Phase I And Pharmacokinetic Study Of Farletuzumab In Solid Tumors.

3084 Background: Farletuzumab (F) is a humanized monoclonal antibody against folate receptor α (FRA). Expression of FRA is reported to be 90% and 40% in ovarian cancer (OC) and gastric cancer (GC), respectively. The purpose of the study is to assess tolerability, pharmacokinetic profile and preliminary antitumor effect in solid tumors. Methods: Patients with OC or FRA expressing solid tumor who are resistant to standard treatments are eligible in the study. After pharmacokinetic (PK) run-in, F was administered by IV injection repeating every week until disease progression. PK profile was analyzed on day1 to day 10 in PK run-in and on day 22 to 29 in cycle 1. Dose limiting toxicities (DLTs) were defined as G4 hematological and G3/4 non-hematological toxicities by NCI-CTCAE. Dose escalation was planed in 4 cohorts (50, 100, 200 and 400mg/m2). Results: Sixteen patients (14 OC and 2GC) received F infusion. Neither DLTs nor G3/4 toxicities were reported in all cohorts. As adverse events, G1/2 infusion reaction...