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.
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%.
Other concurrent malignancy within 3 years prior to randomization
Active autoimmune disease requiring systemic treatment within 2 years prior to randomization. Having received high dose corticosteroid (>10mg/day prednisolone equivalent) or other immunosuppressive agents.
Severe cardiovascular or cerebral vascular thrombo-embolic events within 6 months prior to randomization
Major surgery within 28 days prior to randomization, except for minor procedures that the PI considers not to impact study participation. Live vaccine within 28 days prior to randomization or planning to take live vaccine during the study. Radiotherapy or bladder infusion therapy within 21 days prior to randomization. Use of strong CYP3A4 inhibitors within 14 days prior to randomization.
Factorial
9MW2821
Druga nectin-4 ADC with MMAE payload
Toripalimab (JS001 )
Druganit-PD-1 antibody
Objective Response Rate
Objective Response Rate based on BICR
Other efficacy endpoints
Overall survival; progression-free survival, duration of response, disease control rate, objective response rate based on investigator assessment and BICR
Safety assessment
Incidences, severity and rates of treatment-emergent adverse events and treatment-related adverse events as assessed by CTCAE v5.0. Incidence and rates serious adverse events. Frequency of clinically significant abnormalities in physical examination, safety laboratory tests, urinalysis, vital signs, and 12-Lead ECG record.
Immunogenicity
Incidence, rates of ADA and NAb development. Titer of ADA and NAb.
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