The Southwest Oncology Group (SWOG), a cancer network sponsored by the National Cancer Institute (NCI), is evaluating IMC-A12, ImClone’s fully human, IgG1 anti-insulin-like growth factor-1 receptor (IGF-1R) monoclonal antibody, in a small Phase I study immediately followed by a much larger randomized Phase II trial.
The initial 6-12 patient Phase I study will evaluate the side effects and recommend a dose of IMC-A12 administered in combination with gemcitabine and erlotinib, an approved regimen used to treat patients with advanced-stage pancreatic cancer. Immediately upon determination of a recommended Phase II dose for IMC-A12 combined with gemcitabine and erlotinib, a Phase II multicenter study will begin.
In the much larger Phase II study, previously untreated patients with advanced pancreatic cancer will be randomized to treatment with either IMC-A12 in combination with gemcitabine and erlotinib or the gemcitabine-erlotinib regimen without IMC-A12. Based on supportive preclinical data indicating favorable anticancer activity when IMC-A12 and inhibitors of the epidermal growth factor receptor, such as cetuximab and erlotinib, are combined, the principal objective of this Phase II study is to evaluate the efficacy of IMC-A12 plus gemcitabine and erlotinib.
In addition to this Phase II study of IMC-A12 in pancreatic cancer patients, Phase II studies of IMC-A12 in patients with advanced prostate, colorectal and liver cancers have begun to enroll patients, and a series of Phase I/II studies evaluating IMC-A12 in pediatric patients with advanced malignancies has opened for patient enrollment.