Safety of SNK01 in Subjects With Pathologically Confirmed Metastatic and/or Unresectable Cancer Refractory to Conventional Therapy

Exclusion Criteria

• •Pregnant and/or lactating females.
• •Life expectancy of less than three months.
• •Currently being treated by "biological therapy" as defined by the National Cancer Institute (example: checkpoint inhibitors, adoptive cell transfer, monoclonal antibodies, treatment vaccines, cytokines, Bacillus Calmette-Guerin (BCG), chimeric antigen receptor T cell therapy (CAR-T), and natural killer cell therapy).
• •Patients tested positive for hepatitis B and/or C surface antigen.
• •High fever or any active or unresolved infection, including human immunodeficiency virus (HIV) positive.
• •Autoimmune disease requiring therapy; immunodeficiency, or any disease process requiring immunosuppressive therapy.
• •Prior clinical trial requiring patient to receive an investigational drug within two weeks of enrollment.
• •Congestive heart failure, unstable angina or other underlying cardiac disease; history of thrombosis currently requiring anticoagulation.
• •Mental or psychological illness preventing cooperation with treatment, efficacy evaluations, or unable to understand the informed consent process.
• •Subjects who have undergone prior organ transplantation, including allogeneic stem-cell transplantation.
• •Adult subjects who lack capacity to consent for themselves and for whom consent must be provided by a legally authorized representative.
• •For SNK01+avelumab arm only: Subjects with prior hypersensitivity to avelumab or its excipients, including known severe hypersensitivity reactions to monoclonal antibodies (NCI CTCAE v4.03 Grade ≥ 3).
• •For SNK01+avelumab arm only: Subjects with a significant immune-mediated adverse event due to a prior checkpoint inhibitor immunotherapy that led to permanent discontinuation of the therapy.