drugset / Trial / NCT07024394

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

NCT07024394

Phase 1/2 Not yet recruiting 65 enrolled Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd.
NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2025-06-12
Primary completion
2029-09-23
Completion
2029-09-23

Drugs

EvaluationDrugModalityDoseRoute
Subject Luvometinib Small molecule 5 mg/m2 Oral