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).
1.Participantss aged 18-75 years (inclusive);
2. Pathologically confirmed patients with locally advanced or metastatic urothelial carcinoma
3 Participants havefailed of platinum-based chemotherapy and PD-(L)1 inhibitors; for participants who received platinum-based chemotherapy and PD-(L)1 inhibitors in the adjuvant/neoadjuvant setting, disease recurrence or progression must have occurred within 12 months after completion of that therapy; radiographically confirmed disease progression during or after the most recent treatment regimen;
4 Participants must have measurable disease according to RECIST (version 1.1);
1. Active central nervous system metastases or leptomeningeal metastasis;
2. Prior Nectin-4-targeted therapy;
3. Adverse events from prior antitumor therapy not recovered to Grade ≤ 1 per NCI-CTCAE v5.0；
Severe cardiac rhythm or conduction abnormalities, such as ventricular arrhythmia and third-degree atrioventricular block requiring clinical intervention; corrected QT interval > 480 ms by Fridericia method (Fridericia formula: QTcF = QT/RR^0.33, RR = 60/heart rate);
Parallel
SYS6002
DrugSYS6002 by intravenous (IV)
Investigator's Choice of Chemotherapy
DrugInvestigator'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.
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.
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
Disease Control Rate (DCR)
The percentage of participants who experience a best response of CR, PR or stable disease (SD).
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.
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