A phase I study of AVE1642, a humanized monoclonal antibody IGF-1R (insulin like growth factor1 receptor) antagonist, in patients(pts) with advanced solid tumor(ST)

3582 Background: AVE1642, a humanized mAb, binds the human IGF1R specifically and with high affinity (Kd<1nM). It delays growth of cancer cells in vitro and of human tumors xenografted to nude mice. Materiel and Methods: this study aims to select the dose of AVE1642 to be combined with docetaxel 75 mg/m2 (D). AVE1642 was administered as single agent at cycle(cy)1 and then in combination with D from cy2, q3w. Sequential tumor biopsies were performed in a subset of pts. Main eligibility criteria: ≥ 18y.o; measurable or evaluable advanced ST; PS ≤2; HbA1c≤7.5% or FPG≤160mg/dL. PK/PD: blood was collected at d1, d2, d8, d15 and d22 cy1 and cy2 and at d22 of each subsequent cy. Selection of the dose is based on safety (<33% pts with DLT) and on PK, PD parameters. Results: as of 20-Dec-07, 14 pts (4 at 3mg/kg; 4 at 6mg/kg; 4 at 12mg/kg; 2 at 18mg/kg) received 49cy, including 35cy with T. Safety: No DLT/related SAE were reported so far. Gr1/2 related AEs: hyperglycemia(1), hypersensitivity reactions (2), asthenia...