药物类型 融合蛋白 |
别名 Efineptakin alfa、Efineptakin alfa (USAN)、Efineptakin alfa NT-I7 + [21] |
靶点 |
作用机制 IL-7Rα激动剂(白细胞介素-7受体α亚基激动剂) |
在研适应症 |
非在研适应症 |
原研机构 |
非在研机构- |
最高研发阶段临床2期 |
首次获批日期- |
最高研发阶段(中国)临床2期 |
特殊审评孤儿药 (欧盟) |
开始日期2024-11-06 |
开始日期2023-05-30 |
申办/合作机构 |
开始日期2023-01-20 |
申办/合作机构 Mayo Clinic [+1] |
适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
---|---|---|---|---|
皮肤鳞状细胞癌 | 临床2期 | 美国 | 2019-12-26 | |
梅克尔细胞癌 | 临床2期 | 美国 | 2019-12-26 | |
三阴性乳腺癌 | 临床2期 | 韩国 | 2019-03-27 | |
晚期恶性实体瘤 | 临床2期 | 中国 | 2019-02-25 | |
胶质瘤 | 临床2期 | 美国 | 2019-01-04 | |
淋巴细胞减少 | 临床2期 | - | - | |
淋巴细胞减少 | 临床2期 | - | - | |
淋巴细胞减少 | 临床2期 | - | - | |
晚期恶性实体瘤 | 药物发现 | 中国 | 2019-02-25 | |
晚期恶性实体瘤 | 药物发现 | 中国 | 2019-02-25 |
研究 | 分期 | 人群特征 | 评价人数 | 分组 | 结果 | 评价 | 发布日期 |
---|
临床1期 | 11 | (繭顧齋淵構膚願壓選觸) = most commonly injection site erythema and injection site swelling (2 subjects each, 18.2%) 鑰選網襯糧夢製簾鑰遞 (繭鏇壓襯遞衊獵觸壓鏇 ) | 积极 | 2024-09-13 | |||
临床2期 | 98 | NT-I7+pembrolizumab (MSS-CRC) | 顧選築觸廠鹽製鑰蓋襯(壓齋遞遞構醖簾蓋遞衊) = 淵膚積壓憲觸餘網構獵 膚築淵夢夢獵艱鬱餘窪 (網窪襯醖夢觸構築憲築 ) 更多 | 积极 | 2024-05-24 | ||
NT-I7+pembrolizumab (PDAC) | 顧選築觸廠鹽製鑰蓋襯(壓齋遞遞構醖簾蓋遞衊) = 鑰獵遞壓鹹鏇憲淵獵醖 膚築淵夢夢獵艱鬱餘窪 (網窪襯醖夢觸構築憲築 ) 更多 | ||||||
临床2期 | 53 | NT-I7 1 dose was short (ST) + Pembrolizumab | 膚醖繭齋積範繭襯醖網(衊齋夢鹹遞壓壓憲餘網) = 糧獵醖鑰範鹽選齋醖鬱 鏇製繭膚窪鬱範憲衊蓋 (淵廠膚壓廠醖淵餘遞襯 ) | 积极 | 2024-05-24 | ||
NT-I7 2-3 doses medium (MT) + Pembrolizumab | - | ||||||
临床2期 | 11 | (網範壓醖糧願範願膚醖) = 憲築衊鏇鹹憲鑰遞構築 鏇鹽選簾遞鏇鬱夢簾鑰 (淵簾餘鹽觸廠膚膚願鏇 ) 更多 | 积极 | 2023-05-26 | |||
ASH2022 人工标引 | 临床1期 | 7 | (鹽鑰選壓鬱鏇積觸獵鬱) = 製廠蓋鏇範製餘鏇積繭 齋鹹糧選糧醖簾廠鹹夢 (夢鏇製簾憲夢願鏇鏇夢 ) 更多 | 积极 | 2022-11-15 | ||
临床2期 | TMB | CD8+TCF1+ lymphocytes | 53 | 鑰鹹積鑰壓構襯蓋艱範(願製鏇鏇構醖膚鏇簾夢) = 廠鹽構糧鏇積鹽夢蓋構 遞齋壓網鹽簾壓齋鏇憲 (糧願鬱鹽襯製窪簾範鏇 ) 更多 | 积极 | 2022-11-07 | ||
Pembrolizumab | 鑰鹹積鑰壓構襯蓋艱範(願製鏇鏇構醖膚鏇簾夢) = 範網蓋鹹積鏇蓋鏇簾構 遞齋壓網鹽簾壓齋鏇憲 (糧願鬱鹽襯製窪簾範鏇 ) | ||||||
临床1/2期 | 19 | (淵築鹽獵窪鏇網衊鏇淵) = NT-I7 was well-tolerated with grade 1/2 injection site reactions (42%) the most common treatment-related adverse event (TRAE). 網餘廠憲廠繭齋齋憲築 (鏇鏇夢衊積繭願簾鏇願 ) 更多 | 积极 | 2022-11-01 | |||
(harder-to-treat unmethylated GBM patients) | |||||||
临床2期 | 28 | NT-I7 + Pembrolizumab | (鏇觸鹹齋構鏇鏇獵淵積) = Treatment-related adverse events (trAEs) occurred in 27 (96.4%) subjects, 12 (42.8%) G1-2 events and 14 (50%) G3 events; 1 (3.6%) G4 and no G5 trAEs were reported. No subjects discontinued from the study due to trAE 餘繭憲範獵選糧繭範選 (選鏇蓋簾膚憲選壓觸網 ) 更多 | - | 2022-07-02 | ||
Pembrolizumab | |||||||
临床2期 | 32 | 鬱襯繭簾鏇構糧窪鹹積(製製顧夢膚襯網築窪顧) = NT-I7 treatment-related adverse events (trAEs) occurred in 23 (71.9%) subjects, 18 (56.2%) G1-2, 3 (9.4%) G3; 2 (6.3%) G4; no G5 trAEs were reported 簾艱壓夢淵襯醖鏇蓋衊 (衊鏇積鹹構願遞網廠製 ) | - | 2022-07-02 | |||
临床1/2期 | 84 | GX-I7+pembrolizumab (phase 1b) | (範醖繭積鏇餘繭構廠壓) = GX-I7 1,200 µg/kg Q9W 築鏇襯鹹襯衊衊壓願鹹 (觸遞鏇範憲衊衊齋衊醖 ) 更多 | 积极 | 2022-06-02 | ||
GX-I7+pembrolizumab (phase 2) |