SYS6002 vs Chemotherapy in Patients With Locally Advanced or Metastatic Urothelial Carcinoma

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:
• •1. History of severe cardiovascular disease within 6 months prior to randomization, including but not limited to:
• •1. 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);
• •2. With history of myocardial infarction, unstable angina pectoris, angioplasty and coronary artery bypass surgery;
• •3. 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;
• •4. Ischemic or Hemorrhagic Stroke;
• •5. Pulmonary Embolism Accident;
• •2. Other clinically significant diseases:
• •1. HbA1c \> 8%;
• •2. Participants with active keratitis and corneal ulcer, or fundus lesions with a risk of blindness;
• •3. Grade ≥2 neuropathy prior to randomization;
• •4. Severe infection within 4 weeks prior to randomization; Active infection of Grade ≥2 (CTCAE v5.0) requiring systemic antibiotics, antivirals, or antifungals within 2 weeks prior to randomization;
• •5. Active HBV or HCV infection;
• •6. History of immunodeficiency (HIV-positive, acquired or congenital immunodeficiency, etc.), or organ transplantation;
• •7. History of another malignancy within 3 years prior to randomization;
• •8. History of interstitial lung disease (ILD) / non-infectious pneumonia, or current ILD/non-infectious pneumonia, or imaging findings at screening that cannot rule out these condition, except for those who are determined to be risk-free after discussion between the investigator and the sponsor;
• •9. Pleural effusion, ascites or pericardial effusion with syptoms or requiring puncture or drainage within 2 weeks prior to randomization;
• •5\. Use of other unmarketed clinical investigational drugs or treatments, chemotherapy, radiotherapy, or targeted therapy within 4 weeks prior to randomization; use of traditional Chinese medicine with anticancer indication, oral fluoropyrimidine drugs, small molecule targeted drug within 2 weeks prior to randomization; use of palliative radiation or local therapy within 2 weeks prior to randomization; or major surgery within 4 weeks prior to randomization;
• •6\. Allergy to any component of SYS6002 or to humanized monoclonal antibodies;
• •7\. Other conditions deemed by the investigator as unsuitable for participation in this clinical trial.