预约演示
更新于：2026-07-15
Seribantumab
更新于：2026-07-15
概要
基本信息
在研机构- |
最高研发阶段终止临床2期 |
首次获批日期- |
最高研发阶段(中国)- |
特殊审评快速通道 (美国) |
登录后查看时间轴
结构/序列
Sequence Code 133293L
来源: *****
Sequence Code 4668179H
来源: *****
关联
17
项与 Seribantumab 相关的临床试验NCT04790695
Single Patient Protocol for an NRG1 Fusion Positive Metastatic Pancreatic Cancer Patient Using Seribantumab
NCT04383210
CRESTONE: A Phase 2 Study of Seribantumab in Adult Patients With Neuregulin-1 (NRG1) Fusion Positive Locally Advanced or Metastatic Solid Tumors
NCT03241810
Randomized Phase 2 Trial of Seribantumab Plus Fulvestrant in Postmenopausal Women With Hormone Receptor-positive, Heregulin Positive (HRG+), HER2 Negative Metastatic Breast Cancer (Merrimack Pharmaceuticals Inc.)
100 项与 Seribantumab 相关的临床结果
登录后查看更多信息
100 项与 Seribantumab 相关的转化医学
登录后查看更多信息
100 项与 Seribantumab 相关的专利（医药）
登录后查看更多信息
27
项与 Seribantumab 相关的文献（医药）2026-04-01Clinical and Molecular Hepatology
ERBB3 blockade sensitizes hepatocellular carcinoma to regorafenib after first-line tyrosine kinase inhibitor resistance by inhibiting HIF1A-ABCB1 signaling
Article
作者: Tao, Baorui ; Yi, Chenhe ; Sun, Rongquan ; Chen, Jinhong ; Lin, Jing ; Geng, Yan ; Zhang, Bo ; Wang, Xiangyu ; Gu, Yinchen
Background/Aims: Regorafenib is recommended by guidelines and trials as a sequential second-line therapy following progression on first-line sorafenib or lenvatinib in hepatocellular carcinoma (HCC). However, efficacy is limited, highlighting the urgent need to screen suitable patients and develop sensitization strategies.Methods: Acquired sorafenib- or lenvatinib-resistant (SR or LR) HCC cell lines and organoids were established. Genome-wide CRISPR library screen was performed in SR or LR cell strains to identify synthetic lethal targets of regorafenib. RNA-seq and FITC-regorafenib efflux assay were used to elucidate ERBB3-driven downstream signaling. Preclinical mouse models of cell line- and patient-derived xenografts and clinical cohorts of HCC patients were employed to validate the efficacy of ERBB3-guided patient stratification.Results: Screening with CRISPR library, we showed that inhibition of ERBB3 was synthetic lethal with regorafenib in SR or LR cell strains and organoids. Mechanistically, SR or LR triggered feedback activation of ERBB3 signaling and mediated regorafenib efflux via ERBB3-HIF1A-ABCB1 cascade pathway, limiting sensitivity to regorafenib. Moreover, ERBB3-low tumors following SR or LR exhibited significant sensitivity to regorafenib, suggesting its potential as a predictive biomarker to screen optimal candidates for sequential therapy. Seribantumab, an ERBB3-targeting monoclonal antibody, inhibited ERBB3-HIF1A-ABCB1 cascade, and its combination with regorafenib exerted marked synergistic anti-tumor effects on ERBB3-high tumors resistant to sorafenib or lenvatinib both in vitro and in vivo.Conclusions: This study revealed that ERBB3 was a key resistance factor driving limited efficacy to sequential regorafenib, but also an effective therapeutic target whose inhibition enhanced regorafenib sensitivity after SR or LR.
2025-08-01JCO Precision Oncology
CRESTONE: A Phase II Study of the Efficacy and Safety of the HER3 Monoclonal Antibody, Seribantumab, in Solid Tumors With Neuregulin-1 (
NRG1
) Fusions
Article
作者: Srivastava, Jaya ; Lin, Jessica J. ; Cheema, Parneet K. ; Patel, Jyoti D. ; Reckamp, Karen L. ; Konduri, Kartik ; Bleeker, Jonathan ; Nguyen, Danny ; Deegan, Maegan ; Weiss, Matthias ; Waqar, Saiama N. ; Ma, Patrick C. ; Burkard, Mark E. ; Misleh, Jamal ; Nagasaka, Misako ; Haura, Eric B. ; Gadgeel, Shirish M. ; Thavaneswaran, Subotheni ; Elamin, Yasir Y. ; Kaufman, Jonathan ; Patil, Tejas ; Schram, Alison M. ; Desai, Jayesh ; Liu, Stephen V. ; Jansen, Valerie M. ; Carrizosa, Daniel R. ; Bauman, Jessica R.
