinal cord compression, or evidence of symptomatic brain or leptomeningeal carcinomatosis) * Major surgery within 4 weeks of Day 0 * Radiation therapy within 4 weeks of baseline/infusion. Prior palliative radiation to metastatic lesions is acceptable if there is at least one measurable, non-radiated lesion * Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection requiring parenteral antibiotics on Day 0 * Known or suspected intolerance or hypersensitivity to study materials or any excipients * Evidence of bowel obstruction because of theoretical possibility of GI perforation with an anti-angiogenesis agent * Severe hemorrhage within 4 weeks of screening * History of GI perforation * History of non-healing wounds including ulcer or delayed bone fractures * Prolonged QTc interval on baseline ECG (\>450 msec for males or \>470 msec for females), cardiac dysrhythmias including atrial fibrillation, torsade de pointes, ventricular tachycardia or fibrillation, pathologic sinus bradycardia (\<60 bpm), heart block (excluding 1st degree block, being PR interval prolongation only), congenital long QT syndrome or new ST segment elevation or depression or new Q wave on ECG * Secondary malignancy within the last 5 years, except for adequately-treated basal cell carcinoma, squamous cell skin cancer, superficial bladder tumors, or in situ cervical cancer * Previously enrolled in an sonepcizumab study or into this study and subsequently withdrawn * History of alcohol or other substance abuse within the last year * Use of corticosteroids or other immunosuppression (if taking systemic steroids \[vs. topical\], at least 4 weeks must have passed since the last dose) * Growth factors within 1 week of screening * Serious medical conditions that might be aggravated by treatment or limit compliance * Cerebrovascular accident or transient ischemic attack, or pulmonary embolism within 6 months prior to screening * Participation in another clinical trial * Other severe or intercurrent acute or chronic medical or psychiatric condition or laboratory abnormality that may increase risk associated with study participation or study drug administration