Enoblituzumab (MGA271) in Children With B7-H3-expressing Solid Tumors

Exclusion Criteria

• •Patients are to be excluded from the study if they have any of the following:
• •Patients with a history of symptomatic central nervous system (CNS) unless they have been treated and are asymptomatic.
• •Patients with any history of known or suspected autoimmune disease with the specific exceptions of vitiligo, resolved childhood atopic dermatitis, psoriasis not requiring systemic treatment within the past 2 years, and patients with a history of Grave's disease that are now euthyroid clinically and by laboratory testing.
• •History of prior allogeneic bone marrow/stem-cell or solid organ transplantation.
• •Patients receiving autologous stem cell transplantation must wait 8 weeks before initiation of study drug administration.
• •Treatment with systemic chemotherapy or investigational therapy within 4 weeks of first study drug administration; other agents (e.g., biologics) within 2 weeks; radiation within 2 weeks; patients receiving 131I-MIBG therapy must wait 6 weeks prior to the initiation of study drug administration; corticosteroids (≥ 0.2 mg/kg/day prednisone or equivalent) or other immune suppressive drugs within the 2 weeks prior to the initiation of study drug administration.
• •History of clinically significant cardiovascular disease
• •Active viral, bacterial, or systemic fungal infection requiring parenteral treatment within 7 days prior to the initiation of study drug.
• •Known positive testing for human immunodeficiency virus or history of acquired immune deficiency syndrome.
• •Known history of hepatitis B or hepatitis C infection or known positive test for hepatitis B surface antigen, hepatitis B core antigen, or hepatitis C polymerase chain reaction.
• •Second primary invasive malignancy that has not been in remission for greater than 2 years.
• •History of severe trauma or major surgery within 4 weeks prior to the initiation of study drug administration.
• •Known hypersensitivity to recombinant proteins, polysorbate 80 or any excipient contained in the drug formulation for enoblituzumab
• •Patients in Canada may not have a history or evidence of latent or active tuberculosis infection.