Study of Vimseltinib for Tenosynovial Giant Cell Tumor
Status:
Recruiting
Trial end date:
2026-07-01
Target enrollment:
Participant gender:
Summary
This is a multicenter Phase 3 clinical study, which aims to evaluate the effectiveness of an
investigational drug called vimseltinib for the treatment of tenosynovial giant cell tumor
(TGCT) in cases where surgical removal of the tumor is not an option.
The study consists of two parts. In Part 1, eligible study participants will be assigned to
receive either vimseltinib or matching placebo for 24 weeks. A number of assessments will be
carried out during the course of the study, including physical examinations, blood tests,
imaging studies, electrocardiograms, and questionnaires. MRI scans will be used to evaluate
the response of the tumors to the treatment. Participants assigned to placebo in Part 1 will
have the option to receive vimseltinib for Part 2. Part 2 is a long-term treatment phase in
which all participants receive open-label vimseltinib.