About this trial
This is a randomized, controlled, open-label, multicenter phase 3 clinical study to evaluate the efficacy, safety and immunogenicity of 9MW2821 combined with Toripalimab versus standard chemotherapy in first-line locally advanced or metastatic urothelial cancer.
Eligibility criteria
Qualifiers
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
Disqualifiers
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 thrombosis within 6 months.
Major surgery treated within 28 days; Any live vaccines got within 28 days; Radiotherapy or Intravesical therapy treated within 21 days; Traditional Chinese medicine or any potent CYP3A4 inducers/inhibitors taken within 14 days.
Trial design
Treatments tested in this trial
- 9MW2821
- Toripalimab
- Gemcitabine
- Cisplatin/Carboplatin