The purpose of this study is to evaluate the safety and pharmacokinetics of enfortumab vedotin as well as assess the immunogenicity and antitumor activity in subjects with metastatic urothelial cancer and other malignant solid tumors that express Nectin-4.
Name: enfortumab vedotin
Description: Incidence of tumor response defined as either a complete response (CR) or partial response (PR) per Response Evaluation Criteria in Solid Tumors (RECIST) criteria (version 1.1) that is confirmed ≥ 28 days later
Measure: Tumor response Time: up to 24 monthsDescription: Defined as the percentage of subjects who experience a best response of either CR or PR in that cohort. CR and PR must be confirmed ≥ 28 days later.
Measure: Objective response rate Time: up to 24 monthsDescription: Defined as the percentage of subjects who experience a best response of CR, PR or stable disease (SD)
Measure: Disease control rate Time: up to 24 monthsDescription: Time from the date of first infusion to the earliest date of documented disease progression per radiological evidence or death from any cause
Measure: Progression Free Survival (PFS) Time: 36 monthsDescription: Time from the date of first infusion until the date of death from any cause.
Measure: Overall Survival Time: 36 monthsDescription: Time from the date of the first response complete response (CRC) or partial response (PR) to the earliest date of disease progression or death from any cause. DOR is only defined for subjects who have best overall response of CR or PR
Measure: Duration of Response Time: 36 monthsAllocation: Non-Randomized
Parallel Assignment
There is one SNP
- Any P-glycoprotein (P-gp) inducers/inhibitors or strong cytochrome P4503A (CYP3A) inhibitors within 14 days prior to the first dose of study drug - Thromboembolic events and/or bleeding disorders ≤ 14 days (e.g., deep vein thrombosis (DVT) or pulmonary embolism (PE)) prior to the first dose of study drug - Documented history of a cerebral vascular event (stroke or transient ischemic attack), unstable angina, myocardial infarction, or cardiac symptoms (including congestive heart failure) consistent with New York Heart Association Class III-IV within 6 months prior to the first dose of enfortumab vedotin. --- P4503A ---