ImClone to Initiate Patient Enrollment in Phase II Sarcoma Study
ImClone Systems has announced that a Phase II clinical trial of IMC-A12, the company’s fully human, IgG1 anti-insulin-like growth factor-1 receptor monoclonal antibody, in adolescents and adult patients with several types of soft tissue sarcoma has opened for patient enrollment.
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.”