Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07526792 | SYS6002 vs Chemotherapy in Patients With Locally Advanced or Metastatic Urothelial Carcinoma | PHASE3 | NOT YET_RECRUITING | 406 | — | — | Jun 20, 2026 | Dec 1, 2029 | Apr 13, 2026 | - | — |
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.
| Arm | Type | Description |
|---|---|---|
| SYS6002 | EXPERIMENTAL | SYS6002 monotherapy |
| Chemotherapy | ACTIVE_COMPARATOR | Investigator's choice of one of chemotherapy treatment (docetaxel, paclitaxel or pemetrexed) |
| Name | Type | Description |
|---|---|---|
| SYS6002 | DRUG | SYS6002 by intravenous (IV) |
| Investigator's Choice of Chemotherapy | DRUG | 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) ). |
Inclusion Criteria: * 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 chemot...