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-1/PD-L1 inhibitors.
1. Willing to sign the ICF and follow the requirements specified in the protocol.
1. History of hypersensitivity to any component of MRG002 or history of hypersensitivity of ≥ Grade 3 to trastuzumab.
Parallel
MRG002
DrugAdministrated intravenously
Docetaxel Injection
DrugAdministrated intravenously
Paclitaxel Injection
DrugAdministrated intravenously
Gemcitabine Hydrochloride for Injection
DrugAdministrated intravenously
Pemetrexed Disodium Injection
DrugAdministrated intravenously
Overall Survival (OS)
OS is defined as the time from the date of randomization until death of any cause.
Progression-Free Survival (PFS) by Independent Review Committee (IRC)
PFS is defined as the duration from the date of randomization to the onset of tumor progression or death of any cause.
Objective Response Rate (ORR)
ORR is defined as the percentage of patients with a complete response (CR) or partial response (PR) according to RECIST v1.1.
Duration of Response (DoR)
DoR is defined as the time from first documented objective response (CR/PR) to the first onset of tumor progression or death of any nonsurgical cause.
Disease Control Rate (DCR)
DCR is defined as the percentage of patients who achieve CR, PR, and stable disease (SD).
Clinical Benefit Rate (CBR)
CBR is defined as the percentage of patients who achieve CR, PR, and SD for ≥ 6 months.
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