Safety, Tolerability, Pharmacokinetics & Pharmacodynamics of an Anti-PD-1 mAb for Patients With Advanced Solid Tumors

Summary

The primary objective is to assess the safety and tolerability of JS-001 in subjects with various advanced or recurrent malignancies, including solid tumors and lymphomas, and to evaluate its preliminary efficacy. The secondary objectives are to: 1) characterize the single-dose and multi-dose pharmacokinetic (PK) profile of JS-001, 2) characterize the immunogenicity of JS-001; 3) assess the dose-efficacy relationship of JS-001 single agent, and 4) preliminarily evaluate biomarkers associated with the efficacy of JS-001. The exploratory objectives include to evaluate the consistency between biomarker detection results of archived tissue and fresh frozen tissue, and to assess the consistency of response using various response criteria (such as irRC, WHO, RECIST and irRECIST).

Timeline

Start

2016-08

Primary completion

2020-09

Completion

2020-12

Publications

• Yang J, Dong L, Yang S, Han X, Han Y, Jiang S, Yao J, Zhang Z, Zhang S, Liu P, Qin Y, Wu H, Feng H, Yao S, Sun Y, Song H, Shi Y. Safety and clinical efficacy of toripalimab, a PD-1 mAb, in patients with advanced or recurrent malignancies in a phase I study. Eur J Cancer. 2020 May;130:182-192. doi: 10.1016/j.ejca.2020.01.028. Epub 2020 Mar 27.

Drugs

Indications