Ewing Sarcoma Clinical Trial
Official title:
Single Patient Expanded Access to Ganitumab for Metastatic Ewing Sarcoma
Despite improvements in outcomes for patients with localized Ewing sarcoma, patients with
relapsed metastatic Ewing sarcoma continue to have poor outcomes with current chemotherapy
options. A large body of preclinical data supports a role for IGF-1R inhibition in the
treatment of Ewing sarcoma.
More recently, clinical trials of IGF-1R monoclonal antibodies have demonstrated single-
agent activity in patients with relapsed Ewing sarcoma. Ganitumab (AMG 479) is a fully human
monoclonal antibody directed against IGF-1R. We are proposing this single-agent expanded
access IND to provide our patient the opportunity to benefit from this treatment after having
developed progressive disease after multiple lines of prior therapy.
Despite improvements in outcomes for patients with localized Ewing sarcoma, patients with
relapsed metastatic Ewing sarcoma continue to have poor outcomes with current chemotherapy
options. A large body of preclinical data supports a role for IGF-1R inhibition in the
treatment of Ewing sarcoma.
More recently, clinical trials of IGF-1R monoclonal antibodies have demonstrated single-
agent activity in patients with relapsed Ewing sarcoma. Ganitumab (AMG 479) is a fully human
monoclonal antibody directed against IGF-1R. We are proposing this single-agent expanded
access IND to provide our patient the opportunity to benefit from this treatment after having
developed progressive disease after multiple lines of prior therapy.
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