Endpoints
DLTs, neutropenia, febrile neutropenia, toxicity, toxicities, thrombocytopenia, Cancer
ADVERSE EVENT, NEUTROPENIA, FEBRILE NEUTROPENIA, THROMBOCYTOPENIA, EVENTS, BLEEDING REQUIRING TRANSFUSION, NEUTROPENIC INFECTION, CANCER
The primary endpoint was the incidence of DLTs that occurred during the first two 2-week cycles (4 weeks) in the Q2W-LD cohort and during the first 3-week cycle (3 weeks) in the Q3W cohort. The definition of a DLT used National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03 and included hematologic toxicities (e.g., grade 4 neutropenia lasting ≥7 days, febrile neutropenia or neutropenic infection; grade 4 thrombocytopenia or grade 3 thrombocytopenia with bleeding requiring transfusion); grade ≥3 non-hematologic toxicities; grade ≥2 cardiac conduction toxicities; and any tusamitamab ravtansine-related toxicity resulting in a treatment delay of >2 weeks due to delayed recovery to baseline or grade ≤1. Ocular events were considered DLTs if they were grade ≥3 or resulted in a treatment delay of >2 weeks due to delayed recovery to baseline or grade ≤1 (Secondary endpoints included the safety profile, pharmacokinetic profile, preliminary antitumor activity (per Response Evaluation Criteria in Solid Tumours [RECIST] version 1.1), and potential immunogenicity of tusamitamab ravtansine in the Q2W-LD and Q3W cohorts.