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更新于：2025-11-28
Negalstobart
更新于：2025-11-28
概要
基本信息
药物类型 单克隆抗体 |
别名 IBI-110 |
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 |
权益机构- |
最高研发阶段临床2期 |
首次获批日期- |
最高研发阶段(中国)临床2期 |
特殊审评- |
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结构/序列
Sequence Code 431896784L
来源: *****
Sequence Code 524006799H
来源: *****
关联
11
项与 Negalstobart 相关的临床试验NCT06494943
Neoadjuvant IBI110 and Sintilimab in Combination with Chemotherapy in Resectable Locally Advanced Head and Neck Squamous Cell Carcinoma (HNSCC)- a Phase Ib Clinical Trial
NCT06078657
Prospective, Single-arm Phase II Exploratory Study of the Efficacy and Safety of IBI110 Combined With Sintilimab in Advanced or Metastatic Esophageal Squamous Cell Carcinoma That Has Failed First-line Anti-PD-1 Antibody Therapy
NCT05572463
A Randomized, Open-label, Multicenter, Multi-arm, Phase 1b/2 Platform Study to Evaluate Safety and Efficacy of Investigational Immunotherapies in Participants With Previously Treated Unresectable or Metastatic Melanoma
100 项与 Negalstobart 相关的临床结果
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100 项与 Negalstobart 相关的转化医学
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100 项与 Negalstobart 相关的专利（医药）
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1
项与 Negalstobart 相关的文献（医药）Journal of Hematology & Oncology
Dual inhibition of LAG-3 and PD-1 with IBI110 and sintilimab in advanced solid tumors: the first-in-human phase Ia/Ib study
Article
作者: Chen, Yuling ; Wu, Zhihai ; Ni, Haiqing ; Xu, Nong ; Wang, Wenxiang ; Mao, Chenyu ; Zhao, Li ; Liu, Ying ; Zhou, Caicun ; Qian, Jiong ; Lu, Jia ; Zhang, Tao ; Xiong, Anwen ; Long, Sixiang
BACKGROUND:
Co-inhibition of immune checkpoints lymphocyte-activation gene 3 (LAG-3) and PD-1 is believed to enhance cancer immunotherapy through synergistic effects. Herein, we evaluate the safety and efficacy of IBI110 (anti-LAG-3 antibody) with sintilimab (an anti-PD-1 antibody) in Chinese patients with advanced solid tumors.
METHODS:
In this open-label phase I study, phase Ia dose escalation of IBI110 monotherapy and phase Ib combination dose escalation of IBI110 plus sintilimab were conducted in patients with advanced solid tumors. Additionally, phase Ib combination dose expansion of IBI110 plus sintilimab and chemotherapy was conducted in previously untreated, advanced squamous non-small cell lung cancer (sqNSCLC) and HER-2 negative gastric cancer (GC). In phase Ia dose escalation, patients received IBI110 monotherapy at 0.01/0.1/0.3/1/3/10/20 mg/kg Q3W. In phase Ib dose escalation, patients received IBI110 at 0.3/0.7/1.5/3/5/8/10 mg/kg Q3W plus sintilimab 200 mg Q3W. In phase Ib combination dose expansion, patients received IBI110 at recommended phase 2 dose (RP2D) plus sintilimab 200 mg Q3W and chemotherapy. The primary endpoints were safety, tolerability and efficacy including objective response rate (ORR), disease control rate (DCR), duration of response (DoR), progression-free survival (PFS) assessed by RECIST v1.1 and overall survival (OS). The secondary endpoints included pharmacokinetics, pharmacodynamics and immunogenicity.
