To evaluate the safety, tolerability, and preliminary efficacy of 9MW2821 in combination with other anti-tumor agents in patients with advanced gynecological malignancies.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
260
Subjects will receive intravenous (IV) infusion of 9MW2821 +other anticancer therapy as per protocol
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China
ORR
Objective Response Rate
Time frame: Up to 24 months
DoR
Duration of Response
Time frame: Up to 24 months
TTR
Time to Response
Time frame: Up to 24 months
DCR
Disease Control Rate
Time frame: Up to 24 months
PFS
Progression Free Survival
Time frame: Up to 24 months
OS
Overall Survival
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: 24 months