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

ConditionAdvanced or Metastatic Urothelium Cancer

Trial statusRecruiting

Trial phasePhase 3

Trial typeInterventional

Biological sexAll

Age18-75

SponsorShanghai Miracogen Inc.

About this trial

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 criteria

Qualifiers

1. Willing to sign the ICF and follow the requirements specified in the protocol.

Disqualifiers

1. History of hypersensitivity to any component of MRG002 or history of hypersensitivity of ≥ Grade 3 to trastuzumab.

Trial design

Treatments tested in this trial

MRG002
Docetaxel Injection
Paclitaxel Injection
Gemcitabine Hydrochloride for Injection
Pemetrexed Disodium Injection

Treatment groups

290 Participants

are divided into 2 treatment groups

Sponsors and collaborators

Shanghai Miracogen Inc.

Lead sponsor

Source ClinicalTrials.gov