drugset / Trial / NCT03248843
A Study of PD-L1 Antibody KN035 in Japanese Subjects With 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 Japanese patients with advanced and metastatic solid tumor. The dose escalation will follow the widely used 3+3 design.
Timeline
- Start
- 2017-09-15
- Primary completion
- 2020-03-31
- Completion
- 2020-03-31
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.
- Shimizu T, Nakajima TE, Yamamoto N, Yonemori K, Koyama T, Kondo S, Sunakawa Y, Izawa N, Horie Y, Xiang S, Xu S, Qin L, Gong J, Liu D. Phase I study of envafolimab (KN035), a novel subcutaneous single-domain anti-PD-L1 monoclonal antibody, in Japanese patients with advanced solid tumors. Invest New Drugs. 2022 Oct;40(5):1021-1031. doi: 10.1007/s10637-022-01287-7. Epub 2022 Aug 6.
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 |
Indications
No indication recorded.