C5731006 - A PHASE 1B/2, OPEN-LABEL, MULTICOHORT STUDY OF DISITAMAB VEDOTIN IN ADULTS WITH HER2 EXPRESSING ADVANCED BREAST CANCER

Condition studied

HER2 Expressing Advanced Breast Cancer

Investigational medicinal product(s)

Eligibility

Primary endpoint

Objective response (OR) (confirmed complete response [CR] and confirmed partial response [PR]) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) by investigator assessment.

Endpoint detail

Duration of response (DOR) per RECIST v1.1 by investigator assessment., Disease control rate (DCR) (confirmed CR, confirmed PR, and stable disease) per RECIST v1.1 by investigator assessment., Progression-free survival (PFS) per RECIST v1.1 by investigator assessment., Overall survival (OS)., Estimates of selected PK parameters of disitamab vedotin, total antibody, and unconjugated MMAE., Incidence of anti-drug antibodies (ADA) against disitamab vedotin., Safety (type, incidence, severity, seriousness, and relatedness of adverse events [AEs]. Type, incidence, and severity of laboratory abnormalities as well as significant changes from baseline. Frequency of treatment interruptions, dose reductions, and treatment discontinuation due to AEs).