药物类型 单克隆抗体 |
别名 Claudin18.2 (CLDN18.2) humanized monoclonal antibody(MabSpace Biosciences (Suzhou) Co., Ltd.)、Claudin18.2 monoclonal antibody、Claudin18.2 monoclonal antibody(Mabspace Biosciences) + [5] |
靶点 |
作用方式 抑制剂 |
作用机制 CLDN18.2抑制剂(Claudin 18.2蛋白抑制剂)、ADCC(抗体依赖的细胞毒作用)、补体依赖的细胞毒性作用 |
在研适应症 |
非在研适应症- |
原研机构 |
在研机构 |
非在研机构- |
最高研发阶段临床3期 |
首次获批日期- |
最高研发阶段(中国)临床3期 |
特殊审评孤儿药 (美国) |
适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
---|---|---|---|---|
CLDN18.2阳性胃食管交界处腺癌 | 临床3期 | - | 2023-10-31 | |
CLDN18.2阳性胃腺癌 | 临床3期 | - | 2023-10-31 | |
胃食管交界处腺癌 | 临床3期 | 中国 | 2023-09-01 | |
胃食管交界处腺癌 | 临床3期 | 韩国 | 2023-09-01 | |
胆管癌 | 临床2期 | 中国 | 2022-02-28 | |
晚期胆管癌 | 临床2期 | 中国 | 2022-01-14 | |
转移性胆道癌 | 临床2期 | 中国 | 2020-08-13 | |
转移性实体瘤 | 临床2期 | 中国 | 2020-08-13 | |
胰腺导管腺癌 | 临床2期 | 中国 | 2020-08-13 | |
胃腺癌 | 临床2期 | 中国 | 2020-08-13 |
临床1/2期 | 32 | 齋獵艱廠膚夢齋繭獵廠(衊餘獵壓鹽選壓艱壓網) = All patients experienced treatment-related adverse events (TRAE). The most common TRAE were hypoalbuminaemia, nausea and vomiting, most of them were of CTC AE grade 1 or 2 and manageable. 範淵鑰糧衊糧獵鹹襯範 (繭鏇遞範鹹鹹鏇鑰壓觸 ) 更多 | 积极 | 2024-09-16 | |||
临床1/2期 | 胃食管交界处癌 HER2 Negative | 82 | 膚製範糧廠餘築網窪淵(窪夢獵餘憲窪淵觸糧衊) = 築網憲範繭鏇網遞膚遞 窪衊餘構憲壓願壓鹽選 (顧淵襯製製蓋夢醖鏇齋 ) 更多 | 积极 | 2024-05-24 | ||
临床1/2期 | 64 | 醖簾鬱範廠選窪築膚鬱(窪選獵構網淵繭餘鏇範) = nausea (70.3%), vomiting (53.1%) and hypoalbuminemia (75%) with grade 3 being 1.6% each 齋築願獵遞鬱簾觸鏇願 (積網獵構繭窪簾範衊構 ) | 积极 | 2023-10-23 | |||
(6 mg/kg in the dose expansion phase) | |||||||
临床1/2期 | 实体瘤 CLDN18.2 Positive | 248 | 廠鏇膚願鹽顧糧築醖淵(築艱顧窪遞餘繭獵積鹽) = Model simulated steady state trough concentration will achieve in vitro ADCC assay EC95 and in vivo MKN45-CLDN18.2 tumor growth inhibition model EC50 in most subjects following 6mg/kg Q3W and 4mg/kg Q2W. 獵夢鹽構膚顧淵衊範製 (選構願願鹹遞夢廠願夢 ) 更多 | 积极 | 2023-10-23 | ||
临床1/2期 | 64 | osemitamab+CAPOX | 夢築網願製廠鏇遞觸鑰(範繭窪網選壓鑰醖遞選) = Most of them were grade 1 or 2, only one patient experienced grade 3 nausea and vomiting. 鹹選觸鑰窪衊繭簾憲鏇 (鑰願鹽憲膚範廠積憲範 ) | 积极 | 2023-06-30 | ||
临床1期 | 晚期癌症 一线 | 64 | Osemitamab+CAPOX | 製顧憲壓構繭構艱獵衊(願構獵壓鑰憲網顧製鏇) = Nausea (65.4%), vomiting (46.2%) and hypoalbuminemia (65.4%) were the most common adverse events related to TST001 at dose of 6mg/kg in 52 patients (3 patients in dose escalation and 49 patients in dose expansion), most of them were grade 1 or 2 (only one patient experienced grade 3 nausea and vomiting, and one experienced grade 3 hypoalbuminemia). 鑰範鏇鏇餘鬱獵觸糧製 (鹽獵鏇範願簾繭顧鏇範 ) | 积极 | 2023-05-26 | |
Osemitamab+CAPOX | |||||||
临床1期 | 胃食管交界处癌 一线 | 26 | CAPOX+TST001 | 餘齋鹽窪鑰糧鏇鹽艱膚(艱鹹糧醖鏇蓋醖鏇鹹製) = Most are grade 1-2, including nausea, hypoalbuminemia, anemia, vomiting, and elevated AST 醖廠選鹹顧遞積構糧憲 (夢製淵鏇糧觸網網壓淵 ) | 积极 | 2022-06-02 |