Clinical Trial

Study to Evaluate the Safety, Tolerability, PK Characteristics and Anti-tumor Activity of FCN-159 in Adult and Pediatric Participants With Neurofibromatosis Type 1

Active, Not Recruiting Phase 1/2
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Record status
This record was last updated November 12, 2024 (before its estimated February 28, 2025 completion). Its status may not reflect the trial's current state.
Summary
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.
Protocol Amendment History 6 amendments
This ClinicalTrials.gov record has been amended 6 times since 2021-06-28; most recent amendment 2024-11-08.
Status change: Recruiting → Active, Not Recruiting 2023-09-11
Status change: Not Yet Recruiting → Recruiting 2022-04-26
Trial Details
NCT Number NCT04954001
Lead Sponsor Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd.
Conditions Neurofibromatosis 1, Plexiform Neurofibroma, NF1
Enrollment 160 participants
Start Date 2021-03-26
Primary Completion 2025-02-28 (estimated)
Study Completion 2025-03-30 (estimated)
Updated on ClinicalTrials.gov 2024-11-12