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.
A PHASE3 clinical study on Advanced or Metastatic Urothelium Cancer, this trial is actively recruiting participants. The trial is conducted by Shanghai Miracogen Inc. and has accumulated 5 data snapshots since 2023. Oncology trials at this stage typically focus on safety, tolerability, and early efficacy signals.
Study Description(click to expand)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.
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.
Status Flow
Change History
5 versions recorded-
Jan 2026 — Present [monthly]
Recruiting PHASE3
-
Sep 2024 — Present [monthly]
Recruiting PHASE3
-
Jul 2024 — Sep 2024 [monthly]
Recruiting PHASE3
-
May 2023 — Jul 2024 [monthly]
Recruiting PHASE3
Status: Not Yet Recruiting → Recruiting
-
Apr 2023 — May 2023 [monthly]
Not Yet Recruiting PHASE3
First recorded
Eligibility Summary
No eligibility information available.
Contact Information
- Shanghai Miracogen Inc.
For direct contact, visit the study record on ClinicalTrials.gov .