MEK Inhibitor FCN-159 To Treat Advanced Melanoma With NRAS-aberrant (Ia) and NRAS-mutant (Ib)
Status:
Recruiting
Trial end date:
2023-03-01
Target enrollment:
Participant gender:
Summary
Melanoma is one of the most common cutaneous cancers worldwide. Activating mutations in RAS
oncogenes are found in a third of all human cancers and NRAS mutations are found in 15%-20%
of melanomas. Acquisition of a functional mutation in NRAS results in activation of the Ras /
Raf / MEK / ERK signaling pathway leading to unconstrained cell growth and cell
transformation. NRAS mutation status was identified as an independent poor prognostic factor
in stage IV melanoma. No drug was approved to treat melanoma patients with NRAS mutation or
amplification until now. FCN-159, an oral and potent MEK1/2 inhibitor, has more than 10 folds
higher selectivity against activated MEK1 and MEK2 compared with trametinib, and has
demonstrated significant antitumor growth inhibition in two patient-derived xenograft (PDX)
models with NRAS mutation.This is the first in human study to evaluate the safety and
anti-tumor activity in patients.
Phase:
Phase 1
Details
Lead Sponsor:
Shanghai Fosun Pharmaceutical Development Co, Ltd.