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

NCT05754853 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 290

Last updated 2023-04-13

No results posted yet for this study

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.

Conditions

  • Advanced or Metastatic Urothelium Cancer

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

Sponsors & Collaborators

  • Shanghai Miracogen Inc.

    lead INDUSTRY

Principal Investigators

  • Aiping Zhou, MD · Cancer Institute and Hospital, Chinese Academy of Medical Sciences

  • Fangjian Zhou, MD · Sun Yat-sen University Cancer Prevention Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-04-06
Primary Completion
2025-10-31
Completion
2027-01-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05754853 on ClinicalTrials.gov