Safety and Efficacy of DAY101 in Patients With Relapsed/Refractory LCH
Status:
Not yet recruiting
Trial end date:
2025-05-29
Target enrollment:
Participant gender:
Summary
This trial is an open-label, multi-center Phase 2 study to evaluate the safety and efficacy
of the pan-RAF inhibitor DAY101 in patients with relapsed/refractory LCH with pathologic
somatic mutations in genes encoding tyrosine kinase receptors, RAS or RAF. DAY101 will be
given orally at the recommended phase 2 dose (RP2D). The primary end point will be the
overall response rate. Disease-free, progression-free, and overall survival will be assessed
as secondary end points. Tumor biopsies and serial blood specimens will be collected for
correlative biology.