Phase I study of olaratumab in Japanese patients with advanced solid tumors

摘要: Olaratumab (IMC-3G3) is a fully human IgG1 monoclonal antibody that selectively binds the external domain of platelet-derived growth factor receptor-α with high affinity and blocks ligand binding. This was single-center, dose-escalation, phase I trial olaratumab in Japanese patients advanced/refractory solid malignancies. Three to six were enrolled into each three cohorts: Patients received i.v. olaratumab: 10 mg/kg on days 1 8 every 3 weeks (cohort 1); 20 2 2); 15 3). Doses escalated from cohort through 3. The primary objective establish safety pharmacokinetic profile olaratumab. Sixteen treated across cohorts. There no dose-limiting toxicities, so maximum tolerated dose not reached. most common olaratumab-related treatment-emergent adverse events (TEAEs) proteinuria (25.0%) elevated aspartate transaminase (12.5%). One patient 2) had two Grade TEAEs (increased aminotransferase tumor hemorrhage); otherwise, 1/2. Seven (43.8%) best response stable disease. Based concentration olaratumab, trough concentrations following single multiple doses at 3) above 155 μg/mL target. Thus, these could represent an acceptable schedule for future trials patients. well tolerated.