Mabspace Biosciences (Suzhou) Co., Ltd.
Suzhou, Jiangsu, 215123, China
NCT Number: NCT04272944
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.
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Notify Me18 year–75 year
All sexes
Interventional
Phase 1
Suzhou, Jiangsu, 215123, China
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
10 mg/kg MSB2311 every two weeks
Other names: MSB2311 10 Q2W
20 mg/kg MSB2311 every three weeks.
Other names: MSB2311 20 Q3W
Time frame: Up to 90 days following the last dose
Measured by number adverse events that are related to treatment
Time frame: Up to 90 days following the last dose
Measured by number of subjects experiencing DLT in each escalation cohort
Time frame: Up to 30 days following the last dose
Changes in AUC over time in subjects with MSB2311
Time frame: Up to 30 days following the last dose
Cmax is the maximum observed plasma concentration
Time frame: Up to 30 days following the last dose
Tmax is the time in hours/days to reach Cmax following dosing
Time frame: Up to 30 days following the last dose
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 90 days following the last dose
Time frame: Up to 90 days following the last dose
Time frame: Up to 90 days following the last dose
Time frame: Up to 90 days following the last dose
Time frame: Up to 90 days following the last dose
Suzhou Transcenta Therapeutics Co., Ltd.
Industry
Phase I Clinical Trial on the Tolerability and Pharmacokinetics of Recombinant Humanized Anti-PD-L1 Monoclonal Antibody MSB2311 Injection in the Treatment of Patients With Advanced Solid Tumors
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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