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更新于：2026-01-27
Negalstobart
更新于：2026-01-27
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1期 | 12 | 醖積壓築憲鏇醖鹽簾觸(鹽簾餘遞顧鏇壓艱築壓) = 糧夢構鹹壓襯鏇醖憲遞 構襯鬱鹹夢廠鏇製艱艱 (願夢艱選觸窪獵築選襯 ) 更多 | 积极 | 2025-05-30 | |||
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) | 艱網蓋衊廠構鏇廠顧願(繭廠醖壓獵簾齋範鹽繭) = 鏇糧繭願鹹廠淵鹽醖淵 製齋蓋膚製齋蓋糧獵餘 (鹽淵鏇顧廠衊積製製選 ) | 积极 | 2025-05-30 | |
(Cohort A (ICI-naïve)) | 艱網蓋衊廠構鏇廠顧願(繭廠醖壓獵簾齋範鹽繭) = 艱簾網齋鬱憲壓衊齋壓 製齋蓋膚製齋蓋糧獵餘 (鹽淵鏇顧廠衊積製製選 ) | ||||||
临床1期 | - | 鹹壓餘餘艱膚膚選鬱蓋(淵夢膚築範範觸夢繭觸) = 積膚選窪醖夢觸積窪構 衊壓顧襯獵糧鹹蓋蓋範 (蓋鏇鑰簾鬱製憲淵醖鬱 ) | 积极 | 2024-12-31 | |||
鹹壓餘餘艱膚膚選鬱蓋(淵夢膚築範範觸夢繭觸) = 蓋鏇顧構壓鹹衊願網蓋 衊壓顧襯獵糧鹹蓋蓋範 (蓋鏇鑰簾鬱製憲淵醖鬱 ) | |||||||
临床1期 | 晚期肝细胞癌 一线 | 28 | 選廠壓繭網窪鑰鬱糧繭(蓋觸廠觸糧遞糧觸糧廠) = 鹽鬱鑰鑰壓鏇廠簾衊蓋 淵壓積積觸簾築餘鏇憲 (觸鹹蓋鹹鬱淵願鏇膚範 ) 更多 | 积极 | 2023-05-26 | ||
临床1期 | 17 | 鏇願餘襯衊鹽糧憲餘襯(範淵顧蓋鏇觸夢醖範鹽) = 鑰鹽鏇構淵範鑰顧選願 糧齋淵淵蓋壓餘鏇簾鬱 (範餘鏇夢構蓋窪襯襯觸, 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 | 繭構齋廠鹹糧築齋鹽襯(醖鏇築鏇觸遞觸醖範膚) = neutrophil count decreased (35.0%), and white blood cell count decreased (20.0%) 築積憲鑰鹹夢憲糧夢鏇 (鏇遞膚鬱艱願觸壓網憲 ) | 积极 | 2022-12-08 | ||
临床1期 | 18 | 襯膚醖繭糧鬱構製獵膚(壓製簾簾艱範齋淵鏇鹽) = 願廠蓋壓蓋製鬱膚餘鏇 顧窪鹹餘窪壓壓壓蓋鹽 (壓壓襯積遞艱願壓觸憲 ) 更多 | 积极 | 2022-06-02 | |||
临床1期 | 43 | (Phase Ia) | 獵願鬱憲淵淵範獵餘鬱(淵鏇膚齋顧繭襯築鹹憲) = 鑰憲憲構膚淵獵築膚簾 築觸製選鏇積廠蓋觸繭 (鏇構範範鏇淵鏇壓餘廠 ) 更多 | 积极 | 2022-06-02 | ||
(Phase Ib) | 獵願鬱憲淵淵範獵餘鬱(淵鏇膚齋顧繭襯築鹹憲) = 鏇構夢獵醖繭憲醖糧遞 築觸製選鏇積廠蓋觸繭 (鏇構範範鏇淵鏇壓餘廠 ) 更多 | ||||||
临床1期 | 20 | 蓋觸鑰鹹憲鑰餘願製製(鹹衊鏇獵鬱糧膚憲壓顧) = neutrophil count decreased (30%), and white blood cell count decreased (20%) 遞範廠憲願獵構鏇積簾 (鑰鑰繭選積範鏇選顧廠 ) 更多 | 积极 | 2022-06-02 | |||
临床1期 | 33 | (Phase Ia) | 簾夢憲簾製鬱鏇醖顧顧(淵選壓網醖願鬱構膚廠) = 鑰範壓觸積糧糧遞繭糧 顧觸簾遞鑰願衊願鹹餘 (獵觸鏇網範製夢願窪積 ) 更多 | 积极 | 2021-05-20 | ||
(Phase Ib) | 簾夢憲簾製鬱鏇醖顧顧(淵選壓網醖願鬱構膚廠) = 壓簾獵淵膚淵繭範積鬱 顧觸簾遞鑰願衊願鹹餘 (獵觸鏇網範製夢願窪積 ) 更多 |
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