This is a phase I study to determine the safety and toxicity, PK/PD, immunogenicity, biomarkers, anti-tumor activity and establish a preliminary recommended Phase 2 dose (RP2D) in subjects with advanced solid tumors.
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, biomarkers, and anti-tumor activity of MSB2311.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
42
An intravenous infusion with concentration from 3 mg/kg (Q3W)
An intravenous infusion with concentration from 10 mg/kg (Q3W)
An intravenous infusion with concentration from 20 mg/kg (Q3W)
South Texas Accelerated Research Therapeutics
San Antonio, Texas, United States
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 or recommended phase 2 dose
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
Time frame: Up to 30 days following the last dose
Peak Plasma concentration (Cmax)for MSB2311
Incidence and quantity of anti-drug antibodies
Time frame: Up to 30 days following the last dose
Volume of plasma from which MSB2311 is completely removed per unit time (CL)
Time frame: Up to 30 days following the last dose
The incidence of subjects generating anti-drug antibody
Time frame: Up to 30 days following the last dose
Objective response rate (ORR) as measured by RESISTv1.1
Time frame: Up to 30 days following the last dose
Duration of response (DOR) as measured by RESISTv1.1
Time frame: Up to 30 days following the last dose
Progression-free survival (PFS) as measured by RESISTv1.1
Time frame: Up to 30 days following the last dose
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
An intravenous infusion with concentration from 10 mg/kg (Q2W)
Best overall response as measured by RESISTv1.1
Time frame: Up to 30 days following the last dose
Overall survival (OS) as measured by RESISTv1.1
Time frame: Up to 30 days following the last dose
Elimination half-life and apparent plasma terminal phase elimination rate constant (t1/2 ) of MSB2311
Time frame: Up to 30 days following the last dose