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更新于：2026-04-11
Osemitamab
Claudin18.2 (CLDN18.2)人源化单克隆抗体 (苏州迈博斯)
更新于：2026-04-11
概要
基本信息
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 |
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) |
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结构/序列
Sequence Code 631397381H
来源: *****
Sequence Code 631397382L
来源: *****
关联
6
项与 Claudin18.2 (CLDN18.2)人源化单克隆抗体 (苏州迈博斯) 相关的临床试验NCT05608785
Single-center, Multi-cohort Exploratory Phase Ib/II Clinical Study of First-line Treatment of Unresectable Locally Advanced/Advanced Adenocarcinoma of the Stomach or Gastroesophageal Junction Based on Different Genotypes
NCT05190575
An Open-label, Single-arm Phase II Study to Evaluate the Efficacy and Safety of TST001 for Patients With CLDN18.2 Positive Previously Treated Unresectable Advanced or Metastatic Biliary Tract Cancer
ChiCTR2100054990
An open-label, single-arm phase II clinical study evaluating the efficacy and safety of TST001 in the treatment of unresectable advanced or metastatic CLDN18.2-positive cholangiocarcinoma
100 项与 Claudin18.2 (CLDN18.2)人源化单克隆抗体 (苏州迈博斯) 相关的临床结果
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100 项与 Claudin18.2 (CLDN18.2)人源化单克隆抗体 (苏州迈博斯) 相关的转化医学
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100 项与 Claudin18.2 (CLDN18.2)人源化单克隆抗体 (苏州迈博斯) 相关的专利（医药）
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5
项与 Claudin18.2 (CLDN18.2)人源化单克隆抗体 (苏州迈博斯) 相关的文献（医药）2025-02-01Journal of Gastrointestinal Oncology
Expression of Claudin18.2 in metastatic lesions in peritoneum of gastric cancer
Article
作者: Sata, Naohiro ; Hosoya, Yoshinori ; Matsumoto, Shiro ; Saito, Shin ; Ohzawa, Hideyuki ; Miyato, Hideyo ; Kawashima, Rie ; Yamaguchi, Hironori ; Saito, Akira ; Kitayama, Joji ; Kurashina, Kentaro
Background:
Patients with advanced gastric cancer (GC) with peritoneal involvement have a dismal prognosis. Recent clinical trials have shown that anti-Claudin18.2 (CLDN18.2) antibody (zolbetuximab) enhances survival in patients with GC expressing high levels of CLDN18.2. However, the effectiveness of the zolbetuximab in patients with peritoneal metastases (PMs) remains unclear. In this study, we aimed to evaluate the expression of CLDN18.2 in disseminated lesions to assess the clinical utility of zolbetuximab in the treatment of GC with PM.
Methods:
In 42 patients diagnosed with stage IV GC with PM, biopsy samples from the primary tumors and peritoneal metastatic nodules were collected and immunostained using the specific antibody (43-14A, Ventana). The expression of CLDN18.2 was comparatively evaluated based on staining intensity and the proportion of positive cells.
Results:
Positive immunoreactivity of CLDN18.2 was observed in 37 (88%) of the primary tumors. Specifically, CLDN18.2 positivity was identified in 26 (62%) or 12 (29%) patients based on moderate to strong membrane staining in at least 40% or 75% of tumor cells, respectively. In comparison, the staining intensity in tumor cells was consistently reduced in PM across all patients. CLDN18.2 expression was absent in PM of 29 (69%) patients, while 3 (7.1%) cases were determined to be CLDN18.2-positive based on a cutoff value of 40% for high staining. This trend was particularly pronounced in cases with undifferentiated type and human epidermal growth factor receptor 2 (HER-2) negative primary tumors.
Conclusions:
Although CLDN18.2 expression in PM mirrored that in primary lesions, the levels were generally reduced. When zolbetuximab is used for GC patients with peritoneal involvement, it is preferable to assess the expression of CLDN18.2 in the disseminated lesions.
