drugset / Trial / NCT07024394
Follow-up Study to Evaluate the Safety and Efficacy of FCN-159 in Pediatric Participants With Neurofibromatosis Type 1
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Luvometinib | Small molecule | 5 mg/m2 | Oral |