预约演示
更新于：2026-04-04
Alcestobart
艾克苏拜单抗
更新于：2026-04-04
概要
基本信息
药物类型 单克隆抗体 |
别名 LBL 007、LBL-007、LBL007 |
靶点 |
作用方式 抑制剂 |
作用机制 LAG3抑制剂(淋巴细胞活化基因3蛋白抑制剂) |
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3期 |
首次获批日期- |
最高研发阶段(中国)临床3期 |
特殊审评- |
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结构/序列
Sequence Code 319494283H
来源: *****
Sequence Code 319494284L
来源: *****
关联
13
项与 艾克苏拜单抗 相关的临床试验NCT07099430
An Open-label, Multicenter Phase Ib/II Clinical Study to Evaluate the Efficacy and Safety of LBL-024 Monotherapy, LBL-024 in Combination With LBL-007 or Toripalimab in Patients With Advanced Melanoma
NCT06010303
A Phase 2, Randomized, Active-Controlled, Open-Label Study to Evaluate the Efficacy and Safety of LBL-007 in Combination With Tislelizumab Plus Chemotherapy as First-Line Treatment in Patients With Unresectable Locally Advanced or Metastatic Esophageal Squamous Cell Carcinoma
NCT05909904
A Randomized, Phase 2, Open-Label, Multi-Arm Study of Tislelizumab in Combination With Investigational Agents as First-Line Treatment in Patients With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma
100 项与 艾克苏拜单抗 相关的临床结果
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100 项与 艾克苏拜单抗 相关的转化医学
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100 项与 艾克苏拜单抗 相关的专利（医药）
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2
项与 艾克苏拜单抗 相关的文献（医药）2025-05-01Xi bao yu fen zi mian yi xue za zhi = Chinese journal of cellular and molecular immunology
[A novel fully human LAG-3 monoclonal antibody LBL-007 combined with PD-1 antibody inhibits proliferation, migration and invasion of tumor cells via blocking NF-κB pathway].
Article
作者: Zhou, Lijun ; Wu, Chenglin ; Zhou, Huinan ; Qin, Kewei ; Liu, Jianfei
Objective To investigate the effects of LBL-007, a novel fully human lymphocyte activation gene 3 (LAG-3) monoclonal antibody, in combination with programmed cell death protein 1 (PD-1) antibody, on the invasion, migration and proliferation of tumor cells, and to elucidate the underlying mechanisms. Methods Human lymphocyte cells Jurkat were co-cultured with A549 and MGC803 tumor cell lines and treated with the isotype control antibody human IgG, LBL-007, anti-PD-1 antibody BE0188, or tumor necrosis factor-alpha (TNF-α, the NF-κB signaling pathway agonist). Tumor cell proliferation was assessed using a colony formation assay; invasion was measured by TranswellTM assay; migration was evaluated using a wound healing assay. Western blotting was employed to determine the expression levels of NF-κB pathway-related proteins: IκB inhibitor kinase alpha (Ikkα), phosphorylated Ikkα (p-IKKα), NF-κB subunit p65, phosphorylated p65 (p-p65), NF-κB Inhibitor Alpha (IκBα), phosphorylated IκBα (p-IκBα), matrix metalloproteinase 9 (MMP9), and MMP2. Results Compared with the control and IgG isotype groups, LBL-007 and BE0188 significantly reduced tumor cell proliferation, invasion, and migration. They also decreased the phosphorylation of p-IKKα, p-p65 and p-IκBα, and the expression of MMP9 and MMP2 of tumor cells in the co-culture system. The combined treatment of LBL-007 and BE0188 enhanced inhibitory effects. Treatment with the NF-κB signaling pathway agonist TNF-α reversed the suppressive effects of LBL-007 and BE0188 on tumor cell proliferation, invasion, migration, and NF-κB signaling. Conclusion LBL-007 and anti-PD-1 antibody synergistically inhibit the invasion, migration, and proliferation of A549 and MGC803 tumor cells by blocking the NF-κB signaling pathway.
