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

PHASE1/PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

160

Participants

Timeline

Start Date

March 26, 2021

Primary Completion Date

February 28, 2025

Study Completion Date

March 30, 2025

Conditions
Neurofibromatosis 1Plexiform NeurofibromaNF1
Interventions
DRUG

FCN-159

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

Trial Locations (14)

29425

Medical University of South Carolina - Hollings Cancer Center - PPDS, Charleston

32608

Principal Investigator Hans, Gainesville

33701

John Hopkins All Children Hospital, St. Petersburg

48202

Henry Ford Health System, Detroit

90027

Children's Hospital Los Angeles, Los Angeles

Unknown

Research Site, Beijing

Research Site, Guangzhou

Research Site, Hangzhou

Research Site, Shanghai

Research Site, Shijiazhuang

Research Site, Wuhan

Hospital Universitario Vall d'Hebron, Barcelona

Hospital Universitario 12 de Octubre, Madrid

Hospital Universitario La Paz, Madrid

All Listed Sponsors
lead

Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd.

INDUSTRY

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 | Biotech Hunter | Biotech Hunter