NCT03463473

A Phase I Study of MSB2311 in Advanced Solid Tumors

First-in-human, Open-label, Phase 1 Dose-Escalation Study of MSB2311, A Humanized Anti-PD-L1 Monoclonal Antibody in Subjects 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
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Advanced Solid Tumors

Interventions

Type	Name	Description
DRUG	3 mg/kg Q3W MSB2311 Injection	An intravenous infusion with concentration from 3 mg/kg (Q3W)
DRUG	10 mg/kg Q3W MSB2311 Injection	An intravenous infusion with concentration from 10 mg/kg (Q3W)
DRUG	20 mg/kg Q3W MSB2311 Injection	An intravenous infusion with concentration from 20 mg/kg (Q3W)
DRUG	10 mg/kg Q2W MSB2311 Injection	An intravenous infusion with concentration from 10 mg/kg (Q2W)

Timeline

• Start date: 2018-04-12
• Primary completion: 2020-06-01
• Completion: 2020-06-01
• First posted: 2018-03-13
• Last updated: 2023-12-18

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study