Phase 1/2a Study of JAB-21822 Plus JAB-3312 in Patients With Advanced Solid Tumors Harboring KRAS p.G12C Mutation

Summary

This is a multicenter, open-label phase 1/2a study consisting of two parts: dose escalation phase and dose expansion phase. The objective of the dose escalation phase is to evaluate the safety, tolerability and pharmacokinetics of JAB-21822 in combination with JAB-3312 in patients with advanced solid tumors harboring KRAS p.G12C mutation and to determine the RP2D for the combination therapy. In the dose expansion phase, preliminary efficacy and safety of the combination therapy at the RP2D will be further explored in patients with specific cancer harboring KRAS p.G12C mutation.

Timeline

Start

2022-04-14

Primary completion

2026-03

Completion

2026-03

Publications

• Zhong J, Zhao J, Duan J, Fang J, Fei K, Li X, Chen J, Wang Z, Chu Q, Yu Y, Liu Z, Zhang L, Zhao Y, Li X, Wu L, Xing L, Zhuang W, Fang X, Chang J, Pan Y, Dong X, Liu L, Bai C, Pan P, Song Q, Jin B, Cao B, Ye F, Shi J, Tang K, Wang-Gillam A, Ding Y, Bi C, Shao Y, Pang J, Wan R, Sun B, Xu J, Wang J; JAB-21822-1006 Study Group. Glecirasib plus sitneprotafib in patients with KRASG12C-mutated non-small-cell lung cancer in China: an open-label, multicentre, single-arm, phase 1/2a trial. Lancet Respir Med. 2026 Feb;14(2):163-173. doi: 10.1016/S2213-2600(25)00258-9. Epub 2025 Nov 29.
• Kang D, Wang Y, Lin Y, Ma WW, Morgensztern D, Leventakos K, Bi C, Ding Y, Xiong J, Yan M, Sun X, Wang P, Ma C, Wang Y. JAB-3312, a Potent Allosteric SHP2 Inhibitor That Enhances the Efficacy of RTK/RAS/MAPK and PD-1 Blockade Therapies. Clin Cancer Res. 2025 Jul 15;31(14):3019-3032. doi: 10.1158/1078-0432.CCR-24-3691.

Drugs

Indications