This multinational Phase II study will evaluate the efficacy of IMC-A12 in adult and adolescent patients with several types of previously treated, advanced or metastatic soft tissue sarcoma, which were selected based on the potential relevance of IGF-1R to tumor growth. Up to 185 patients are expected to be enrolled.
Patients with the following types of soft-tissue sarcoma are eligible for study enrolment: Ewing’s sarcoma, peripheral neuroectodermal tumor, rhabdomyosarcoma; leiomyosarcoma; adipocytic sarcoma, and synovial sarcoma.
The primary objective of this Phase II study is to evaluate the efficacy of IMC-A12 in adults and adolescents with the aforementioned subtypes of soft tissue sarcoma. The study will also characterize the safety of IMC-A12 as a single agent administered on an every-two-week schedule.
John Johnson, CEO of ImClone, said: “This study in particular highlights ImClone’s commitment to developing biologic therapies to treat all types of cancer in both adult and pediatric patients.”