A Study of QL1706 in Subjects With Advanced Malignant Tumor

Summary

This is an open-label, multicenter, Phase 1, ascending dose escalation study of QL1706 in subjects with advanced malignant tumor. The study will be conducted in 2 parts. Part 1 of the study will be a dose escalation evaluation to determine the maximum tolerated dose (MTD) and to establish a recommended Phase 2 dose (RP2D) of QL1706. This study purpose is to describe the safety and tolerability, to assess Pharmacokinetics (PK) and immunogenicity, and to preliminarily assess the anti-tumor activity of QL1706 in subjects with advanced malignant tumor. Part 2 of the study will further characterize the PK parameters for QL1706 in subjects with advanced malignant tumor.

Timeline

Start

2020-03-31

Primary completion

2021-12-31

Completion

2023-12

Publications

• Ma Y, Lin S, Chen Q, Xue J, Yang Y, Zang A, Cheng Y, Zhang Y, Wang X, Chen Z, Qu S, He J, Chen C, Jin C, Zhu D, Li Q, Liu X, Su W, Ba Y, Li W, Li Q, Zhu C, Huang Z, Kang X, Xue S, Li H, Wang C, Luo F, Huang Y, Zhang L, Zhao H. Updated efficacy and predictive biomarkers of QL1706, a bifunctional PD-1/CTLA-4 dual blocker in advanced solid tumors-A phase 1/1b study. Cell Rep Med. 2025 Oct 21;6(10):102396. doi: 10.1016/j.xcrm.2025.102396. Epub 2025 Oct 3.
• Zhao Y, Ma Y, Zang A, Cheng Y, Zhang Y, Wang X, Chen Z, Qu S, He J, Chen C, Jin C, Zhu D, Li Q, Liu X, Su W, Ba Y, Hao Y, Chen J, Zhang G, Qu S, Li Y, Feng W, Yang M, Liu B, Ouyang W, Liang J, Yu Z, Kang X, Xue S, Yang G, Yan W, Yang Y, Liu Z, Peng Y, Fanslow B, Huang X, Zhang L, Zhao H. First-in-human phase I/Ib study of QL1706 (PSB205), a bifunctional PD1/CTLA4 dual blocker, in patients with advanced solid tumors. J Hematol Oncol. 2023 May 8;16(1):50. doi: 10.1186/s13045-023-01445-1.

Drugs

Indications