This study is a Phase 1, first-in-human, open-label, dose-escalation and cohort expansion study designed to characterize the safety, tolerability, pharmacokinetics, preliminary antitumor activity and immunogenicity of 9MW2821 administered by intravenous (IV) infusion.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
40
All subjects will receive a single intravenous (IV) infusion of 9MW2821 once weekly for the first 3 weeks of every 4 week cycle (i.e., on Days 1, 8 and 15).
Beijing Cancer Hospital
Beijing, Beijing Municipality, China
RECRUITINGBeijing University Cancer Hospital
Beijing, Beijing Municipality, China
RECRUITINGIncidence of adverse events
Time frame: Up to 28 days post last drug administration
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
Pharmacokinetic parameter:total antibody (TAb), antibody drug conjugate (ADC), and Monomethyl Auristatin E (MMAE)
Clearance (CL)
Time frame: 24 months
Objective Response Rate
ORR
Time frame: Up to 24 months
Disease Control Rate
DCR
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
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Progression Free Survival
PFS
Time frame: Up to 24 months
Overall Survival
OS
Time frame: Up to 24 months
Incidence of Anti-Drug Antibody (ADA)
ADA
Time frame: Up to 24 months