A Study of GFH925 in Patients With Advanced Solid Tumors With KRAS G12C Mutations

Phase 1/2 Completed 334 enrolled Innovent Biologics (Suzhou) Co. Ltd.

NaSingle-groupOpen-labelTreatment

Summary

Phase Ia: To evaluate the safety/tolerability of GFH925 in subjects with KRAS G12C-mutated advanced solid tumors; To estimate the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) of GFH925. Phase Ib: To evaluate the efficacy of GFH925 in subjects with KRAS G12C mutant advanced colorectal cancer or other tumors. Phase II: To evaluate the efficacy of GFH925 in subjects with KRAS G12C mutant advanced non-small cell lung cancer (NSCLC).

Timeline

Start: 2021-09-13
Primary completion: 2023-02-20
Completion: 2024-12-20

Publications

Zhou Q, Meng X, Sun L, Huang D, Yang N, Yu Y, Zhao M, Zhuang W, Guo R, Hu Y, Pan Y, Shan J, Sun M, Yuan Y, Fan Y, Huang J, Liu L, Chu Q, Wang X, Xu C, Lin J, Huang J, Huang M, Sun J, Zhang S, Zhou H, Wu YL. Efficacy and Safety of KRASG12C Inhibitor IBI351 Monotherapy in Patients With Advanced NSCLC: Results From a Phase 2 Pivotal Study. J Thorac Oncol. 2024 Dec;19(12):1630-1639. doi: 10.1016/j.jtho.2024.08.005. Epub 2024 Aug 9.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	IBI351	Small molecule	600 mg	Oral

Indications

No indication recorded.