PURPOSE:
Neuregulin-1 (
NRG1
) fusions are rare but actionable oncogenic drivers in solid tumors. Seribantumab is a fully human anti-HER3 IgG2 monoclonal antibody. In this report, we present the antitumor activity and safety data of seribantumab from the CRESTONE study (ClinicalTrials.gov identifier:
NCT04383210
).
PATIENTS AND METHODS:
This was a prospective phase II clinical study in which patients with advanced solid tumors harboring an
NRG1
fusion received seribantumab at a dose of 3,000 mg intravenously once weekly. The primary end point was objective response rate (ORR) by RECIST v1.1. Secondary end points included safety, duration of response, progression-free survival (PFS), overall survival (OS), and disease control rate (DCR). The study was terminated before full enrollment because of sponsor decision, unrelated to safety or efficacy.
RESULTS:
A total of 54 patients with nine different tumor types featuring 19 different
NRG1
fusion partners were enrolled. For the 29 patients included in the primary efficacy analysis, the investigator-assessed ORR was 34.5% (95% CI, 17.9 to 54.3), with a DCR of 79% (95% CI, 60 to 92). The median PFS was 5.4 (95% CI, 3.9 to 10.8) months; the median OS was 20.3 (95% CI, 10.2 to not reached) months. In patients with non–small cell lung cancer, eight of 22 achieved response (ORR, 36.4%). Adverse events (AEs) were mostly grade 1 or 2. The most common treatment-related AEs were diarrhea (39%), fatigue (32%), and nausea (22%).
CONCLUSION:
These results support the antitumor activity and safety of seribantumab in patients with advanced solid tumors harboring
NRG1
fusions.
2024-11-05Circulation
ErbB3 Governs Endothelial Dysfunction in Hypoxia-Induced Pulmonary Hypertension
Article
作者: Junting Zhang ; Yiying Li ; Xiaowei Nie ; Rongchang Chen ; Jingyu Chen ; Yuan Chen ; Lin Deng ; Jin-Song Bian ; Xusheng Yang ; Jianxin Tan
BACKGROUND::
Pulmonary hypertension, characterized by vascular remodeling, currently lacks curative therapeutic options. The dysfunction of pulmonary artery endothelial cells plays a pivotal role in the initiation and progression of pulmonary hypertension (PH). ErbB3 (human epidermal growth factor receptor 3), also recognized as HER3, is a member of the ErbB family of receptor tyrosine kinases.
METHODS::
Microarray, immunofluorescence, and Western blotting analyses were conducted to investigate the pathological role of ErbB3. Blood samples were collected for biomarker examination from healthy donors or patients with hypoxic PH. The pathological functions of ErbB3 were further validated in rodents subjected to chronic hypoxia- and Sugen-induced PH, with or without adeno-associated virus-mediated ErbB3 overexpression, systemic deletion, or endothelial cell–specific ErbB3 knockdown. Primary human pulmonary artery endothelial cells and pulmonary artery smooth muscle cells were used to elucidate the underlying mechanisms.
RESULTS::
ErbB3 exhibited significant upregulation in the serum, lungs, distal pulmonary arteries, and pulmonary artery endothelial cells isolated from patients with PH compared with those from healthy donors. ErbB3 overexpression stimulated hypoxia-induced endothelial cell proliferation, exacerbated pulmonary artery remodeling, elevated systolic pressure in the right ventricle, and promoted right ventricular hypertrophy in murine models of PH. Conversely, systemic deletion or endothelial cell–specific knockout of ErbB3 yielded opposite effects. Coimmunoprecipitation and proteomic analysis identified YB-1 (Y-box binding protein 1) as a downstream target of ErbB3. ErbB3 induced nuclear translocation of YB-1 and subsequently promoted hypoxia-inducible factor 1/2α transcription. A positive loop involving ErbB3-periostin-hypoxia–inducible factor 1/2α was identified to mediate the progressive development of this disease. MM-121, a human anti-ErbB3 monoclonal antibody, exhibited both preventive and therapeutic effects against hypoxia-induced PH.
