This study is a Phase 2, open-label,multicenter study designed to evaluate the efficacy and safety of 9MW2821monotherapy or combined with PD-1 inhibitor in locally advanced or metastatic Triple-Negative Breast Cancer.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
160
Subjects will receive intravenous (IV) infusion of 9MW2821 as per protocol
Subjects will receive intravenous (IV) infusion of PD-1 inhibitor as per protocol
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
RECRUITINGObjective Response Rate
ORR
Time frame: Up to 24 months
Duration of Response
DoR
Time frame: Up to 24 months
Time to Response
TTR
Time frame: Up to 24 months
Disease Control Rate
DCR
Time frame: Up to 24 months
Progression Free Survival
PFS
Time frame: Up to 24 months
Overall Survival
OS
Time frame: Up to 24 months
Pharmacokinetic parameter:total antibody (TAb), antibody drug conjugate (ADC), and Monomethyl Auristatin E (MMAE)
Maximum observed concentration (Cmax)
Time frame: 24 months
Pharmacokinetic parameter:total antibody (TAb), antibody drug conjugate (ADC), and Monomethyl Auristatin E (MMAE)
Area under the concentration-time curve (AUC)
Time frame: 24 months
Pharmacokinetic parameter:total antibody (TAb), antibody drug conjugate (ADC), and Monomethyl Auristatin E (MMAE)
Half-life (t1/2)
Time frame: 24 months
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Pharmacokinetic parameter:total antibody (TAb), antibody drug conjugate (ADC), and Monomethyl Auristatin E (MMAE)
Clearance (CL)
Time frame: 24 months
Incidence of Anti-Drug Antibody (ADA)
ADA
Time frame: Up to 24 months