A phase I study of q3W R1507, a human monoclonal antibody IGF-1R antagonist in patients with advanced cancer

3590 Background: Insulin-like growth factor receptor (IGF-1R) is a tyrosine kinase cell surface receptor overexpressed in cancer cells which mediates the mitogenic and anti-apoptotic actions of IGF, playing a key role in malignant transformation. The safety and pharmacokinetics of 3-weekly administration of R1507, a human monoclonal antibody selective for IGF-1R, were explored in this phase I dose escalation study in patients with advanced solid tumors or lymphomas. Materials and Methods: Multiple ascending doses of R1507 were administered as a 1 hour infusion every 3 weeks until the development of dose-limiting toxicity (DLT) or progressive disease. Inclusion criteria: ECOG PS 0–1, adequate hematologic, hepatic, and renal function, CD4 count >200/μl. Exclusion criteria: infection, immunosuppressive agents, diabetes mellitus, uncontrolled systemic disease, NYHA III/IV CHF. DLT defined as ≥ grade 2 hypersensitivity reaction; ≥ grade 3 non-hematologic toxicity; ≥ grade 2 cardiac toxicity; ≥ grade 3 hematolo...