CONCLUSIONS::
Our study reveals, for the first time, that ErbB3 serves as a novel biomarker and a promising target for the treatment of PH.
100 项与 Seribantumab 相关的药物交易
登录后查看更多信息
外链
| KEGG | Wiki | ATC | Drug Bank |
|---|---|---|---|
| D11777 | Seribantumab | - |
研发状态
10 条进展最快的记录, 后查看更多信息
登录
| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| 胆管癌 | 临床2期 | 美国 | 2020-09-29 | |
| 胆管癌 | 临床2期 | 澳大利亚 | 2020-09-29 | |
| 胆管癌 | 临床2期 | 加拿大 | 2020-09-29 | |
| 胆管癌 | 临床2期 | 韩国 | 2020-09-29 | |
| 膀胱癌 | 临床2期 | 美国 | 2020-09-29 | |
| 膀胱癌 | 临床2期 | 澳大利亚 | 2020-09-29 | |
| 膀胱癌 | 临床2期 | 加拿大 | 2020-09-29 | |
| 膀胱癌 | 临床2期 | 韩国 | 2020-09-29 | |
| 乳腺癌 | 临床2期 | 澳大利亚 | 2020-09-29 | |
| 乳腺癌 | 临床2期 | 韩国 | 2020-09-29 |
登录后查看更多信息
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 | 54 | (Cohort 1) | 顧積願願選餘鬱醖憲醖 = 襯遞衊窪壓餘獵選壓繭 憲鏇築淵構遞鬱觸餘餘 (糧醖鏇蓋鹹鬱襯淵獵願, 憲蓋蓋製齋餘顧鹽糧餘 ~ 齋襯繭構觸構憲鏇廠獵) 更多 | - | 2025-04-03 | ||
(Cohort 2) | 顧積願願選餘鬱醖憲醖 = 鬱淵鬱遞鬱選壓鑰繭襯 憲鏇築淵構遞鬱觸餘餘 (糧醖鏇蓋鹹鬱襯淵獵願, 餘鑰衊製艱衊艱選積積 ~ 觸觸鏇願壓願製範觸選) 更多 | ||||||
N/A | - | 壓醖觸網鑰壓顧繭構繭(襯壓糧選糧網顧鏇憲鬱) = 鹹鑰獵網襯鹽衊構鑰顧 鏇憲顧廠選築齋醖築壓 (獵鏇蓋築獵憲廠襯鹹遞 ) | - | 2024-09-09 | |||
临床2期 | 51 | 鏇夢窪選鹹醖遞簾顧觸(壓壓選構襯淵窪壓襯鏇) = 築獵餘糧襯願簾醖齋製 築鑰蓋壓獵鏇簾鏇壓窪 (糧蓋構顧選簾構獵獵壓 ) 更多 | 积极 | 2023-04-14 | |||
临床2期 | 12 | 醖簾繭構衊遞蓋醖網範(鬱廠鹽鏇窪襯製窪夢憲) = 繭積淵鹹齋鏇壓遞鏇窪 糧艱繭範構觸鑰獵觸選 (鹹鏇獵襯襯艱鹽鏇衊襯 ) | - | 2022-06-02 | |||
临床1期 | 44 | (dose escalation) | 窪選鏇鑰蓋艱衊願壓襯(膚鏇選構構醖齋醖艱鏇) = maximum tolerated dose was not reached. 憲獵廠範觸齋鏇獵淵簾 (築淵網壓鑰鏇構艱簾憲 ) 更多 | 积极 | 2021-12-01 | ||
(dose expansion) | |||||||
临床2期 | 153 | 淵範獵齋餘憲簾網製鏇(衊選選願膚壓襯鏇顧網) = 獵簾窪鏇網廠鹹醖獵餘 淵範鬱鹹鬱簾範艱積遞 (淵選壓艱簾顧醖膚夢憲, 廠範顧鑰積餘醖選繭艱 ~ 網襯衊廠淵憲網製簾淵) 更多 | - | 2021-10-12 | |||