Journal of Hematology & Oncology
Anti-LAG-3 antibody LBL-007 plus anti-PD-1 antibody toripalimab in advanced nasopharyngeal carcinoma and other solid tumors: an open-label, multicenter, phase Ib/II trial
Article
作者: Zhao, Yuan-Yuan ; Huang, Yan ; Kang, Xiao-Qiang ; Li, Gui-Ling ; Hu, De-Sheng ; Chen, Gang ; Wang, Hui-Li ; Cai, Sheng-Li ; Ba, Yi ; Fang, Wen-Feng ; Zhou, Ting ; Zhang, Ya-Xiong ; Wang, Wei ; Lin, Jin-Guan ; Sun, Dong-Chen ; Yang, Yun-Peng ; Zhu, Hai-Sheng ; Zhang, Li ; Deng, Chao ; Fu, Zhi-Chao ; Wang, Zhen ; Zhao, Hong-Yun ; Luo, Su-Xia
PURPOSE:
Open-label phase Ib/II study to investigate the safety and efficacy of LBL-007, an anti-LAG-3 antibody, plus toripalimab, an anti-PD-1 antibody, in patients with previously treated advanced nasopharyngeal carcinoma (NPC) and other solid tumors.
METHODS:
Patients with advanced tumors refractory to prior standard therapies were enrolled. In phase Ib, patients received LBL-007 200 mg or 400 mg and toripalimab 240 mg intravenously once every 3 weeks. In phase II, all patients received LBL-007 at the recommended phase II dose (RP2D) and toripalimab 240 mg intravenously once every 3 weeks. The primary end points were safety in phase Ib and objective response rate (ORR) in phase II. The exploratory end point was the predictive capability of LAG-3 and PD-L1 expression for efficacy.
RESULTS:
Between November 30, 2021, and December 1, 2023, 80 patients were enrolled, including 30 (37.5%) with NPC and 50 (62.5%) with other tumors. Median follow-up was 26.0 months. In Phase Ib, LBL-007 was administered at 200 mg to four patients and 400 mg to six patients, with no dose-limiting toxicities observed. Therefore, the 400 mg dose of LBL-007 was established as the RP2D and administered to 70 patients in phase II. Nine (11.3%) of 80 patients had grade 3 or 4 treatment-related adverse events, the most common of which included anemia (2.5%), hyponatremia (2.5%), increased alanine aminotransferase (2.5%), increased aspartate aminotransferase (1.3%), and fatigue (1.3%). Eight patients (10.0%) had treatment-related serious adverse events. No treatment-related deaths were reported. In immunotherapy-naive NPC patients (n = 12), ORR was 33.3%, disease control rate (DCR) was 75%, and median progression-free survival (PFS) was 10.8 months (95% CI, 1.3 to not estimated). In IO-treated NPC patients (n = 17), ORR was 11.8%, DCR was 64.7%, and median PFS was 2.7 months (95% CI, 1.4 to 4.9). For other tumors, ORRs were 15.8% in immunotherapy-naive patients and 3.7% in immunotherapy-treated patients. Patients with ≥ 2 + LAG-3 expression had a higher ORR of 28.0%, compared to 7.7% in those with < 2 + LAG-3 expression.
CONCLUSION:
LBL-007 plus toripalimab exhibited a manageable safety profile in patients with advanced solid tumors and demonstrated promising antitumor activity in NPC, especially in immunotherapy-naive patients. These findings warrant further validation in future studies.
