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Authors
Hu, Xiaojie
Wu, Zhuli
Wang, Jinhu
Li, Wenbin
Zeng, Kang
Li, Yanling
Tao, Juan
Guan, Zhonghai
Kang, Zhuang
Xu, Zhongyuan
Ma, Yaohui
Yang, Liu
Wang, Xingli
Han, Pu
Lin, Hongmei
Diao, Lei
Tan, Yan
Zhong, Wen
Hui, Ai-Min
Li, Changxing
Lin, Xiaoxi
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Clinical Trials BETA
Clinical trials referenced in this document:
nct04954001 at ClinicalTrials.govDocuments that mention this clinical trial
Phase 1 Study of Luvometinib Use in Pediatric Patients with Neurofibromatosis Type 1-Related Unresectable Plexiform Neurofibromas
https://doi.org/10.1007/s11523-025-01176-y
Efficacy and safety of FCN-159, a MEK1/2 inhibitor in pediatric participants with neurofibromatosis type 1: Results from a phase 2 trial.
https://doi.org/10.1200/jco.2024.42.16_suppl.3096
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.
https://doi.org/10.1200/jco.2023.41.16_suppl.10023
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.
https://doi.org/10.1200/jco.2023.41.16_suppl.3103
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Funding
Funding for this research was provided by:
Fosun Pharma, Shanghai, China
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Article History
Received: 25 April 2025
Accepted: 1 September 2025
First Online: 26 October 2025
Declarations
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: At the time of study conduct, Zhuli Wu, Pu Han, Lei Diao, Yan Tan and Ai-Min Hui were employees of Fosun Pharma, Shanghai, China. Xingli Wang, Hongmei Lin, and Wen Zhong are employees of Fosun Pharma, Shanghai, China. Xiaojie Hu, Jinhu Wang, Wenbin Li, Kang Zeng, Yanling Li, Juan Tao, Zhonghai Guan, Zhuang Kang, Zhongyuan Xu, Yaohui Ma, Liu Yang, Changxing Li, and Xiaoxi Lin declare that they have no conflicts of interest that might be relevant to the contents of this manuscript.
: The study was conducted in accordance with the principles of the Declaration of Helsinki and Good Clinical Practice guidelines and with the approval of the local Institutional Review Board/Independent Ethics Committee at the leading study site (Shanghai Ninth People’s Hospital, approval no. SH9H-2020-C25-6). All patients provided written informed consent.
: Written informed consent for publication of the clinical images in Fig. was obtained from the patient.
: De-identified data underlying this work are available from the corresponding author on reasonable request.
: Not applicable.
: X.L., X.H., Z.W., and A.-M.H. contributed to study design and conception. X.H., Z.W., J.W., W.L., K.Z., Y.L., J.T., Z.G., Z.K., Z.X., Y.M., L.Y., X.W., P.H., and H.L. contributed to study investigation. X.H., Z.W., P.H., H.L., L.D., Y.T., and W.Z. contributed to formal analysis of data. All authors contributed to interpretation of study results, and in the drafting, critical review, and approval of the final version of the manuscript.
