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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
406
SYS6002 by intravenous (IV)
Investigator's choice of chemotherapy means the chemotherapy chosen by investigators to treat urothelial carcinoma including docetaxel (75 mg/m\^2 by IV on Day 1, every 21 days),paclitaxel (175 mg/m\^2 by IV on Day 1, every 21 days)or pemetrexed (500 mg/m\^2 by IV on Day 1, every 21 days) ).
Overall Survival
Overall survival is defined as the time from the date of randomization to the date of death due to any cause. In the absence of confirmation of death, survival time will be censored at the last date the participant is known to be alive.
Time frame: Up to approximately 3 years
Objective Response Rate (ORR)
Objective response rate is defined as the percentage of participants with a confirmed complete response (CR) or partial response (PR) per RECIST v.1.1.
Time frame: Up to 3 years
Duration of Response (DOR)
DOR is defined as the time from the date of the first confirmed objective response (CR or PR that is subsequently confirmed) to the date of the first documented disease progression (PD) per RECIST v1.1 or death from any cause, whichever occurs first
Time frame: Up to 3 years
Disease Control Rate (DCR)
The percentage of participants who experience a best response of CR, PR or stable disease (SD).
Time frame: Up to 3 years
Progression Free Survival (PFS)
PFS is defined as the time from the date of randomization to the first documentation of PD as assessed by investigator per RECIST v.1.1, or death due to any cause, whichever occurs earlier.
Time frame: Up to 3 years
Incidence of adverse events
Time frame: Up to 3 years
Incidence of Anti-Drug Antibody (ADA)
Time frame: Up to 3 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Blood concentration of SYS6002
Time frame: Up to 3 years