NCT04954001

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

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

• Status: Active Not Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 160 (estimated)
• Sponsor: Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd. · Industry
• Sex: All
• Age: 2 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Neurofibromatosis 1
• Plexiform Neurofibroma
• NF1

Interventions

Type	Name	Description
DRUG	FCN-159	FCN-159 is administered orally in once daily schedule for 28 days a cycle.

Timeline

• Start date: 2021-03-26
• Primary completion: 2025-02-28
• Completion: 2025-03-30
• First posted: 2021-07-08
• Last updated: 2024-11-12

Locations

14 sites across 3 countries: United States, China, Spain

Regulatory

• FDA-regulated drug study