drugset / Trial / NCT03529526
Study of the Safety, Tolerability, Pharmacokinetics, Immunogenicity and Antitumor Activity of KN046 in Subjects With Advanced Solid Tumors
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| 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 | — |