NCT07526792
Not yet recruiting
Phase 3
A Randomized, Controlled, Open-Label, Multicenter Phase 3 Trial of SYS6002 Versus Investigator's Choice Chemotherapy in Patients With Locally Advanced or Metastatic Urothelial Carcinoma After Failure of Platinum-based Chemotherapy andPD-(L)1 Inhibitors
CSPC Megalith Biopharmaceutical Co.,Ltd.0 sites406 target enrollmentStarted: June 20, 2026Last updated:
ConditionsUrothelial Carcinoma
Overview
- Phase
- Phase 3
- Status
- Not yet recruiting
- Sponsor
- CSPC Megalith Biopharmaceutical Co.,Ltd.
- Enrollment
- 406
- Primary Endpoint
- Overall Survival
Overview
Brief 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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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 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);
- •5 Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
- •6 Life expectancy of ≥ 3 months;
- •7 Adequate major organ function (hematology, renal, liver, and coagulation) as determined by laboratory tests performed within 7 days prior to treatment;
- •8 Sexually active fertile participants must agree to use methods of contraception during the study and at least 6 months after termination of study therapy and have a negative urine or serum pregnancy test within 7 days prior to randomization;
- •9 Willing to participate in the study, understand the study procedures, and sign a written informed consent form.
Exclusion Criteria
- •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；
- •4\. Any serious and/or uncontrolled concurrent illness that may interfere with patient's participation in the study:
- •History of severe cardiovascular disease within 6 months prior to randomization, including but not limited to:
- •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);
- •With history of myocardial infarction, unstable angina pectoris, angioplasty and coronary artery bypass surgery;
- •New York Heart Association (NYHA) classification Grade III and above heart failure, and left ventricular ejection fraction (LVEF) \< 50% in the tests and examinations during the screening period;
- •Ischemic or Hemorrhagic Stroke;
- •Pulmonary Embolism Accident;
Arms & Interventions
Chemotherapy
Active Comparator
Investigator's choice of one of chemotherapy treatment (docetaxel, paclitaxel or pemetrexed)
Intervention: Investigator's Choice of Chemotherapy (Drug)
SYS6002
Experimental
SYS6002 monotherapy
Intervention: SYS6002 (Drug)
Outcomes
Primary Outcomes
Overall Survival
Time Frame: Up to approximately 3 years
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.
Secondary Outcomes
- Objective Response Rate (ORR)(Up to 3 years)
- Duration of Response (DOR)(Up to 3 years)
- Disease Control Rate (DCR)(Up to 3 years)
- Progression Free Survival (PFS)(Up to 3 years)
- Incidence of adverse events(Up to 3 years)
- Incidence of Anti-Drug Antibody (ADA)(Up to 3 years)
- Blood concentration of SYS6002(Up to 3 years)
Investigators
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