Abbisko Therapeutics Co., Ltd. is developing ABSK-021 to treat TGCT by targeting a protein that drives the growth of the tumor, known as the colony stimulating factor 1 (CSF1). ABSK-021 is an oral (50mg) daily medication that is designed to block CSF1. As an investigational drug, ABSK-021 has not been approved by the United States Food and Drug Administration (FDA) or any other regulatory agencies for sale or use by the public.
The purpose of this study is to test the safety and tolerability of an investigational drug, ABSK-021, as a potential new treatment for advanced solid tumors, including TGCT. This is a first-in-human study being done to learn more about the safety of the ABSK-021 and how well it works.
As of June 01, 2022, 32 TGCT patients have received ABSK-021. Majority of side effects have been mild-to-moderate. At 13 weeks, TGCT patients showed improvement in range of motion, pain, and stiffness. Due to the limited number of patients, there may be other side effects that are unknown, and the potential side effects listed below may change with the increase of patients enrolled to the study. It is currently recruiting at different global clinical locations.
For more information on the trial and the locations, visit the Phase I ABSK-021 trialor ask your healthcare provider.