drugset / Trial / NCT03838848
KN046 in Patients With Advanced Non-small Cell Lung Cancer
Non-randomizedSequentialOpen-labelTreatment
Summary
This is a phase II, open label, multicenter study in subjects with advanced non-small cell lung cancer.
Timeline
- Start
- 2019-05-05
- Primary completion
- 2022-07-30
- Completion
- 2022-07-30
Publications
- Xiong A, Li W, Li X, Fan Y, Ma Z, Fang J, Xie Q, Zhuang W, Kang M, Wang J, Xu T, Xu M, Zhi L, Liu Q, Wang N, Zhou C. Efficacy and safety of KN046, a novel bispecific antibody against PD-L1 and CTLA-4, in patients with non-small cell lung cancer who failed platinum-based chemotherapy: a phase II study. Eur J Cancer. 2023 Sep;190:112936. doi: 10.1016/j.ejca.2023.05.024. Epub 2023 Jun 5.
- Song X, Xiong A, Wu F, Li X, Wang J, Jiang T, Chen P, Zhang X, Zhao Z, Liu H, Cheng L, Zhao C, Wang Z, Pan C, Cui X, Xu T, Luo H, Zhou C. Spatial multi-omics revealed the impact of tumor ecosystem heterogeneity on immunotherapy efficacy in patients with advanced non-small cell lung cancer treated with bispecific antibody. J Immunother Cancer. 2023 Feb;11(2):e006234. doi: 10.1136/jitc-2022-006234.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | ERFONRILIMAB | Monoclonal antibody | 3 mg/kg | Intravenous |
| Subject | ERFONRILIMAB | Monoclonal antibody | 5 mg/kg | Intravenous |
| Background | 500 mg/m2, Q3W, intravenous injection (IV) | Unknown | 500 mg/m2 | Intravenous |
| Background | AUC 5 IV Q3W; total dose calculated according to the Calvert formula, with the highest dose not exceeding 750 mg; 4 cycles. | Unknown | — | Intravenous |
| Background | Oral, QD | Unknown | — | Oral |