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

PHASE1/PHASE2Not yet recruitingINTERVENTIONAL
Enrollment

65

Participants

Timeline

Start Date

June 12, 2025

Primary Completion Date

September 23, 2029

Study Completion Date

September 23, 2029

Conditions
Neurofibromatosis 1Plexiform NeurofibromaNF1
Interventions
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

Trial Locations (1)

200011

Shanghai Ninth People's Hospital, Shanghai

All Listed Sponsors
lead

Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd.

INDUSTRY

NCT07024394 - Follow-up Study to Evaluate the Safety and Efficacy of FCN-159 in Pediatric Participants With Neurofibromatosis Type 1 | Biotech Hunter | Biotech Hunter