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news.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 patients with advanced liver cancer has opened for patient enrollment.
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This study is being carried out at the Memorial Sloan Kettering Cancer Center located in New York. This study is a component of an initial stage of at least 10 Phase I and II clinical trials of IMC-A12 sponsored by the Cancer Therapy Evaluation Program (CTEP) of the Division of Cancer Treatment and Diagnosis (DCTD), National Cancer Institute, to commence patient enrollment.
This study is enrolling patients with advanced, inoperable hepatocellular cancer (liver cancer) who have not received prior systemic therapy except for sorafenib tosylate. Patients may have received prior local therapy such as surgery, radiofrequency ablation, radiotherapy, and percutaneous intratumoral treatment. Up to 50 patients are expected to be enrolled.
The primary objective of this Phase II study is to determine the efficacy of IMC-A12 in this patient population. The study is also designed to ascertain information on the safety and biological behavior of the IGF-1R and IMC-A12 administered weekly by intravenous infusion.
Eric Rowinsky, chief medical officer and executive vice president of ImClone, said: “This study represents the first study of an IGF-1R inhibitor ever undertaken in patients with liver cancer.”