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.
The study is planning to enroll approximately 460 participants with unresectable locally advanced or metastatic urothelial cancer who have not previously received systematic treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
460
9MW2821, 1.25mg/kg, intravenous (IV) infusion
Toripalimab, 240mg, intravenous (IV) infusion
Gemcitabine: 1000mg/m2, intravenous (IV) infusion
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
RECRUITINGBICR-PFS
Progression-free survival, assessed by BICR
Time frame: up to 50 months
OS
Overall Survival
Time frame: up to 50 months
ORR
Objective response rate, assessed by BICR or investigator
Time frame: Up to 50 months
DCR
Disease control rate, assessed by BICR or investigator
Time frame: Up to 50 months
DoR
Duration of response, assessed by BICR or investigator
Time frame: Up to 50 months
PFS
Progression-free survival, assessed by investigator
Time frame: Up to 50 months
AE/SAE
Adverse event, serious adverse event
Time frame: Up to 50 months
Immunogenicity
Anti-Drug Antibody (ADA) of 9MW2821
Time frame: Up to 50 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Cisplatin: 70mg/m2 or Carboplatin: AUC=4.5/5, intravenous (IV) infusion.