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

NCT07024394 · tracked via the Priya Life Science China tracker

Sponsor

Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd.

Phase

Phase 1/2

Started

2025-06-12

Last updated

2025-06-17

Condition(s) studied

Neurofibromatosis 1Plexiform NeurofibromaNF1

Investigational drug(s) / intervention(s)

Luvometinib Tablets

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

Study 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.

Eligibility

Sex

ALL

Min age

2 Years

Max age

20 Years

Healthy volunteers

Inclusion Criteria: Patients from the pediatric cohort of the FCN-159-002 study. Willing to participate in the long-term follow-up study and capable of understanding and voluntarily signing the informed consent form. Exclusion Criteria: Any clinically significant condition that, in the investigator's judgment, may interfere with study participation or compliance with safety requirements. Patients unable to comply with visit-related requirements.

Primary outcome measure(s)

long term safty — Through study completion, about 5 years
Adverse events during treatment of FCN-159 will be assessed by the investigators according to CTCAE 5.0.

Trial sites (1)

Facility	City	Region	Status
Shanghai Ninth People's Hospital	Shanghai	Shanghai Municipality

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Other trials for the same condition

Efficacy and Safety of Selumetinib in Adults With NF1 Who Have Symptomatic, Inoperable Plexiform Neurofibromas Active, not recruiting

HL-085 in Adults With Neurofibromatosis Type 1 (NF1) and Inoperable Plexiform Neurofibromas Recruiting

FCN-159 in Adult Patients With Symptomatic, Inoperable Neurofibromatosis Type 1-Related Plexiform Neurofibromas Active, not recruiting

Study to Evaluate the Safety, Tolerability, PK Characteristics and Anti-tumor Activity of FCN-159 in Adult and Pediatric Participants With Neurofibromatosis Type 1 Active, not recruiting

Evaluation of TQ-B3234 Capsules in Patients With Symptomatic, Non-Surgical Type 1 Neurofibromatosis-Associated Plexiform Neurofibromas Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07024394 on ClinicalTrials.gov ↗ ← All trials in China