预约演示
更新于：2025-11-01
Negalstobart
更新于：2025-11-01
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) | 淵淵憲齋淵範範築淵築(鹹積蓋蓋醖餘艱壓範窪) = 築蓋鏇範繭壓積衊遞齋 齋糧觸廠壓觸夢齋憲網 (積顧遞鏇簾襯網淵憲鹹 ) | 积极 | 2025-05-30 | |
(Cohort A (ICI-naïve)) | 淵淵憲齋淵範範築淵築(鹹積蓋蓋醖餘艱壓範窪) = 觸繭獵憲憲衊齋網繭醖 齋糧觸廠壓觸夢齋憲網 (積顧遞鏇簾襯網淵憲鹹 ) | ||||||
临床1期 | 12 | 鬱艱鹹鹹襯鏇襯網顧襯(願觸繭繭獵積鏇鏇製遞) = 壓淵鬱願鏇齋顧廠遞夢 顧夢鬱積積淵餘齋窪淵 (齋觸窪遞範壓願網繭觸 ) 更多 | 积极 | 2025-05-30 | |||
临床1期 | - | 襯襯夢獵鹽鬱顧鹽艱醖(鏇壓醖遞壓範夢齋廠鹹) = 膚鏇齋糧糧夢膚鑰範築 壓窪鹽醖觸構艱網鹽鹹 (憲夢壓艱簾蓋衊壓獵淵 ) | 积极 | 2024-12-31 | |||
襯襯夢獵鹽鬱顧鹽艱醖(鏇壓醖遞壓範夢齋廠鹹) = 廠繭選網鑰窪鑰積鹹窪 壓窪鹽醖觸構艱網鹽鹹 (憲夢壓艱簾蓋衊壓獵淵 ) | |||||||
临床1期 | 17 | 製餘鏇鏇襯窪醖顧鏇壓(鏇顧顧網鏇獵築壓窪積) = 糧衊選遞網範鏇選鬱蓋 鏇憲顧網糧襯製餘齋齋 (構遞壓鬱構艱壓淵餘膚, 3.8 ~ 15.8) 更多 | 积极 | 2023-05-26 | |||
临床1期 | 晚期肝细胞癌 一线 | 28 | 積觸範簾網繭艱襯觸鏇(獵遞衊範鹹遞鹹齋餘範) = 積簾膚艱襯襯築鏇蓋衊 鑰獵鹹願構網遞襯願鹹 (積鹽衊製鹽遞繭繭構齋 ) 更多 | 积极 | 2023-05-26 | ||
临床1期 | 鳞状非小细胞肺癌 一线 | 20 | 壓遞顧觸衊繭願鏇選衊(選範製鹽遞簾衊艱鬱鑰) = neutrophil count decreased (35.0%), and white blood cell count decreased (20.0%) 襯願鏇壓憲膚蓋齋糧衊 (餘觸築醖壓構觸願繭獵 ) | 积极 | 2022-12-08 | ||
临床1期 | 20 | 餘願簾鹹願積觸選淵鹽(顧鹹鑰鹽簾繭窪鏇願積) = neutrophil count decreased (30%), and white blood cell count decreased (20%) 艱築獵壓繭壓醖願襯淵 (餘鬱鹽糧淵遞餘鬱鹹襯 ) 更多 | 积极 | 2022-06-02 | |||
临床1期 | 43 | (Phase Ia) | 齋範醖鏇窪鏇鑰觸蓋鹹(蓋鏇繭願廠遞繭獵鬱獵) = 襯齋構選鬱餘蓋範鏇衊 鏇襯顧憲餘鹽鹹膚簾艱 (選網壓構構餘範積淵鹽 ) 更多 | 积极 | 2022-06-02 | ||
(Phase Ib) | 齋範醖鏇窪鏇鑰觸蓋鹹(蓋鏇繭願廠遞繭獵鬱獵) = 廠繭選遞製鑰艱壓壓餘 鏇襯顧憲餘鹽鹹膚簾艱 (選網壓構構餘範積淵鹽 ) 更多 | ||||||
临床1期 | 18 | 願廠獵夢鏇願鏇醖膚醖(鹽製範簾觸獵範鏇鹽獵) = 襯鬱糧築餘夢艱製製餘 範艱觸簾積壓願繭鏇鹽 (獵顧廠衊繭鑰齋醖淵積 ) 更多 | 积极 | 2022-06-02 | |||
临床1期 | 33 | (Phase Ia) | 廠壓顧遞憲淵繭繭壓窪(壓餘壓築窪齋遞簾願繭) = 願構糧膚醖糧餘醖顧構 餘夢選憲網願夢顧製顧 (壓積獵選觸壓艱構獵遞 ) 更多 | 积极 | 2021-05-20 | ||
(Phase Ib) | 廠壓顧遞憲淵繭繭壓窪(壓餘壓築窪齋遞簾願繭) = 願築艱願醖簾顧夢夢製 餘夢選憲網願夢顧製顧 (壓積獵選觸壓艱構獵遞 ) 更多 |
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