NCT07024394

Follow-up Study to Evaluate the Safety and Efficacy of FCN-159 in Pediatric Participants With Neurofibromatosis Type 1

A Long-term Follow-up Study to Evaluate the Safety and Efficacy of Ruvometinib Tablets (FCN-159 Tablets) in Pediatric Participants With Neurofibromatosis Type 1

• Status: Not Yet Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 65 (estimated)
• Sponsor: Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd. · Industry
• Sex: All
• Age: 2 Years – 20 Years
• Healthy volunteers: Not accepted

Summary

FCN-159 (Luvometinib Tablets), an orally available and highly potent selective inhibitor of MEK1/2,demonstrated good tolerability and exhibited notable anti-tumor activity in pediatric pts with NF1-related PN in study NCT04954001.This study is a 5-year long-term follow-up of the FCN-159-002 study, involving all enrolled patients to further assess safety, growth and development effects, and treatment efficacy.

Conditions

• Neurofibromatosis 1
• Plexiform Neurofibroma
• NF1

Interventions

Type	Name	Description
DRUG	Luvometinib Tablets	5mg/m² (Maximum dose does not exceed 8mg, the recommended oral dose for adults), orally, once daily, until disease progression or study completion, whichever occurs first

Timeline

• Start date: 2025-06-12
• Primary completion: 2029-09-23
• Completion: 2029-09-23
• First posted: 2025-06-17
• Last updated: 2025-06-17

Locations

1 site across 1 country: China

Regulatory

• FDA-regulated drug study