Study Design
SOLID TUMORS
Study 120 was an open-label phase Ib/II study of E7389-LF plus nivolumab in patients with advanced, nonresectable, or recurrent solid tumors. The primary objectives of the phase Ib part of Study 120 were to determine the safety, tolerability, and the RP2D of E7389-LF plus nivolumab. Secondary objectives of the phase Ib part included assessment of the pharmacokinetics of E7389-LF plus nivolumab. The key exploratory objectives of the phase Ib part were to assess ORR and explore potential biomarkers. E7389-LF plus nivolumab was administered to four cohorts comprising two dosing schedules (either every 3 weeks, on day 1 of a 21-day cycle, or every 2 weeks, on days 1 and 15 of a 28-day cycle) and two different doses of study drugs per schedule, both administered intravenously. These cohorts were: (i) E7389-LF 1.7 mg/mThe two lower doses of E7389-LF in our study (1.7 mg/m