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.

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