RecruitingPhase 3NCT05754853

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

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


Sponsor

Shanghai Miracogen Inc.

Enrollment

290 participants

Start Date

Apr 6, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Docetaxel Injection, a drug called Gemcitabine Hydrochloride for Injection, and others for people with advanced or metastatic urothelium cancer. The study is currently recruiting participants at 1 location. People eligible for this study include aged 18 Years to 75 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGMRG002

Administrated intravenously

DRUGDocetaxel Injection

Administrated intravenously

DRUGPaclitaxel Injection

Administrated intravenously

DRUGGemcitabine Hydrochloride for Injection

Administrated intravenously

DRUGPemetrexed Disodium Injection

Administrated intravenously


Locations(1)

Cancer Hospital Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, China

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NCT05754853