drugset / Trial / NCT03676946

A Clinical Study of PD-L1 Antibody ZKAB001(Drug Code) in Locally Advanced and Metastatic Urothelial Carcinoma

NCT03676946

Phase 1/2 Unknown 15 enrolled Lee's Pharmaceutical Limited
Non-randomizedSequentialOpen-labelTreatment

Summary

This is a Phase 1+2, open-label, dose-escalation, and multidose study, aiming to investigate the safety, tolerability and pharmacokinetics of ZKAB001 (a fully human monoclonal antibody targeting the Programmed Death - Ligand 1 (PD-L1) membrane receptor on T lymphocytes and other cells of the immune system) administered every 14 days in subjects with locally advanced and metastatic urothelial carcinoma.

Timeline

Start
2018-10-10
Primary completion
2020-02-14
Completion
2023-06-23

Drugs

EvaluationDrugModalityDoseRoute
Subject Socazolimab Monoclonal antibody 5 mg/kg Intravenous
Subject Socazolimab Monoclonal antibody 10 mg/kg Intravenous
Subject Socazolimab Monoclonal antibody 15 mg/kg Intravenous

Indications