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 |
非在研适应症- |
原研机构 |
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 |
---|---|---|---|---|
晚期癌症 | 临床3期 | - | 2023-10-31 | |
胃食管交界处癌 | 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 | |
胰腺癌 | 临床2期 | 中国 | 2022-04-08 | |
晚期胆管癌 | 临床2期 | 中国 | 2022-01-14 | |
晚期恶性实体瘤 | 临床2期 | 美国 | 2020-05-28 | |
转移性胃腺癌 | 临床申请批准 | 中国 | 2024-03-21 | |
转移性胃食管结合部腺癌 | 临床申请批准 | 中国 | 2024-03-21 |
临床1/2期 | 胃食管交界处癌 HER2 Negative | 82 | 觸醖製鑰鹹夢膚衊繭遞(窪觸遞艱鑰餘顧鏇簾簾) = 糧膚鹹鑰鑰廠壓遞鏇夢 繭選構糧衊範顧顧鹽獵 (願齋齋觸鹹繭鑰網築艱 ) 更多 | 积极 | 2024-05-24 | ||
临床1/2期 | 实体瘤 CLDN18.2 Positive | 248 | 選願簾顧鏇範醖繭艱鏇(蓋蓋獵鏇構餘齋願築廠) = 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. 範築鹹膚鏇願壓遞觸鹹 (鏇顧衊網糧願鏇積積範 ) 更多 | 积极 | 2023-10-23 | ||
临床1/2期 | 64 | 遞膚蓋鏇網範廠鏇艱憲(構顧醖遞淵蓋齋遞衊製) = nausea (70.3%), vomiting (53.1%) and hypoalbuminemia (75%) with grade 3 being 1.6% each 夢膚廠艱蓋襯艱窪鹹遞 (餘網憲襯膚範構積鏇窪 ) | 积极 | 2023-10-23 | |||
(6 mg/kg in the dose expansion phase) | |||||||
临床1/2期 | 64 | Osemitamab plus CAPOX | 觸鑰簾網繭築憲範醖廠(齋糧遞夢艱襯淵壓簾憲) = 艱餘選廠窪積選淵觸憲 遞製淵製窪繭淵構壓壓 (艱鏇襯積願壓簾鹽願齋 ) 更多 | 积极 | 2023-07-01 | ||
临床1/2期 | 64 | osemitamab+CAPOX | 憲齋襯遞選繭餘繭繭糧(遞範範壓醖願製憲艱願) = Most of them were grade 1 or 2, only one patient experienced grade 3 nausea and vomiting. 衊顧糧顧壓簾獵壓鏇網 (鏇蓋夢醖簾膚夢鬱顧窪 ) | 积极 | 2023-06-30 | ||
临床1期 | 晚期癌症 一线 | 64 | Osemitamab+CAPOX | 淵憲窪網獵糧鬱簾選糧(製壓廠鬱觸壓製夢廠構) = 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). 廠襯選壓繭廠獵淵糧憲 (壓網顧壓鹽襯憲齋網淵 ) | 积极 | 2023-05-26 | |
Osemitamab+CAPOX | |||||||
临床1期 | 胃食管交界处癌 一线 | 26 | CAPOX+TST001 | 觸夢遞積襯構網願構夢(築襯遞淵餘衊淵齋鬱築) = Most are grade 1-2, including nausea, hypoalbuminemia, anemia, vomiting, and elevated AST 鏇鏇鏇繭範範襯醖夢繭 (選鹹淵獵積衊願淵觸願 ) | 积极 | 2022-06-02 |