Phase I Study of KN035 in Chinese Subjects With Advanced Solid Tumors

Phase 1 Completed 287 enrolled 3D Medicines (Sichuan) Co., Ltd.

NaSingle-groupOpen-labelTreatment

Summary

This dose escalation and dose expansion study is to evaluate and characterize the tolerability and safety profile of single agent KN035 in Chinese adult subjects with unresectable advanced carcinoma.

Timeline

Start: 2017-03-21
Primary completion: 2019-09-02
Completion: 2020-08-25

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.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Envafolimab	Monoclonal antibody	0.1 mg/kg	Subcutaneous
Subject	Envafolimab	Monoclonal antibody	0.3 mg/kg	Subcutaneous
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

Phase I Study of KN035 in Chinese Subjects With Advanced Solid Tumors

Summary

Timeline

Publications

Drugs

Indications