Study to Evaluate the Safety, Tolerability, PK Characteristics and Anti-tumor Activity of FCN-159 in Adult and Pediatric Participants With Neurofibromatosis Type 1

Summary

FCN-159 is a highly active MEK1/2 inhibitor that was designed, synthesized and screened on the basis of the structure of trametinib. FCN-159 is an orally available and highly potent selective inhibitor of MEK1/2, which is expected to be a targeted therapy for the treatment of advanced solid tumors and neurofibromatosis type 1.

Timeline

Start

2021-03-26

Primary completion

2025-02-28

Completion

2025-03-30

Publications

• Hu X, Wu Z, Wang J, Li W, Zeng K, Li Y, Tao J, Guan Z, Kang Z, Xu Z, Ma Y, Yang L, Wang X, Han P, Lin H, Diao L, Tan Y, Zhong W, Hui AM, Li C, Lin X. Phase 1 Study of Luvometinib Use in Pediatric Patients with Neurofibromatosis Type 1-Related Unresectable Plexiform Neurofibromas. Target Oncol. 2025 Nov;20(6):991-1001. doi: 10.1007/s11523-025-01176-y. Epub 2025 Oct 26.
• Hu X, Li W, Zeng K, Xu Z, Li C, Kang Z, Li S, Huang X, Han P, Lin H, Hui AM, Tan Y, Diao L, Li B, Wang X, Wu Z, Lin X. 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. BMC Med. 2023 Jul 3;21(1):230. doi: 10.1186/s12916-023-02927-2.

Drugs

Indications