This is a first-in-human (FIH), open-label, Phase 1 dose-Escalation Study of MSB2311, a humanized anti-PD-L1 monoclonal antibody, in subjects with advanced solid tumors. Qualified subjects will be enrolled to receive their assigned dose regimen of MSB2311 until disease progression or intolerable toxicity, withdrawal of consent, or end of study, whichever occurs first. The maximum treatment duration is 2 years. During the study, subjects will be evaluated for safety and toxicity, PK/PD, immunogenicity and anti-tumor activity of MSB2311.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
42
10 mg/kg MSB2311 every two weeks
20 mg/kg MSB2311 every three weeks.
Mabspace Biosciences (Suzhou) Co., Ltd.
Suzhou, Jiangsu, China
Safety and tolerability of MSB2311
Measured by number adverse events that are related to treatment
Time frame: Up to 90 days following the last dose
Maximum tolerated dose(MTD) or recommended phase2 dose(RP2D)
Measured by number of subjects experiencing DLT in each escalation cohort
Time frame: Up to 90 days following the last dose
Area under the plasma concentration versus time curve (AUC) for MSB2311
Changes in AUC over time in subjects with MSB2311
Time frame: Up to 30 days following the last dose
Peak Plasma concentration (Cmax)for MSB2311
Cmax is the maximum observed plasma concentration
Time frame: Up to 30 days following the last dose
Time to the Maximum Observed Plasma Concentration (Tmax)
Tmax is the time in hours/days to reach Cmax following dosing
Time frame: Up to 30 days following the last dose
Terminal elimination half-life (t1/2)
The time required for the plasma level of the study drug to decrease by one-half during the terminal elimination phase
Time frame: Up to 30 days following the last dose
Objective response rate (ORR) as measured by RESISTv1.1
Time frame: Up to 90 days following the last dose
Duration of response (DOR) as measured by RESISTv1.1
Time frame: Up to 90 days following the last dose
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Progression-free survival (PFS) as measured by RESISTv1.1
Time frame: Up to 90 days following the last dose
Best overall response as measured by RESISTv1.1
Time frame: Up to 90 days following the last dose
Overall survival (OS) as measured by RESISTv1.1
Time frame: Up to 90 days following the last dose