NCT06553365

Phase II Study of FCN-159 in NF2 Nerve Sheath Tumors

An Open, Single-Arm Phase II Study Evaluating the Efficacy and Safety of FCN-159 in Selected NF2-associated Nerve Sheath Tumors

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Academic / Other
• Sex: All
• Age: 16 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to evaluate the efficacy and safety of FCN-159 in patients with specific NF2-associated nerve sheath tumors.

Detailed description

1. A phase 2 single arm single center study, total 30 patients will be enrolled; 2. To evaluate the safety and efficacy of FCN-159, a Mek inhibitor, to treat NF2; associated nerve sheath tumors, age≥16, including benign and malignant tumors; 3. Primary endpoint: Objective response rate (ORR)；Secondary Outcome Measures： Clinical benefit rate (CBR)；24w WRS, OS et al..

Conditions

• Nerve Sheath Tumor

Interventions

Type	Name	Description
DRUG	FCN-159	FCN-159 8mg qd po

Timeline

• Start date: 2024-08-15
• Primary completion: 2026-07-31
• Completion: 2026-07-31
• First posted: 2024-08-14
• Last updated: 2025-07-29

Locations

1 site across 1 country: China