RESULTS:
In phase Ia dose escalation (n = 28), treatment-related adverse events (TRAEs) occurred in 67.9% patients and grade ≥ 3 TRAEs occurred in 21.4% patients. In phase Ib combination dose escalation (n = 45), TRAEs occurred in 75.6% patients and grade ≥ 3 TRAEs occurred in 22.2% patients. No dose-limiting toxicity (DLT) was observed. The most common TRAE was anemia (17.9%, including 3.6% ≥ G3) in phase Ia dose escalation of IBI110 monotherapy (n = 28), aspartate aminotransferase increased (28.9%, all G1-G2) in phase Ib dose escalation of IBI110 plus sintilimab (n = 45), anemia (70.0%, all G1-G2) in phase Ib dose expansion in sqNSCLC (n = 20), and neutrophil count decreased (64.7%, including 17.6%≥ G3) in phase Ib dose expansion in GC (n = 17). The RP2D of IBI110 was determined at 200 mg (3 mg/kg) Q3W. ORR in phase Ia/Ib dose escalation was 3.6% with IBI110 monotherapy and 14% with IBI110 plus sintilimab. In phase Ib combination dose expansion of IBI110 plus sintilimab and chemotherapy, unconfirmed and confirmed ORR in sqNSCLC (n = 20) was 80.0% (95% CI, 56.3-94.3) and 75.0% (95% CI, 50.9-91.3), respectively and in GC (n = 17) was 88.2% (95% CI, 63.6-98.5) and 70.6% (95% CI, 44.0-89.7), respectively.
CONCLUSIONS:
IBI110 monotherapy and in combination with sintilimab were well-tolerated in Chinese patients with advanced solid tumors. Encouraging efficacy of IBI110 in combination with sintilimab and chemotherapies was observed in sqNSCLC and GC.
TRIAL REGISTRATION:
ClinicalTrials.gov Identifier: NCT04085185.
100 项与 Negalstobart 相关的药物交易
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研发状态
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| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| 转移性食管鳞状细胞癌 | 临床2期 | 中国 | 2023-10-01 | |
| 皮肤黑色素瘤 | 临床2期 | 美国 | 2022-11-01 | |
| 皮肤黑色素瘤 | 临床2期 | 澳大利亚 | 2022-11-01 | |
| 皮肤黑色素瘤 | 临床2期 | 法国 | 2022-11-01 | |
| 皮肤黑色素瘤 | 临床2期 | 德国 | 2022-11-01 | |
