A Phase I Study of MSB2311 in Advanced Solid Tumors

Exclusion Criteria

• •Pregnant or nursing females.
• •Any remaining AEs \> grade 1 from prior anti-tumor treatment as per CTCAE v4. 03, with exception of the residual hair loss;
• •Received a biologic G-CSF, GM-CSF or erythropoietin within 14 days prior to the first dose of study drug;
• •Subjects who had prior treatment with an anti-PD-L1 product
• •History of documented autoimmune disease except for autoimmune hypothyroidism and well-controlled Type 1 diabetes mellitus.
• •W/o autoimmune condition requiring systemic treatment with immunosuppressive medications within 14 days before the planned first dose of study drug.
• •Primacy central nervous system (CNS) malignancy or symptomatic CNS metastases are not allowed, with exceptions defined in protocol.
• •Major surgery within the 28-days from the screening
• •Subjects with idiopathic pulmonary fibrosis or unresolved active or chronic inflammatory pulmonary disease are excluded.
• •History of human immunodeficiency virus (HIV) infection, active hepatitis B or C. HBV carriers
• •History of primary immunodeficiency, stem cell or organ transplant, or previous clinical diagnosis of tuberculosis disease.
• •Clinically significant acute infections 4 weeks and any infection 2 weeks prior to the first dose administration.
• •Known allergies, hypersensitivity, or intolerance to protein-based therapies or with a history of any significant drug allergy
• •Subjects who experienced immunotherapy-related adverse events (irAE) grade ≥ 3, or who had to discontinue prior anti-PD-1 treatment due to irAEs of any grade.
• •Severe or uncontrolled cardiac disease requiring treatment as defined in protocol
• •Any other serious underlying medical, psychiatric, psychological, familial or geographical condition that, in the judgment of the investigator, might impair the subject's benefit from the trial treatment
• •Known history of hypersensitivity to any components of the MSB2311 product.