2024-08-01DRUGS
Zolbetuximab: First Approval
Review
作者: Keam, Susan J
Zolbetuximab (VYLOY™), a recombinant, chimeric, anti-claudin 18.2 (CLDN18.2) monoclonal antibody (mAb), is being developed by Astellas Pharma Inc. for the treatment of patients with HER2-negative (HER2-), CLDN18.2-positive (CLDN18.2+) advanced gastric or gastroesophageal junction (GEJ) adenocarcinoma and CLDN18.2+ advanced pancreatic adenocarcinoma. In March 2024, zolbetuximab was approved in Japan for the treatment of patients with HER2-, CLDN18.2+ unresectable, advanced/recurrent gastric cancer (the gastric cancer indication includes GEJ cancer). Zolbetuximab is also undergoing regulatory review for HER2-, CLDN18.2+ advanced gastric or GEJ adenocarcinoma in the USA, the EU, China, Australia and several other countries. This article summarizes the milestones in the development of zolbetuximab leading to this first approval for the treatment of patients with CLDN18.2+ gastrointestinal malignancies.
2023-04-01Journal of pharmaceutical analysis
Development of a CLDN18.2-targeting immuno-PET probe for non-invasive imaging in gastrointestinal tumors
Article
作者: Yang, Zhi ; Zhang, Fan ; Li, Dapeng ; Ding, Jin ; Chen, Yan ; Hou, Xingguo ; Wang, Zilei ; Liu, Jiayue ; Li, Hongjun ; Qian, Xueming ; Yu, Steven ; Teng, Fei ; Zhu, Hua ; Gu, Yi
Claudin18.2 (CLDN18.2) is a tight junction protein that is overexpressed in a variety of solid tumors such as gastrointestinal cancer and oesophageal cancer. It has been identified as a promising target and a potential biomarker to diagnose tumor, evaluate efficacy, and determine patient prognosis. TST001 is a recombinant humanized CLDN18.2 antibody that selectively binds to the extracellular loop of human Claudin18.2. In this study, we constructed a solid target radionuclide zirconium-89 (89Zr) labled-TST001 to detect the expression of in the human stomach cancer BGC823CLDN18.2 cell lines. The [89Zr]Zr-desferrioxamine (DFO)-TST001 showed high radiochemical purity (RCP, >99%) and specific activity (24.15 ± 1.34 GBq/μmol), and was stable in 5% human serum albumin, and phosphate buffer saline (>85% RCP at 96 h). The EC50 values of TST001 and DFO-TST001 were as high as 0.413 ± 0.055 and 0.361 ± 0.058 nM (P > 0.05), respectively. The radiotracer had a significantly higher average standard uptake values in CLDN18.2-positive tumors than in CLDN18.2-negative tumors (1.11 ± 0.02 vs. 0.49 ± 0.03, P = 0.0016) 2 days post injection (p.i.). BGC823CLDN18.2 mice models showed high tumor/muscle ratios 96 h p.i. with [89Zr]Zr-DFO-TST001 was much higher than those of the other imaging groups. Immunohistochemistry results showed that BGC823CLDN18.2 tumors were highly positive (+++) for CLDN18.2, while those in the BGC823 group did not express CLDN18.2 (-). The results of ex vivo biodistribution studies showed that there was a higher distribution in the BGC823CLDN18.2 tumor bearing mice (2.05 ± 0.16 %ID/g) than BGC823 mice (0.69 ± 0.02 %ID/g) and blocking group (0.72 ± 0.02 %ID/g). A dosimetry estimation study showed that the effective dose of [89Zr]Zr-DFO-TST001 was 0.0705 mSv/MBq, which is within the range of acceptable doses for nuclear medicine research. Taken together, these results suggest that Good Manufacturing Practices produced by this immuno-positron emission tomography probe can detect CLDN18.2-overexpressing tumors.
