drugset / Trial / NCT02827968
Phase 1 Study of Anti-PD-L1 Monoclonal Antibody KN035 to Treat Locally Advanced or Metastatic Solid Tumors
NaSingle-groupOpen-labelTreatment
Summary
This is an open label, dose escalation study to evaluate the safety and tolerability of KN035 in advanced and metastatic solid tumor.
Timeline
- Start
- 2017-01-13
- Primary completion
- 2020-08
- Completion
- 2020-12
Publications
- Cui C, Wang J, Wang C, Xu T, Qin L, Xiao S, Gong J, Song L, Liu D. Model-informed drug development of envafolimab, a subcutaneously injectable PD-L1 antibody, in patients with advanced solid tumors. Oncologist. 2024 Sep 6;29(9):e1189-e1200. doi: 10.1093/oncolo/oyae102.
- Papadopoulos KP, Harb W, Peer CJ, Hua Q, Xu S, Lu H, Lu N, He Y, Xu T, Dong R, Gong J, Liu D. First-in-Human Phase I Study of Envafolimab, a Novel Subcutaneous Single-Domain Anti-PD-L1 Antibody, in Patients with Advanced Solid Tumors. Oncologist. 2021 Sep;26(9):e1514-e1525. doi: 10.1002/onco.13817. Epub 2021 May 27.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Envafolimab | Monoclonal antibody | 1 mg/kg | Subcutaneous |
| Subject | Envafolimab | Monoclonal antibody | 2.5 mg/kg | Subcutaneous |
| Subject | Envafolimab | Monoclonal antibody | 5 mg/kg | Subcutaneous |
| Subject | Envafolimab | Monoclonal antibody | 10 mg/kg | Subcutaneous |