This study is a Phase 1/2, first-in-human, open-label, dose-escalation and cohort expansion study designed to characterize the safety, tolerability, pharmacokinetics, pharmacodynamics, preliminary antitumor activity and immunogenicity of 8MW2311 administered by intravenous (IV) infusion.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
216
All subjects will receive a single intravenous (IV) infusion of 8MW2311 every 21 days (q21d), other dosing frequencies may be used.
The first affiliated hospital of bengbu medicial college
Bengbu, Anhui, China
Hunan cancer hospital
Changsha, Hunan, China
Jian Zhang
Shanghai, Shanghai Municipality, China
AEs
All the adverse events
Time frame: Up to 28 days post last dose
ORR
Objective Response Rate
Time frame: Up to 24 months
BOR
Best of Response
Time frame: Up to 24 months
DCR
Disease Control Rate
Time frame: Up to 24 months
CBR
Clinical Benefit Rate
Time frame: Up to 24 months
PFS
Progression-Free Survival
Time frame: Up to 24 months
DoR
Duration of Remission
Time frame: Up to 24 months
TTR
Time to Response
Time frame: Up to 24 months
TTP
Time to Progression
Time frame: Up to 24 months
OS
Overall Survival
Time frame: Up to 24 months
PK Parameter AUC
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The area under the curve (AUC)
Time frame: Up to 24 months
PK Parameter Cmax
Maximum concentration (Cmax)
Time frame: Up to 24 months
PK Parameter Tmax
Time at which maximum concentration(Tmax)
Time frame: Up to 24 months
PK Parameter T1/2
The half life(T1/2)
Time frame: Up to 24 months
Incidence of ADA
Incidence of Anti-Drug Antibody (ADA)
Time frame: Up to 24 months