A Multicenter, Multinational Extension of Study CP-MGA031-01 to Evaluate the Long-Term Efficacy and Safety of Teplizumab (MGA031), a Humanized, FcR Non-Binding, Anti-CD3 Monoclonal Antibody, in Children and Adults with Recent-Onset Type 1 Diabetes Mellitus The primary objective of the extension study is to assess long-term safety, with particular focus on the development of serious adverse events (SAEs), adverse events of special interest (AESIs) includ...

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A Phase 3 Study of Margetuximab Plus Chemotherapy vs Trastuzumab plus Chemotherapy in the Treatment of Patients with HER2+ Metastatic Breast Cancer (SOPHIA). Estudio de Fase 3 de margetuximab más quimioterapia frente a trastuzumab más quimioterapia en pacientes con cáncer de mama metastásico HER2+ (SOPHIA) The primary objective of this study is to evaluate the efficacy, as measured by progression-free survival (PFS) assessed by independent review and overall survival (OS), of margetuximab plus chemothe...

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A Phase 2/3, Randomized, Double-Blind, Multicenter, Multinational, 4-Arm, Controlled, Dose-Ranging Study to Evaluate Efficacy and Safety of Teplizumab (MGA031), a Humanized, FcR Non-Binding, Anti-CD3 Monoclonal Antibody, in Children and Adults with Recent-Onset Type 1 Diabetes Mellitus The primary objective of this study is to assess, relative to placebo, the efficacy, tolerability, and safety of teplizumab when administered according to 3 different teplizumab dosing regimens in sub...

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