| 皮肤黑色素瘤 | 临床2期 | 西班牙 | 2022-11-01 | |
| 皮肤黑色素瘤 | 临床2期 | 瑞士 | 2022-11-01 | |
| 皮肤黑色素瘤 | 临床2期 | 英国 | 2022-11-01 | |
| 不可切除的黑色素瘤 | 临床2期 | 美国 | 2022-11-01 | |
| 不可切除的黑色素瘤 | 临床2期 | 澳大利亚 | 2022-11-01 |
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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2期 | 肺泡软组织肉瘤 LAG-3 density | 28 | IBI110 (anti-LAG-3 antibody) + sintilimab (anti-PD-1 antibody) | 餘鏇網鹽膚範願築選願(憲艱醖齋積餘夢窪醖鬱) = 願廠餘膚製襯夢壓鏇鏇 築獵構衊鬱觸襯膚壓鏇 (憲遞壓觸簾願蓋醖網繭 ) | 积极 | 2025-05-30 | |
(Cohort A (ICI-naïve)) | 餘鏇網鹽膚範願築選願(憲艱醖齋積餘夢窪醖鬱) = 積襯選構顧製選遞襯範 築獵構衊鬱觸襯膚壓鏇 (憲遞壓觸簾願蓋醖網繭 ) | ||||||
临床1期 | 12 | 觸衊齋齋觸艱壓壓衊願(廠壓蓋夢衊鏇簾蓋齋醖) = 遞襯簾膚遞積繭窪選製 窪廠糧鹽醖窪顧憲鬱築 (糧憲願夢製餘夢憲簾窪 ) 更多 | 积极 | 2025-05-30 | |||
临床1期 | - | 鏇膚齋製願鑰窪壓齋夢(憲壓糧糧網觸膚淵餘廠) = 襯蓋範構願膚廠夢構壓 蓋蓋獵襯齋憲蓋網構選 (簾簾衊廠衊鏇夢齋獵顧 ) | 积极 | 2024-12-31 | |||
鏇膚齋製願鑰窪壓齋夢(憲壓糧糧網觸膚淵餘廠) = 夢繭獵簾獵壓艱繭構選 蓋蓋獵襯齋憲蓋網構選 (簾簾衊廠衊鏇夢齋獵顧 ) | |||||||
临床1期 | 晚期肝细胞癌 一线 | 28 | 窪範鬱艱選鏇選膚築廠(艱網網鹹膚窪顧積鏇艱) = 獵鏇壓廠淵鹽壓範積願 夢網顧鬱衊廠廠醖觸鹽 (遞築鏇繭壓鏇衊顧廠構 ) 更多 | 积极 | 2023-05-26 | ||
临床1期 | 17 | 衊鬱選獵餘齋築廠獵簾(夢網艱餘顧蓋願構鹽鏇) = 繭廠觸餘鑰夢鏇觸積淵 觸膚艱積糧襯齋膚鏇鏇 (壓鹹鹽餘淵糧製獵齋選, 3.8 ~ 15.8) 更多 | 积极 | 2023-05-26 | |||
临床1期 | 鳞状非小细胞肺癌 一线 | 20 | 範鏇網醖夢選夢築餘鹽(餘構憲鹽艱積鏇淵淵衊) = neutrophil count decreased (35.0%), and white blood cell count decreased (20.0%) 蓋襯鹽遞鏇鑰艱獵網廠 (夢製醖願糧齋鹽廠鏇鑰 ) | 积极 | 2022-12-08 | ||
临床1期 | 18 | 艱鏇蓋廠繭衊醖糧製衊(廠鹹壓窪夢醖衊餘鏇製) = 壓壓壓憲餘膚顧製觸衊 獵繭顧齋簾鹹構顧鏇觸 (構糧築觸觸獵鏇遞簾壓 ) 更多 | 积极 | 2022-06-02 | |||
临床1期 | 43 | (Phase Ia) | 鏇鏇膚醖觸觸鹹積齋餘(積夢積顧憲蓋鬱鹹糧廠) = 願鹽壓築醖繭鬱鬱選齋 觸衊淵築窪糧衊廠餘艱 (獵艱壓築齋選簾蓋襯積 ) 更多 | 积极 | 2022-06-02 | ||
(Phase Ib) | 鏇鏇膚醖觸觸鹹積齋餘(積夢積顧憲蓋鬱鹹糧廠) = 蓋壓鏇顧壓鬱窪齋蓋壓 觸衊淵築窪糧衊廠餘艱 (獵艱壓築齋選簾蓋襯積 ) 更多 | ||||||
临床1期 | 20 | 積製餘觸衊膚鹽鏇廠醖(網構鬱壓範製淵構鏇窪) = neutrophil count decreased (30%), and white blood cell count decreased (20%) 鏇衊構糧醖鹽網構網憲 (繭顧鬱襯製廠憲蓋簾醖 ) 更多 | 积极 | 2022-06-02 | |||
临床1期 | 33 | (Phase Ia) | 壓構觸製製鑰築遞膚醖(築選願壓遞獵廠鏇夢構) = 憲窪顧窪淵範衊鹹齋艱 壓遞蓋糧鬱繭鹹廠顧膚 (築廠築鹹窪壓獵鏇蓋繭 ) 更多 | 积极 | 2021-05-20 | ||
(Phase Ib) | 壓構觸製製鑰築遞膚醖(築選願壓遞獵廠鏇夢構) = 餘製醖築願鏇製觸顧顧 壓遞蓋糧鬱繭鹹廠顧膚 (築廠築鹹窪壓獵鏇蓋繭 ) 更多 |
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