drugset / Trial / NCT07526792
SYS6002 vs Chemotherapy in Patients With Locally Advanced or Metastatic Urothelial Carcinoma
RandomizedParallel-groupOpen-labelTreatment
Summary
This study is a randomized, controlled, open-label, multicenter phase III clinical trial, which aims to evaluate the efficacy,safety PK characteristics, and immunogenicity of SYS6002 compared with chemotherapy in participants with locally advanced or metastatic urothelial carcinoma. This study has not yet been submitted for ethical review. The current registration is a pre-registration. Recruitment will commence only after formal approval is obtained from the relevant Ethics Committee).
Timeline
- Start
- 2026-06-20
- Primary completion
- 2029-06-01
- Completion
- 2029-12-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Docetaxel | Small molecule | 75 mg/m2 | Intravenous |
| Subject | Paclitaxel | Small molecule | 175 mg/m2 | Intravenous |
| Subject | Pemetrexed | Small molecule | 500 mg/m2 | Intravenous |
| Subject | SYS6002 | Other / unclassified | — | Intravenous |