Study evaluation
Tumors, PD, tumor, SD
DISEASE, SECONDARY, TUMORS, TUMOR
The primary endpoint was the identification of DLT in cycle 1 and the number of patients with DLT. The MTD, RD, and recommended dosing schedules were estimated based on the primary endpoints. The secondary endpoints were safety, PK, and efficacy. Efficacy was assessed as complete response (CR), partial response (PR), stable disease (SD), progressive disease (PD), or not evaluable as an objective tumor assessment based on the Response Evaluation Criteria in Solid Tumors (RECIST) criteria (version 1.1). In addition, progression-free survival (PFS) was evaluated. If DLT occurred in one of three patients at each level in each cohort, another three patients were added to the relevant cohort/level; MTD was defined as the highest level with DLT occurring in ≤ one of six patients. The RD and recommended dosing schedule were determined by an independent DSMB based on a comprehensive evaluation.