drugset / Trial / NCT05754853
A Study of MRG002 Versus Investigator's Choice of Chemotherapy in the Treatment of Patients With HER2-positive Unresectable Advanced or Metastatic Urothelial Cancer
RandomizedParallel-groupOpen-labelTreatment
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.
Timeline
- Start
- 2023-04-06
- Primary completion
- 2025-10
- Completion
- 2027-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Docetaxel | Small molecule | 75 mg/m2 | Intravenous |
| Subject | Gemcitabine | Small molecule | 1000 mg/m2 | Intravenous |
| Subject | Paclitaxel | Small molecule | 175 mg/m2 | Intravenous |
| Subject | Pemetrexed | Small molecule | 500 mg/m2 | Intravenous |
| Comparator | TRASTUZUMAB VEDOTIN | Unknown | 2.2 mg/kg | Intravenous |