NCT04272944

A Study of MSB2311 in Advanced Solid Tumors

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 42 (actual)
• Sponsor: Suzhou Transcenta Therapeutics Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Advanced Solid Tumor

Interventions

Type	Name	Description
DRUG	10 mg/kg Q2W	10 mg/kg MSB2311 every two weeks
DRUG	20 mg/kg Q3W	20 mg/kg MSB2311 every three weeks.

Timeline

• Start date: 2018-08-13
• Primary completion: 2022-01-31
• Completion: 2022-01-31
• First posted: 2020-02-17
• Last updated: 2023-12-18

Locations

1 site across 1 country: China

Regulatory

• FDA-regulated drug study