A Study of GFH018 in Patients With Advanced Solid Tumors

Phase 1 Completed 50 enrolled Zhejiang Genfleet Therapeutics Co., Ltd.

Non-randomizedSingle-groupOpen-labelTreatment

Summary

This is the first- in human study of GFH018 comprised of a dose escalation part and a dose expansion part in subjects with advanced solid tumors after single/multiple administration. The study is designed to explore the safety/tolerability, pharmacokinetics, and MTD of GFH018 and to define a RP2D of GFH018.

Timeline

Start: 2019-08-30
Primary completion: 2022-08-11
Completion: 2022-08-11

Publications

Guo Y, Wang Z, Zhou H, Pan H, Han W, Deng Y, Li Q, Xue J, Ge X, Wang S, Wang J, Zhang Y, Zhao C, Zhu H, Wang Y, Shen H, Liu D, Li J. First-in-human study of GFH018, a small molecule inhibitor of transforming growth factor-beta receptor I inhibitor, in patients with advanced solid tumors. BMC Cancer. 2024 Apr 10;24(1):444. doi: 10.1186/s12885-024-12216-7.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	GFH018	Small molecule	5 mg	Oral
Subject	GFH018	Small molecule	10 mg	Oral
Subject	GFH018	Small molecule	20 mg	Oral
Subject	GFH018	Small molecule	30 mg	Oral
Subject	GFH018	Small molecule	40 mg	Oral
Subject	GFH018	Small molecule	50 mg	Oral
Subject	GFH018	Small molecule	65 mg	Oral
Subject	GFH018	Small molecule	85 mg	Oral

A Study of GFH018 in Patients With Advanced Solid Tumors

Summary

Timeline

Publications

Drugs

Indications