Study of Nab-Paclitaxel and Gemcitabine With or Without SBP-101 in Pancreatic Cancer

Exclusion Criteria

• •When results of germline or somatic testing done prior to screening are known, subjects known to have mutations of the BRCA 1/2 (Breast Cancer gene) are excluded.
• •Concomitant metformin administration. Diabetic subjects on treatment with metformin, or any other derivative thereof, must discontinue it at least 5 days prior to C1D1 and not take metformin while on study (other diabetic medications are allowed).
• •Any history of retinopathy or at risk for retinal detachment (personal or family history of retinal detachment, extreme myopia \[-6.0 diopters or approximately 20/500\], eye surgery \<6 months prior to C1D1, or history of a severe eye injury. Subjects with findings of retinopathy on baseline ophthalmology exams will be excluded.
• •Evidence of severe or uncontrolled systemic disease or any concurrent condition that, in the opinion of the Investigator or Medical Monitor, makes it undesirable for the subject to participate in the study or that would jeopardize compliance with the protocol. Subjects with pre-existing well-controlled diabetes are not excluded.
• •Medical or psychiatric conditions that compromise the subject's ability to give informed consent or to complete the protocol or a history of non-compliance.
• •Presence of islet-cell or pancreatic neuroendocrine tumor or mixed adenocarcinoma-neuroendocrine carcinoma.
• •Symptomatic central nervous system (CNS) malignancy or metastasis. Screening of asymptomatic subjects without history of CNS metastases is not required.
• •Serum albumin \< 30 g/L (3.0 g/dL).
• •Deep vein thrombosis (DVT) or portal vein occlusion, pulmonary embolism (PE), or other thromboembolic event that occurs during screening.
• •Presence of known active bacterial, fungal, or viral infection requiring systemic therapy.
• •Known active infection with human immunodeficiency virus (HIV), hepatitis B or C.
• •Presence of interstitial lung disease, pulmonary fibrosis, or pulmonary hypersensitivity reaction.
• •Myocardial infarction within the last 12 months, severe/unstable angina, symptomatic congestive heart failure New York Heart Association (NYHA) class III or IV.
• •Pregnant or lactating.
• •Major surgery within 4 weeks prior to the start of study drug treatment, without complete recovery.
• •Known hypersensitivity to any component of study treatments.
• •Participation in any other clinical investigation within 4 weeks of receiving the first dose of study drug.
• •Any history of hydroxychloroquine use (Plaquenil® and other brand names).