A phase I, first-in-human study of argx-111, a monoclonal antibody targeting c-met in patients with solid tumors.

2580 Background: Dysregulation of the tyrosine kinase receptor c-Met, is associated with tumorigenesis, metastasis and progression via hepatocyte growth factor (HGF)-dependent or-independent mechanisms. Methods: ARGX-111, a monoclonal IgG1 SIMPLE Antibody glyco-engineered for enhanced ADCC properties (POTELLIGENT), is currently being investigated in a Phase 1 clinical trial (accelerated titration design) in patients with advanced solid tumors (NCT 02055066). Results: As of January 2015, 16 patients (median age: 59 years; prior chemotherapy/targeted therapies/biological therapies: 81%/44%/31%;) with tumors staining positive (> 50% of tumor cells) for c-Met by immunohistochemistry have been treated at 4 dose levels (0.3, 1, 3, and 10 mg/kg IV q3 weeks; n = 2, 2, 9, and 3, respectively) and received a total of 41 cycles (median = 2; range 1-9). Patients with different histologies were enrolled (5 upper GI, 3 RCC, 2 pancreas, 2 NSCLC, 2 cervix and 2 others). The most common drug-related adverse events (AE) we...