drugset / Trial / NCT03529526

Study of the Safety, Tolerability, Pharmacokinetics, Immunogenicity and Antitumor Activity of KN046 in Subjects With Advanced Solid Tumors

NCT03529526

Phase 1 Unknown 21 enrolled Alphamab (Australia) Co Pty Ltd.
SequentialOpen-labelTreatment

Summary

This is an open-label, multicenter, dose-escalation phase I study to assess the safety, tolerability and preliminary efficacy of KN046 in participants with all advanced solid tumors who are not able to have current standard anti-tumor therapies. The purpose of this study is to determine the maximum tolerated dose (MTD) or a biological effective dose (BED), to characterise the safety, pharmacokinetics (PK), immunogenicity, pharmacodynamics (PD) and anti-tumor activity of KN046 as a single agent in adult participants with advanced solid tumors

Timeline

Start
2018-05-21
Primary completion
2019-10-30
Completion
2020-03-30

Drugs

EvaluationDrugModalityDoseRoute
Subject ERFONRILIMAB Monoclonal antibody 0.3 mg/kg
Subject ERFONRILIMAB Monoclonal antibody 1 mg/kg
Subject ERFONRILIMAB Monoclonal antibody 3 mg/kg
Subject ERFONRILIMAB Monoclonal antibody 5 mg/kg
Subject ERFONRILIMAB Monoclonal antibody 10 mg/kg

Indications