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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
100
1.0/1.25/1.5 mg/kg, intravenous (IV) infusion every cycle until disease progression or intolerable toxicity, etc.
240mg intravenous (IV) infusion every cycle until disease progression or intolerable toxicity, etc.
Beijing Cancer Hospital
Beijing, Beijing Municipality, China
RECRUITINGincidence of AE/SAE
adverse event(AE) 、serious adverse event(SAE)
Time frame: Up to 24 months
Objective Response Rate, ORR
complete response (CR) or partial response (PR)
Time frame: Up to 24 months
Duration of Response, DOR
Time from the date of the first CR or PR to the earliest date of disease progression or death
Time frame: Up to 24 months
Time To Response, TTR
Time from the date of first infusion to the date of CR or PR
Time frame: Up to 24 months
Disease Control Rate, DCR
the percentage of subjects who experience CR, PR or stable disease (SD)
Time frame: Up to 24 months
Progression-Free Survival, PFS
Time from the date of first infusion to the earliest date of disease progression or death
Time frame: Up to 24 months
Overall Survival, OS
Time from the date of first infusion to the date of death
Time frame: Up to 24 months
Pharmacokinetics parameter
drug concentration of 9MW2821
Time frame: Up to 12 months
Immunogenicity parameter
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Anti-Drug Antibody (ADA) of 9MW2821
Time frame: Up to 12 months