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RECRUITING
NCT05754853
PHASE3

A Study of MRG002 Versus Investigator's Choice of Chemotherapy in the Treatment of Patients With HER2-positive Unresectable Advanced or Metastatic Urothelial Cancer

Sponsor: Shanghai Miracogen Inc.

View on ClinicalTrials.gov

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-1/PD-L1 inhibitors.

Official title: An Open-label, Randomized, Multi-center, Phase III Clinical Study of MRG002 Versus Investigator's 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-1/PD-L1 Inhibitors

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

290

Start Date

2023-04-06

Completion Date

2027-01

Last Updated

2023-04-13

Healthy Volunteers

No

Interventions

DRUG

MRG002

Administrated intravenously

DRUG

Docetaxel Injection

Administrated intravenously

DRUG

Paclitaxel Injection

Administrated intravenously

DRUG

Gemcitabine Hydrochloride for Injection

Administrated intravenously

DRUG

Pemetrexed Disodium Injection

Administrated intravenously

Locations (1)

Cancer Hospital Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, China