Trial Number
657-26
Participant Age Range
180 Days to 22 Years
Participant Gender
Any
Enrolling Participants
Yes
Overview
“Phase 2 Study of Tovorafenib (DAY101) in Relapsed and Refractory Langerhans Cell Histiocytosis”
Researchers are studying an investigational targeted therapy called tovorafenib (DAY101) for children, adolescents, and young adults with relapsed or refractory Langerhans cell histiocytosis (LCH). LCH is a rare disease in which abnormal immune cells can damage tissues and organs. This Phase 2 study will evaluate how well tovorafenib works, how long responses last, and its safety in patients whose disease has returned or did not respond to previous treatment. Participants will take tovorafenib by mouth once weekly for up to 12 months and will undergo regular exams, blood tests, imaging scans, and follow-up visits.