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news.ImClone Systems has reported that the initial stage of a series of Phase I/II clinical trials of IMC-A12, its anti-insulin-like growth factor-1 receptor monoclonal antibody, in children with relapsed or refractory solid malignancies, has commenced patient enrollment.
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The initial Phase I study, which will be performed by the Children’s Oncology Group (COG) Phase I Consortium that includes 20 clinical COG sites in North America, will determine the optimal dose, side effects, pharmacology, and biological effects of IMC-A12 administered intravenously once each week to children and adolescents with relapsed or refractory solid cancers. Up to 38 patients are expected to be enrolled. Immediately upon determination of a recommended pediatric Phase II dose for IMC-A12, the antitumor activity of IMC-A12 will be evaluated in a much larger Phase II study in a larger number of COG sites.
The Phase II study will evaluate the antitumor activity of IMC-A12 in multiple pediatric malignancies, including osteosarcoma, Ewing sarcoma/peripheral primitive neuroectodermal tumor (PNET), rhabdomyosarcoma, Wilms’s tumor, and others.
The Phase I study is the first of an initial stage of at least 10 Phase I and II clinical trials of IMC-A12 sponsored by the Cancer Therapy Evaluation Program of the Division of Cancer Treatment and Diagnosis, National Cancer Institute, to commence patient enrollment. In addition to the studies of IMC-A12 in pediatric patients with advanced malignancies, Phase II studies of IMC-A12 in patients with advanced prostate and colorectal cancers have begun to enroll patients.