The primary purpose of this study is to demonstrate Pharmacokinetic similarity in exposure after the initial dose and at steady state of QL2107 compared with Keytruda.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
122
AUCtau,sd of QL2107 and Keytruda
Area under the concentration time curve for 1 dosing interval (tau = 21 days) after a single initial) dose (AUCtau,sd) of QL2107 and Keytruda® will be reported.
Time frame: At Cycle 1 (cycle length = 21 days)]
AUCtau,ss of QL2107 and Keytruda
Area under the concentration time curve for 1 dosing interval (tau = 21 days) at steady state (AUCtau,ss) of QL2107 and Keytruda® will be reported.
Time frame: At Cycle 7 (cycle length = 21 days)]
Cmax,sd of QL2107 and Keytruda
Maximum (peak) serum concentration after a single dose (Cmax,sd) of QL2107 and Keytruda® will be reported.
Time frame: At Cycle 1 (cycle length = 21 days)]
Cmax,ss of QL2107 and Keytruda
Maximum (peak) serum concentration at steady state (Cmax,ss) of QL2107 and Keytruda® will be reported.
Time frame: At Cycle 7 (cycle length = 21 days)]
Ctrough of QL2107 and Keytruda
The trough serum concentration measured before the next dose is administered (Ctrough) of QL2107 and Keytruda® (predose samples) will be reported.
Time frame: Up to Cycle 10 at Predose (cycle length = 21 days)
Number of Participants With Antidrug Antibodies (ADAs) and Neutralizing Antibodies (NAbs)
Time frame: Up to Week 52
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Time frame: Up to Week 52
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.