Ignite Creation Date:
2024-05-06 @ 4:28 PM
Last Modification Date:
2024-10-26 @ 2:10 PM
Study NCT ID:
NCT04995419
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-06-27
First Post:
2021-08-02
Brief Title:
A Study to Evaluate Enfortumab Vedotin ASG-22CE in Chinese Participants With Locally Advanced or Metastatic Urothelial Cancer Who Previously Received Platinum-containing Chemotherapy and Programmed Cell Death Protein-1 PD 1 Programmed Death Ligand-1 PD-L1 Inhibitor Therapy
Sponsor:
Astellas Pharma China Inc
Organization:
Astellas Pharma Inc
Study Overview
Official Title:
A Single-arm Open-label Multi-center Phase 2 Study of Enfortumab Vedotin ASG-22CE in Chinese Subjects With Locally Advanced or Metastatic Urothelial Cancer Who Previously Received Platinum-containing Chemotherapy and PD 1PD-L1 Inhibitor Therapy EV-203
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study was to determine the antitumor activity of enfortumab vedotin EV confirmed by the objective response rate ORR
This study also evaluated the effect of antibody-drug conjugate ADC total antibody TAb and monomethyl auristatin E MMAE in Chinese participants with locally advanced or metastatic urothelial cancer
In addition the study also evaluated the duration of response DOR disease control rate DCR progression-free survival PFS overall survival OS and immunogenicity determined by the incidence of antitherapeutic antibodies ATA
Safety and tolerability of EV in participants with locally advanced or metastatic urothelial cancer was also evaluated
This study also evaluated the effect of antibody-drug conjugate ADC total antibody TAb and monomethyl auristatin E MMAE in Chinese participants with locally advanced or metastatic urothelial cancer
In addition the study also evaluated the duration of response DOR disease control rate DCR progression-free survival PFS overall survival OS and immunogenicity determined by the incidence of antitherapeutic antibodies ATA
Safety and tolerability of EV in participants with locally advanced or metastatic urothelial cancer was also evaluated
Detailed Description:
This study comprised of a single group of participants who received one dose of enfortumab vedotin EV on Days 1 8 and 15 of every 4-week 28 days cycle Participants continued on study treatment until discontinuation
After treatment discontinuation participant had an end of treatment EOT visit for a 30-day Safety Follow-up
Participants to discontinue to treatment for reasons other than disease progression were followed for response assessments
A Pharmacokinetic PK cohort was available at some study centers Participants enrolled at the PK cohort sites had intense PK samples collected after single and repeated doses
After treatment discontinuation participant had an end of treatment EOT visit for a 30-day Safety Follow-up
Participants to discontinue to treatment for reasons other than disease progression were followed for response assessments
A Pharmacokinetic PK cohort was available at some study centers Participants enrolled at the PK cohort sites had intense PK samples collected after single and repeated doses
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CTR20210922 | REGISTRY | chinadrugtrialsorgcn | None |