Clinical Trials Directory

Trials / Recruiting

RecruitingNCT05754853

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

Status
Recruiting
Phase
Phase 3
Study type
Interventional
Enrollment
290 (estimated)
Sponsor
Shanghai Miracogen Inc. · Industry
Sex
All
Age
18 Years – 75 Years
Healthy volunteers
Not accepted

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.

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 1:1 ratio. The efficacy of MRG002 will be assessed by patient's 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.

Conditions

Interventions

TypeNameDescription
DRUGMRG002Administrated intravenously
DRUGDocetaxel InjectionAdministrated intravenously
DRUGPaclitaxel InjectionAdministrated intravenously
DRUGGemcitabine Hydrochloride for InjectionAdministrated intravenously
DRUGPemetrexed Disodium InjectionAdministrated intravenously

Timeline

Start date
2023-04-06
Primary completion
2025-10-01
Completion
2027-01-01
First posted
2023-03-06
Last updated
2023-04-13

Locations

1 site across 1 country: China

Source: ClinicalTrials.gov record NCT05754853. Inclusion in this directory is not an endorsement.