9MW2821 + Toripalimab vs 9MW2821 for 1st Line Locally Advanced or Metastatic Urothelial Carcinoma
Trial Parameters
Brief Summary
This study will compare the efficacy of 9MW2821+toripalimab versus 9MW2821 monotherapy in locally advanced or metastatic urothelial carcinoma patients who have not received any systemic treatment in the metastatic or advanced setting.
Eligibility Criteria
Inclusion Criteria: * Voluntary participation * Age 18-80 * ECOG 0-1 * Histologically confirmed inoperable locally advanced or metastatic urothelial carcinoma (including bladder, renal pelvis and ureter). Mixed histology with squamous or adenomatous differentiation is allowed if urothelial carcinoma differentiation is \>50%. * Has not received any systemic treatment for locally advanced or metastatic urothelial carcinoma * At least 1 measurable target lesion that satisfies RECIST v1.1 definition. If the patient has received radiotherapy, the target lesion needs to be outside the radiation field or has demonstrated clear progression after radiotherapy. * Life expectancy over 12 weeks * Appropriate hematological and organ functions * Agree to contraceptive measures until 180 days after the last dose of study drug administration * Able to understand and follow study visits, treatment, laboratory assessment and other procedures Exclusion Criteria: * Other concurrent malignancy within 3 yea