drugset
drugset / Trial / NCT04126590

Phase I Study of KN044 in Locally Advanced/Metastatic Solid Tumors

NCT04126590 ↗

Phase 1 Unknown 39 enrolled Changchun Intellicrown Pharmaceutical Co. LTD
Non-randomizedSequentialOpen-labelTreatment

Summary

This is an open-label, multicenter, dose-escalation phase I study to assess the safety, tolerability and preliminary efficacy of KN044 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) , to characterise the safety, pharmacokinetics (PK), immunogenicity, pharmacodynamics (PD) and anti-tumor activity of KN044 as a single agent in adult participants with advanced solid tumors.

Timeline

Start
2020-01-09
Primary completion
2024-06-01
Completion
2024-08-01

Drugs

EvaluationDrugModalityDoseRoute
Subject KN044 Protein / enzyme biologic 0.03 mg/kg Intravenous
Subject KN044 Protein / enzyme biologic 0.1 mg/kg Intravenous
Subject KN044 Protein / enzyme biologic 0.3 mg/kg Intravenous
Subject KN044 Protein / enzyme biologic 1 mg/kg Intravenous
Subject KN044 Protein / enzyme biologic 3 mg/kg Intravenous
Subject KN044 Protein / enzyme biologic 6 mg/kg Intravenous
Subject KN044 Protein / enzyme biologic 10 mg/kg Intravenous

Indications

cancer