This is a phase Ib/II, open-label, multicenter clinical study to evaluate the safety, tolerability, efficacy, pharmacokinetics and immunogenicity of 9MW2821 combined with Toripalimab injection in subjects with local advanced or metastatic urothelial cancer.
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Male or female subjects aged 18 to 80 years (including 18 and 80 years).
ECOG status of 0 or 1.
Histologically or cytologically confirmed local advanced or metastatic urothelial cancer
Anti-tumor treatment such as chemotherapy and radiotherapy within 21 days prior to the first dose of study drug.
Major surgery within 28 days prior to first dose of study drug.
PD-1/PD-L1/PD-L2 inhibitors used in the previous treatment for La/m UC.
Previous treatment with ADCs conjugated with MMAE payload.
Single group
9MW2821
Drug1.0/1.25/1.5 mg/kg, intravenous (IV) infusion every cycle until disease progression or intolerable toxicity, etc.
Toripalimab
Drug240mg intravenous (IV) infusion every cycle until disease progression or intolerable toxicity, etc.
incidence of AE/SAE
adverse event(AE) 、serious adverse event(SAE)
Objective Response Rate, ORR
complete response (CR) or partial response (PR)
Duration of Response, DOR
Time from the date of the first CR or PR to the earliest date of disease progression or death
Time To Response, TTR
Time from the date of first infusion to the date of CR or PR
Disease Control Rate, DCR
the percentage of subjects who experience CR, PR or stable disease (SD)
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