MANEUVER Study
(ABSK021-301)
MANEUVER Study (ABSK021-301), is a clinical study of ABSK021 in Patients with Tenosynovial Giant Cell Tumor to determine whether the study drug is safe and how well the antitumor activity of study drug.
ABSK021-301
ABSK021 is a highly selective and potent oral small-molecule CSF-1R inhibitor. The mechanism of action of ABSK021 is to inhibit CSF-1R and block the recruitment of inflammatory cells by tumor cells. Therefore, it is possible to exert antitumor activity in TGCT through this mechanism.
01
This study is randomized, double-blind, placebo-controlled and the eligible participants will be randomized (by chance) to ABSK021 treatment group or placebo group. A placebo is a pill which looks like ABSK021 but with no active ingredients.
02
About 90 participants will take part in this phase 3 study at about 46 investigational sites worldwide. In the US, there are approximately 20 participants from 10 investigational sites will take part in this study.
03
It’s voluntary to participate this study or not. If you would like to participate and are qualified, you will receive the treatment of ABSK021 or placebo at least 24 weeks firstly, and then will receive the treatment of ABSK021 at least 24 weeks.
You can find more study
information in ClinicalTrials.gov.
https://classic.clinicaltrials.gov/ct2/show/NCT05804045
