Ignite Creation Date:
2024-05-06 @ 6:42 PM
Last Modification Date:
2024-10-26 @ 2:53 PM
Study NCT ID:
NCT05754853
Status:
RECRUITING
Last Update Posted:
2023-04-13
First Post:
2023-02-22
Brief Title:
A Study of MRG002 Versus Investigators Choice of Chemotherapy in the Treatment of Patients With HER2-positive Unresectable Advanced or Metastatic Urothelial Cancer
Sponsor:
Shanghai Miracogen Inc
Organization:
Shanghai Miracogen Inc
Study Overview
Official Title:
An Open-label Randomized Multi-center Phase III Clinical Study of MRG002 Versus Investigators Choice of Chemotherapy in the Treatment of Patients With HER2-positive Unresectable Locally Advanced or Metastatic Urothelial Cancer Previously Treated With Platinum-based Chemotherapy and PD-1PD-L1 Inhibitors
Status:
RECRUITING
Status Verified Date:
2023-04
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 primary objective of this study is to compare the overall survival OS and progression-free survival PFS between MRG002 and investigator selected chemotherapy in patients with HER2-positive unresectable locally advanced or metastatic urothelial cancer previously treated with platinum-based chemotherapy and PD-1PD-L1 inhibitors
Detailed Description:
This study aims to enroll 290 patients Participants will be randomly assigned to receive treatment of MRG002 or investigator selected chemotherapy in a 11 ratio The efficacy of MRG002 will be assessed by patients OS PFS and other indicators as compared to investigator selected chemotherapy Additionally this study will assess the pharmacokinetic profile immunogenicity safety tolerability and treatment compliance of MRG002
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None