9MW2821 in Combination With Toripalimab vs Standard Chemotherapy in Locally Advanced or Metastatic Urothelial Cancer

Inclusion Criteria:

• Sign the informed consent form approved by IEC.

• Male or female subjects aged 18 to 80 years.

• ECOG status: 0 or 1.

• Histologically confirmed local advanced or metastatic urothelial cancer

• Previously untreated with local advanced or metastatic urothelial cancer

• At least one measurable lesion, according to RECIST V1.1.

• Adequate tumor tissues submitted for test

• Suitable for cisplatin/carboplatin-based chemotherapy assessed by investigator

• Life expectancy for more than 12 weeks.

• Adequate organ functions.

• Proper contraception methods.

• Willingness to follow the study procedures.

Exclusion Criteria:

• History of another malignancy within 3 years.

• History of autoimmune disease requiring systemic treatment within 2 years.

• History of clinically significant cardiac/cerebrovascular diseases or thrombosiswithin 6 months.

• Major surgery treated within 28 days; Any live vaccines got within 28 days;Radiotherapy or Intravesical therapy treated within 21 days; Traditional Chinesemedicine or any potent CYP3A4 inducers/inhibitors taken within 14 days.

• Lots of pleural fluid and ascites, uncontrolled bone pain or spinal compressionexisted within 14 days; Systemic treatment with active infection within 7 days.

• Previously treated with PD-1, PD-L1, PD-L2, CTLA-4 inhibitors; Previously treatedwith ADCs which target Nectin-4 or are conjugated with payload MMAE; Organtransplantation or allogeneic hematopoietic stem cell transplantation in the past.

• Clinical significantly toxicity Grade ≥ 2 (except alopecia and pigmentation) relatedto previous treatment.

• Any situations adding the risk of severe dry eye, active keratitis or corneal ulcer,etc.

• Peripheral neuropathy Grade ≥ 2.

• Any other serious chronic or uncontrolled disease.

• Uncontrolled central nervous system metastases or carcinomatous meningitis.

• Active HBV/HCV/HIV infection, etc.

• Known allergic sensitivity to any of the ingredients of the study drug.

• History of drug abuse or mental illness.

• Other conditions unsuitable into the study.