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

This is an interventional treatment trial for Neuroblastoma focused on measuring Neuroblastoma, Rhabdomyosarcoma, Osteosarcoma, Ewing Sarcoma, Wilms Tumor, Desmoplastic Small Round Cell Tumor, pediatric Read More

General Inclusion Criteria:

• Age at treatment 1 to 35 years.
• Relapsed or refractory malignant solid tumors of any histology for which no standard curative therapy is available (escalation phase).
• Histologically proven: neuroblastoma, rhabdomyosarcoma, osteosarcoma, Ewing's sarcoma/ primitive neuroectodermal tumor, Wilms tumor, desmoplastic small round cell tumor or malignant solid tumors of any other histology that test positive for B7-H3 .
• Must have malignant solid tumors that demonstrate B7-H3 expression at 2+ or greater levels on the membranous surface of at least 10% of tumor cells or ≥ 25% of tumor vasculature by IHC.
• With the exception of patients with non-measurable neuroblastoma patients must have measurable disease as per RECIST 1.1
• Karnofsky (patients ≥ 16 years)/Lansky (patients < 16 years) index ≥ 70.
• Acceptable laboratory parameters and adequate organ reserve.

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.