Phase I, dose-escalation study of BIIB022 (anti-IGF-1R antibody) in advanced solid tumors.

2612 Background: The IGF pathway is believed to play a key role in the pathogenesis of several tumors. BIIB022 is a human, nonglycosylated IgG4 monoclonal antibody that binds to IGF-1R and blocks IGF-1 and IGF-2 binding. Methods: A phase I study is ongoing to evaluate the safety of escalating doses of BIIB022 given IV q3wk until progression or unacceptable toxicity in patients (pts) with advanced solid tumors. Efficacy, PK, PET imaging, and biomarkers are also being evaluated. Results: 24 pts received BIIB022 at doses of 1.5-30 mg/kg. The median age was 59.5 yrs. All pts had an ECOG PS £1. Tumor types were sarcoma (10), colorectal (8), lung (3), pancreas (2), adrenal (1). All pts had at least 1 AE; 16 had related AEs. The most common (≥10% of pts) related AEs were headache, fatigue, and nausea. Most related AEs were ≤Grade 2. 4 pts had Grade 3 related AEs (hypertension, fatigue, dyspnea, QTc interval prolongation); 0 had Grade 4 related AEs. Two pts had AEs that met the DLT criteria (AEs ≥Grade 3 within t...