(Arm B (Comparator): Docetaxel Alone) | 淵範獵齋餘憲簾網製鏇(衊選選願膚壓襯鏇顧網) = 餘餘憲窪壓憲製顧鑰夢 淵範鬱鹹鬱簾範艱積遞 (淵選壓艱簾顧醖膚夢憲, 網鏇齋網窪範襯製鹽醖 ~ 衊衊鹽鹹齋積淵獵顧鏇) 更多 | ||||||
临床2期 | 22 | (Arm A (Experimental): Seribantumab and Fulvestrant) | 願糧鹹鹹鏇艱鬱淵網願 = 製願廠艱簾淵蓋蓋廠積 膚鹽範網衊糧繭襯願鹹 (艱選齋襯膚壓襯觸獵網, 艱積鹽鏇壓餘淵憲鹹構 ~ 選蓋築襯製蓋齋夢齋鑰) 更多 | - | 2020-09-02 | ||
Placebo+Fulvestrant (Arm B (Control): Placebo and Fulvestrant) | 願糧鹹鹹鏇艱鬱淵網願 = 膚網願鬱膚鬱鬱糧簾壓 膚鹽範網衊糧繭襯願鹹 (艱選齋襯膚壓襯觸獵網, 醖鹹遞鏇鬱鬱鑰遞觸構 ~ 夢鑰選鹹網遞鹹簾遞顧) 更多 | ||||||
临床2期 | 153 | Seribantumab + Erlotinib | 襯製鏇鏇糧餘選艱醖遞(齋鹽膚餘築積醖顧蓋遞) = 簾淵範壓鹽糧齋廠簾顧 淵願壓繭糧構醖憲築製 (蓋鹹築衊廠積願簾築鑰 ) 更多 | - | 2019-08-01 | ||
Erlotinib alone | 襯製鏇鏇糧餘選艱醖遞(齋鹽膚餘築積醖顧蓋遞) = 艱鹽鏇餘襯糧觸築願鬱 淵願壓繭糧構醖憲築製 (蓋鹹築衊廠積願簾築鑰 ) 更多 | ||||||
临床2期 | 非小细胞肺癌 HRG positive | 108 | 醖窪襯顧獵鬱壓遞夢選(夢衊齋觸鏇鹽網範鑰艱) = 構襯憲鹹繭廠構艱範醖 襯製艱廠糧鑰糧獵鏇簾 (鹹鬱壓遞衊遞壓積齋糧 ) 更多 | 不佳 | 2019-06-02 | ||
醖窪襯顧獵鬱壓遞夢選(夢衊齋觸鏇鹽網範鑰艱) = 獵繭淵蓋製願醖顧網淵 襯製艱廠糧鑰糧獵鏇簾 (鹹鬱壓遞衊遞壓積齋糧 ) 更多 | |||||||
临床2期 | 铂耐药性卵巢癌 HRG mRNA | low HER2 | 223 | Seribantumab plus paclitaxel | 顧糧淵壓壓艱齋鬱壓壓(壓顧鬱網積窪網鹽鑰鏇) = 願積簾積繭憲築蓋範鏇 膚鹹廠範選範憲簾願簾 (壓遞壓蓋鬱選鹹製襯窪 ) | - | 2016-12-20 | |
Paclitaxel alone | 顧糧淵壓壓艱齋鬱壓壓(壓顧鬱網積窪網鹽鑰鏇) = 蓋蓋壓糧觸鹹築鹹遞淵 膚鹹廠範選範憲簾願簾 (壓遞壓蓋鬱選鹹製襯窪 ) |
登录后查看更多信息
转化医学
使用我们的转化医学数据加速您的研究。
登录
或
药物交易
使用我们的药物交易数据加速您的研究。
登录
或
核心专利
使用我们的核心专利数据促进您的研究。
登录
或
临床分析
紧跟全球注册中心的最新临床试验。
登录
或
批准
利用最新的监管批准信息加速您的研究。
登录
或
生物类似药
生物类似药在不同国家/地区的竞争态势。请注意临床1/2期并入临床2期，临床2/3期并入临床3期
登录
或
特殊审评
只需点击几下即可了解关键药物信息。
登录
或
芽仔
全新生物医药AI Agent 覆盖科研全链路，让突破性发现快人一步
立即开始免费试用!
智慧芽新药情报库是智慧芽专为生命科学人士构建的基于AI的创新药情报平台，助您全方位提升您的研发与决策效率。
立即开始数据试用!
智慧芽新药库数据也通过智慧芽数据服务平台，以API或者数据包形式对外开放，助您更加充分利用智慧芽新药情报信息。
生物序列数据库
生物药研发创新
免费使用
化学结构数据库
小分子化药研发创新
免费使用