Sponsor: Shanghai Fosun Pharmaceutical Development Co., Ltd.
Sponsor Study ID: FCN-159-002
Study Title: A Multi center, Open label, Single arm Phase I Dose escalation and Phase II Dose expansion Study to Evaluate the Safety, Tolerability, PK Characteristics and Anti tumor Activity of FCN 159 in Adult and Pediatric Participants With Neurofibromatosis Type 1
CTO #: 103469
NCT Number: NCT04954001
Phase: I/II
Protocol Type: Treatment
Age Group: Both
Disease Sites: Brain and Nervous System
Study Objectives: FCN-159 is a highly active MEK1/2 inhibitor that was designed, synthesized and screened on the basis of the structure of trametinib. FCN-159 is an orally available and highly potent selective inhibitor of MEK1/2, which is expected to be a targeted therapy for the treatment of advanced solid tumors and neurofibromatosis type 1.