78
项与 艾克苏拜单抗 相关的新闻（医药）2026-04-02
2026-03-26
2026-03-26
100 项与 艾克苏拜单抗 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 |
|---|---|---|---|---|
| 肿瘤 | 临床3期 | 美国 | 2019-12-19 | |
| 肿瘤 | 临床3期 | 中国 | 2019-12-19 | |
| 肿瘤 | 临床3期 | 日本 | 2019-12-19 | |
| 肿瘤 | 临床3期 | 澳大利亚 | 2019-12-19 | |
| 肿瘤 | 临床3期 | 法国 | 2019-12-19 | |
| 肿瘤 | 临床3期 | 意大利 | 2019-12-19 | |
| 肿瘤 | 临床3期 | 马来西亚 | 2019-12-19 | |
| 肿瘤 | 临床3期 | 新西兰 | 2019-12-19 | |
| 肿瘤 | 临床3期 | 波兰 | 2019-12-19 | |
| 肿瘤 | 临床3期 | 韩国 | 2019-12-19 |
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临床结果
临床结果
适应症
分期
评价
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临床2期 | 非小细胞肺癌 新辅助 | 121 | (PD-L1 TC ≥50%, TIS (anti-PD-1)) | 構築醖繭淵憲獵膚築壓(壓醖蓋願壓觸觸窪遞遞) = 衊繭壓積積繭製醖襯膚 齋遞憲製衊繭觸憲淵遞 (淵壓衊醖鹹獵齋遞網選 ) 更多 | 积极 | 2025-09-08 | |
(PD-L1 TC ≥50%, TIS plus ociperlimab (anti-TIGIT)) | 構築醖繭淵憲獵膚築壓(壓醖蓋願壓觸觸窪遞遞) = 淵鬱醖範積淵鹹簾襯淵 齋遞憲製衊繭觸憲淵遞 (淵壓衊醖鹹獵齋遞網選 ) 更多 | ||||||
临床2期 | 复发性鼻咽癌 一线 | 维持 | 42 | 繭構廠製製選鹽鑰繭膚(觸廠蓋襯觸獵夢範襯鏇) = 16 patients (38.1%) experienced LBL-007 treatment related SAEs 廠襯憲夢選積觸鑰簾襯 (糧遞願壓積齋醖觸齋顧 ) 更多 | 积极 | 2025-05-30 | ||
临床1/2期 | 63 | 齋繭壓製齋膚淵壓夢糧(壓膚製壓鹹鹽選鏇積衊) = None 製鬱網壓餘廠鹹襯範糧 (構艱鹹窪襯餘鹹遞鹽襯 ) 更多 | 积极 | 2024-05-24 | |||
临床1/2期 | 80 | 獵範鏇構醖鏇願簾願襯(築製築鏇鹽網艱遞範範) = 齋窪獵範糧淵觸壓夢獵 鏇範壓鏇構獵網淵齋蓋 (繭憲簾網鹽繭範選獵糧 ) 更多 | 积极 | 2024-04-05 | |||
临床1期 | 110 | 鹹構簾糧鏇廠壓淵網鬱(鹽範襯醖餘繭鹽遞窪繭) = 膚糧鬱窪鏇選淵膚網齋 鑰積齋齋願憲糧構築顧 (鏇製鹹淵艱餘齋製鏇簾 ) 更多 | 积极 | 2023-05-26 | |||
鹹構簾糧鏇廠壓淵網鬱(鹽範襯醖餘繭鹽遞窪繭) = 構鑰鑰廠醖蓋構憲廠餘 鑰積齋齋願憲糧構築顧 (鏇製鹹淵艱餘齋製鏇簾 ) 更多 | |||||||
临床1期 | 37 | 餘艱製衊願衊選顧簾艱(網網選餘鹹構選壓淵壓) = 壓齋獵範鏇廠觸網選繭 顧蓋鹽夢鏇醖選繭願觸 (壓鬱積簾繭鏇醖製淵憲 ) | - | 2022-06-02 | |||
餘艱製衊願衊選顧簾艱(網網選餘鹹構選壓淵壓) = 艱鏇壓淵糧積築鑰鏇憲 顧蓋鹽夢鏇醖選繭願觸 (壓鬱積簾繭鏇醖製淵憲 ) |
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