217
项与 Claudin18.2 (CLDN18.2)人源化单克隆抗体 (苏州迈博斯) 相关的新闻（医药）2026-04-05
·信狐药迅
100 项与 Claudin18.2 (CLDN18.2)人源化单克隆抗体 (苏州迈博斯) 相关的药物交易
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研发状态
10 条进展最快的记录, 后查看更多信息
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| 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 | - | 2026-06-30 | |
| 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 | |
| 胆道癌 | 临床2期 | 中国 | 2022-01-07 | |
| CLDN18.2阳性晚期恶性实体肿瘤 | 临床2期 | 中国 | 2022-01-07 | |
| 肺腺癌 | 临床2期 | 中国 | 2020-08-13 | |
| 结直肠癌 | 临床2期 | 中国 | 2020-08-13 | |
| HER2阴性胃食管结合部腺癌 | 临床2期 | 中国 | 2020-08-13 |
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临床结果
临床结果
适应症
分期
评价
查看全部结果
临床1/2期 | 66 | (CLDN18.2 ≥ 40%, ≥ 2+, PD‑L1 all comers) | 築鬱鏇築顧鏇積觸醖廠(齋鹽衊願艱憲壓築壓醖) = 鹹獵鹽簾蓋願醖願構繭 獵選夢獵簾遞鬱積廠網 (遞廠壓構鬱製醖繭積齋 ) 更多 | 积极 | 2025-12-05 | ||
(CLDN18.2 < (40%, ≥ 2+), PD‑L1 all comers) | 築鬱鏇築顧鏇積觸醖廠(齋鹽衊願艱憲壓築壓醖) = 憲鏇鏇鑰積觸鑰簾選鹽 獵選夢獵簾遞鬱積廠網 (遞廠壓構鬱製醖繭積齋 ) 更多 | ||||||
临床1/2期 | 82 | 獵廠觸製築鹹廠築鬱糧(積鑰蓋艱製網製壓觸鹹) = The safety profile was similar with the previously presented data. 鹽衊淵齋壓獵鬱繭鏇繭 (夢鑰糧願製夢淵膚願蓋 ) 更多 | 积极 | 2025-05-30 | |||
(CLDN18.2 expression ≥40% (2+ intensity) and known PD-L1 CPS) | |||||||
临床1/2期 | 32 | 鏇淵構艱製齋網鹽齋廠(夢築選範鏇廠積鏇顧積) = 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. 範築網願齋顧廠蓋願襯 (築蓋網齋襯夢艱簾積繭 ) 更多 | 积极 | 2024-09-16 | |||
临床1/2期 | 胃食管交界处癌 HER2 Negative | 82 | 鹹鏇鹹壓遞膚壓簾衊顧(鏇齋憲餘鹹膚廠糧醖鹽) = 顧顧構餘獵糧壓窪醖網 衊蓋夢衊簾醖壓願齋衊 (顧觸壓廠願糧觸簾選製 ) 更多 | 积极 | 2024-05-24 | ||
临床1/2期 | 64 | 築築簾齋簾鹽醖網艱選(餘鏇遞窪衊簾夢願顧範) = nausea (70.3%), vomiting (53.1%) and hypoalbuminemia (75%) with grade 3 being 1.6% each 網憲鑰鹹襯遞鹽艱遞襯 (襯艱構選齋醖鹽遞壓網 ) | 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 | 廠壓夢鹹獵遞簾積願積(衊壓鏇醖鬱遞醖製窪鏇) = 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. 顧願網簾艱齋憲壓憲襯 (願衊鑰膚網簾構襯積獵 ) 更多 | 积极 | 2023-10-23 | ||
临床1/2期 | 64 | osemitamab+CAPOX | 製醖蓋遞簾選膚廠獵網(鏇鏇窪選鏇鏇製廠鏇廠) = Most of them were grade 1 or 2, only one patient experienced grade 3 nausea and vomiting. 襯廠選繭艱鏇積觸淵製 (壓淵願壓願鹹鹽範糧遞 ) | 积极 | 2023-06-30 | ||
临床1期 | 晚期癌症 一线 | 64 | Osemitamab+CAPOX | 製願築廠餘網膚廠壓繭(窪鏇膚醖簾顧壓願觸壓) = 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). 鏇衊壓築鑰窪衊願鹽鬱 (網襯鑰鹽鑰蓋築膚淵觸 ) | 积极 | 2023-05-26 | |
Osemitamab+CAPOX | |||||||
临床1期 | 胃食管交界处癌 一线 | 26 | CAPOX+TST001 | 淵憲選壓壓製築膚鏇襯(網鏇觸築鑰鏇襯鹽夢選) = Most are grade 1-2, including nausea, hypoalbuminemia, anemia, vomiting, and elevated AST 網鏇衊淵壓襯鹹齋衊網 (齋網糧衊衊遞糧窪觸憲 ) | 积极 | 2022-06-02 |
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