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Report for Clinical Trial NCT02091999
Developed by Shray Alag, 2020.
SNP Clinical Trial Gene
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.
NCT02091999 Metastatic Urothelial Cancer and Other Malignant Solid Tumors
1 Interventions
Name: enfortumab vedotin
Description: intravenous (IV) infusionType: Drug
Part A enfortumab vedotin Dose Escalation (Dose Levels 1-4) Part B enfortumab vedotin NSCLC Expansion Part B enfortumab vedotin Ovarian Cancer Expansion Part B enfortumab vedotin Renal Insufficiency Expansion Part C enfortumab vedotin CPI Treated Expansion
Primary Outcomes
Measure: Incidence of adverse events
Time: up to 36 months
Measure: Pharmacokinetic parameter for total antibody (TAb), antibody drug conjugate (ADC), and Monomethyl Auristatin E (MMAE): Concentration at the end of infusion (CEOI)
Time: Days 1-4, 8, 15-18 of Cycle 1 and Days 1, 8, and 15 of Cycle 2 and Day 1 of subsequent cycles up to an average of 24 months
Measure: Pharmacokinetic parameter for total antibody (TAb), antibody drug conjugate (ADC), and Monomethyl Auristatin E (MMAE): Maximum observed concentration (Cmax)
Time: Days 1-4, 8, 15-18 of Cycle 1 and Days 1, 8, and 15 of Cycle 2 and Day 1 of subsequent cycles up to an average of 24 months
Measure: Pharmacokinetic parameter for total antibody (TAb), antibody drug conjugate (ADC), and Monomethyl Auristatin E (MMAE): Trough concentration (Ctrough)
Time: Days 1-4, 8, 15-18 of Cycle 1 and Days 1, 8, and 15 of Cycle 2 and Day 1 of subsequent cycles up to an average of 24 months
Measure: Pharmacokinetic parameter for total antibody (TAb), antibody drug conjugate (ADC), and Monomethyl Auristatin E (MMAE): Time to maximum concentration (Tmax)
Time: Days 1-4, 8, 15-18 of Cycle 1 and Days 1, 8, and 15 of Cycle 2 and Day 1 of subsequent cycles up to an average of 24 months
Measure: Pharmacokinetic parameter for total antibody (TAb), antibody drug conjugate (ADC), and Monomethyl Auristatin E (MMAE): Partial area under the serum concentration-time curve after first dose and as appropriate (AUC0-7)
Time: Days 1-4, 8, 15-18 of Cycle 1 and Days 1, 8, and 15 of Cycle 2 and Day 1 of subsequent cycles up to an average of 24 months
Measure: Pharmacokinetic parameter for total antibody (TAb), antibody drug conjugate (ADC), and Monomethyl Auristatin E (MMAE): Terminal or apparent terminal half-life (t1/2)
Time: Days 1-4, 8, 15-18 of Cycle 1 and Days 1, 8, and 15 of Cycle 2 and Day 1 of subsequent cycles up to an average of 24 months
Measure: Pharmacokinetic parameter for total antibody (TAb), antibody drug conjugate (ADC), and Monomethyl Auristatin E (MMAE): Systemic clearance (CL)
Time: Days 1-4, 8, 15-18 of Cycle 1 and Days 1, 8, and 15 of Cycle 2 and Day 1 of subsequent cycles up to an average of 24 months
Measure: Pharmacokinetic parameter for total antibody (TAb), antibody drug conjugate (ADC), and Monomethyl Auristatin E (MMAE): Volume of distribution at steady state (Vss)
Time: Days 1-4, 8, 15-18 of Cycle 1 and Days 1, 8, and 15 of Cycle 2 and Day 1 of subsequent cycles up to an average of 24 months
Secondary Outcomes
Measure: Incidence of Anti-Drug Antibody (ADA)
Time: up to 24 months
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 months
Description: 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 months
Description: 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 months
Description: 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 months
Description: Time from the date of first infusion until the date of death from any cause.
Measure: Overall Survival
Time: 36 months
Description: 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 months
Purpose: Treatment
Allocation: Non-Randomized
Parallel Assignment
There is one SNP
SNPs
- 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 ---
HPO Nodes