NCT06913725

An Exploratory Study to Evaluate the Efficacy and Safety of FCN-159 in Patients With Brain Arteriovenous Malformations

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: Xuanwu Hospital, Beijing · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

A single-center, open-label, non-randomized controlled exploratory study is conducted in the Xuanwu Hospital Capital Medical University to evaluate the efficacy and safety of FCN-159 in patients with brain arteriovenous malformations (BAVM), aiming to overcome the current clinical challenges caused by the lack of available drugs for this disease.

Detailed description

This open-label Phase 2 study will evaluate the efficacy and safety of FCN-159 in participants with BAVM disease who currently deemed unsuitable for surgery, radiotherapy, interventional embolization, or lacking corresponding surgical treatment indications based on investigator judgment. Eligible patients have no prior rupture. This project plans to recruit 10 patients with BAVMs. They are 1：1 divided into FCN-159 group and no-treatment controlled group. It is stratified by gender, age (±5 years), anatomical site of the lesion, Spetzer-Martin grade. FCN-159 will be administered orally and treatment will be continuous, 28 days as a cycle. The major efficacy outcome measure is overall response rate (ORR) assessed by silence MRA. Participants will be evaluated radiologically at 3, 6, 12 treatment cycles after initiation of treatment, and then every 6 treatment cycles and EOT.

Conditions

• Brain Arteriovenous Malformations

Interventions

Type	Name	Description
DRUG	FCN-159	An investigational oral MEK inhibitor

Timeline

• Start date: 2025-02-24
• Primary completion: 2026-03-31
• Completion: 2026-09-30
• First posted: 2025-04-06
• Last updated: 2025-04-06

Locations

1 site across 1 country: China