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FCN-159

DRUG5 trials

Sponsors

Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd., Cancer Institute and Hospital, Chinese Academy of Medical Sciences, Xuanwu Hospital, Beijing

Conditions

Brain Arteriovenous MalformationsLCHLangerhans Cell HistiocytosisMelanomaNF1Nerve Sheath TumorNeurofibromatosis 1Plexiform Neurofibroma

Phase 1

MEK Inhibitor FCN-159 To Treat Advanced Melanoma With NRAS-aberrant (Ia) and NRAS-mutant (Ib)or NF1-mutant(1b)
SuspendedNCT03932253
Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd.Melanoma
Start: 2019-03-21End: 2024-04-30Updated: 2024-03-27
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 recruitingNCT04954001
Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd.Neurofibromatosis 1, NF1, Plexiform Neurofibroma
Start: 2021-03-26End: 2025-03-30Target: 160Updated: 2024-11-12

Phase 2

To Evaluate the Efficacy, Safety, and PK Characteristics of FCN-159 in Pediatric Patients With Refractory/Recurrent LCH
RecruitingNCT05997602
Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd.Langerhans Cell Histiocytosis, LCH
Start: 2023-09-28End: 2027-05-14Target: 56Updated: 2025-01-24
Phase II Study of FCN-159 in NF2 Nerve Sheath Tumors
RecruitingNCT06553365
Cancer Institute and Hospital, Chinese Academy of Medical SciencesNerve Sheath Tumor
Start: 2024-08-15End: 2026-07-31Target: 30Updated: 2025-07-29
An Exploratory Study to Evaluate the Efficacy and Safety of FCN-159 in Patients With Brain Arteriovenous Malformations
RecruitingNCT06913725
Xuanwu Hospital, BeijingBrain Arteriovenous Malformations
Start: 2025-02-24End: 2026-09-30Target: 10Updated: 2025-04-06

Related Papers

Luvometinib in recurrent/refractory pediatric Langerhans cell histiocytosis: a single-arm, multi-center, phase 2 trial
Blood Cancer Journal2026-07-29
Phase 1 Study of Luvometinib Use in Pediatric Patients with Neurofibromatosis Type 1-Related Unresectable Plexiform Neurofibromas.
2025-10-26
Updated data of efficacy and safety of luvometinib (FCN-159) in pediatric participants with neurofibromatosis type 1 from a multi-center, open-label, single-arm phase 2 study.
Journal of Clinical Oncology2025-05-281 citations
Efficacy and safety of FCN-159, a MEK1/2 inhibitor in pediatric participants with neurofibromatosis type 1: Results from a phase 2 trial.
Journal of Clinical Oncology2024-06-011 citations
FCN-159, a MEK1/2 inhibitor, in patients with advanced melanoma harboring <i>NRAS</i> or <i>NF1</i>mutations: A phase 1B dose-expansion study.
Journal of Clinical Oncology2024-06-011 citations
Phase 1 dose-escalation study to evaluate the safety, tolerability, pharmacokinetics, and anti-tumor activity of FCN-159 in adults with neurofibromatosis type 1-related unresectable plexiform neurofibromas.
2023-07-0311 citations
A multicenter, open-label, single-arm, phase 1 dose-escalation and phase 2 dose-expansion study to evaluate the safety, tolerability, and anti-tumor activity of FCN-159 in adults with neurofibromatosis type 1.
Journal of Clinical Oncology2023-06-01
A multicenter, open-label, single-arm phase 1/2 study to evaluate the safety and efficacy of FCN-159 in pediatric participants with neurofibromatosis type 1.
Journal of Clinical Oncology2023-06-01
Population pharmacokinetics of FCN-159, a MEK1/2 inhibitor, in adult patients with advanced melanoma and neurofibromatosis type 1 (NF1) and model informed dosing recommendations for NF1 pediatrics
Frontiers in Pharmacology2023-01-235 citations
A first-in-human, phase 1a dose-escalation study of the selective MEK1/2 inhibitor FCN-159 in patients with advanced NRAS-mutant melanoma.
2022-09-1316 citations
Abstract CT519: FCN-159, a MEK1/2 inhibitor, in patients with advanced melanoma harboring <i>NRAS</i> mutations: A phase 1A dose-escalation study
Cancer Research2022-06-15
A multicenter, open-label, single-arm, phase 1 dose-escalation study to evaluate the safety, tolerability, and anti-tumor activity of FCN-159 in adults with neurofibromatosis type 1.
Journal of Clinical Oncology2022-06-013 citations
Abstract 1951: FCN-159: A novel, potent and selective oral inhibitor of MEK1/2 for the treatment of solid tumors
Cancer Research2020-08-1514 citations