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FCN-159 inhibits MAP2K1/2 (MEK1/2), potentially resulting in reduced proliferation and increased cell cycle arrest and apoptosis in tumor cells, and inhibition of tumor growth (Cancer Res 2020;80(16 Suppl):Abstract nr 1951).
|Drug Name||Trade Name||Synonyms||Drug Classes||Drug Description|
|FCN-159||FCN159|FCN 159||MEK1 Inhibitor 25 MEK2 Inhibitor 23||FCN-159 inhibits MAP2K1/2 (MEK1/2), potentially resulting in reduced proliferation and increased cell cycle arrest and apoptosis in tumor cells, and inhibition of tumor growth (Cancer Res 2020;80(16 Suppl):Abstract nr 1951).|
|Molecular Profile||Indication/Tumor Type||Response Type||Therapy Name||Approval Status||Evidence Type||Efficacy Evidence||References|
|NRAS mutant||Advanced Solid Tumor||predicted - sensitive||FCN-159||Preclinical - Pdx||Actionable||In a preclinical study, FCN-159 inhibited tumor growth in patient-derived xenograft (PDX) models harboring NRAS mutations (Cancer Res 2020;80(16 Suppl):Abstract nr 1951).||detail...|
|NRAS act mut||melanoma||predicted - sensitive||FCN-159||Phase I||Actionable||In a Phase I trial (FCN-159-001), FCN-159 treatment was well tolerated in melanoma patients harboring NRAS activating mutations and resulted in an objective response rate (ORR) of 19% (4/21, all partial responses), a clinical benefit rate (CBR) of 52.4% (11/21), and a median progression-free survival (mPFS) of 3.8 mo across all doses tested, and a CBR of 50% (3/6), mPFS of 3.8 mo at the RP2D dose of 12mg (PMID: 36113242; NCT03932253).||36113242|
|Clinical Trial||Phase||Therapies||Title||Recruitment Status||Covered Countries||Other Countries|
|NCT04954001||Phase Ib/II||FCN-159||Study to Evaluate the Safety, Tolerability, PK Characteristics and Anti-tumor Activity of FCN-159 in Adult and Pediatric Participants With Neurofibromatosis Type 1||Recruiting||USA | ESP||1|