Phase 2 Study of IMC-A12 for Advanced Soft Tissue Sarcoma Opens for Patient Enrollment
News Jul 08, 2008
ImClone Systems Incorporated has announced that a Phase 2 clinical trial of IMC-A12, ImClone’s fully human, IgG1 anti-insulin-like growth factor-1 receptor (IGF-1R) monoclonal antibody, in adolescents and adult patients with several types of soft tissue sarcoma has opened for patient enrollment.
“This Phase 2 study of IMC-A12 builds on a biological rationale that suggests that the insulin-like growth factor receptor may confer a treatment advantage to these unique cancers versus conventional chemotherapy agents which often induce less than optimal results,” said Eric K. Rowinsky, M.D., Chief Medical Officer and Executive Vice President of ImClone.
This multinational Phase 2 study will evaluate the efficacy of IMC-A12 in adult and adolescent (age = 12 years) 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 (PNET), rhabdomyosarcoma; leiomyosarcoma; adipocytic sarcoma, and synovial sarcoma.
Based on supportive preclinical and biological rationale indicating that the IGF-1R and related signaling pathways may be overstimulated in these tumor types, and therefore particularly sensitive to IMC-A12, the primary objective of this Phase 2 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.
“ImClone is making considerable progress in advancing the clinical development of IMC-A12 and the other novel antibodies in our proprietary pipeline,” said John H. Johnson, Chief Executive Officer of ImClone. “This study in particular highlights ImClone’s commitment to developing biologic therapies to treat all types of cancer in both adult and pediatric patients.”
IMC-A12 is a fully human IgG1 monoclonal antibody. It is designed to specifically target the human IGF-1R, thereby inhibiting certain ligands known as IGFs 1 and 2 from binding to and activating the receptor. This action blocks a signaling pathway that enhances tumor cell proliferation and survival.
In addition to this Phase 2 study of IMC-A12 in adult and adolescent patients with soft tissue sarcoma, Phase 2 studies of IMC-A12 in patients with advanced prostate, pancreatic, colorectal, liver, and head and neck cancers, as well as a series of Phase 1/2 studies in pediatric malignancies and another evaluating the combination of IMC-A12 and temsirolimus, have begun to enroll patients.