原研机构 |
在研机构 |
非在研机构- |
权益机构- |
最高研发阶段临床1期 |
首次获批日期- |
最高研发阶段(中国)临床1期 |
特殊审评- |
开始日期2023-12-25 |
申办/合作机构 |
开始日期2021-12-28 |
申办/合作机构 |
开始日期2021-12-28 |
申办/合作机构 |
适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
---|---|---|---|---|
髓系肿瘤 | 临床1期 | 中国 | 2021-12-28 | |
血液肿瘤 | 临床1期 | 中国 | 2021-04-13 | |
淋巴瘤 | 临床1期 | 美国 | 2021-01-14 | |
晚期恶性实体瘤 | 临床1期 | 中国 | 2020-07-31 | |
晚期癌症 | 临床1期 | 中国 | 2020-07-20 | |
外周T细胞淋巴瘤 | 临床申请批准 | 中国 | 2022-04-19 |
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 | 24 | 遞襯糧齋鹹願膚鬱繭範(鹽蓋糧鏇窪築顧範願鑰) = Treatment-related adverse events (TRAEs) of any grade occurred in 22 (91.7%) pts. The most frequent TRAEs (≥ 20%) were lymphocyte count decreased (n=15, 62.5%), anaemia (n=15, 62.5%), white blood cell count decreased (n=5, 20.8%) and platelet count decreased (n=5, 20.8%). Grade ≥3 TRAEs occurred in 10 (41.7%) pts, the most frequent grade ≥3 TRAEs (≥ 5%) was lymphocyte count decreased (n=7, 29.2%). Four (16.7%) pts experienced investigator-defined immune-related AEs (irAEs). No grade ≥3 irAEs occurred. No pt experienced TRAE leading to drug discontinuation or death. 積糧襯簾選醖壓繭壓鑰 (鑰範繭願顧構製築選繭 ) | - | 2023-06-08 | |||
临床1期 | 58 | 鬱鏇膚顧廠顧觸觸觸糧(簾鹹餘積襯製鏇製製艱) = 齋窪鹹鏇衊構積構廠鬱 遞憲獵淵壓鑰繭觸鹹蓋 (醖襯憲範簾觸鏇餘築鏇 ) 更多 | 积极 | 2022-06-15 | |||
(at active doses (≥10 mg/kg) and with at least one tumor assessment) | 選蓋構網醖鏇鹽窪網齋(積衊鑰鑰齋窪膚鏇繭蓋) = 顧觸糧鏇壓鏇獵簾艱繭 積淵鏇膚繭襯遞壓襯鬱 (願構憲繭齋鹹鹹製齋齋 ) 更多 |