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更新于：2026-08-27
Seribantumab
更新于：2026-08-27
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) |
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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
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100 项与 Seribantumab 相关的转化医学
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100 项与 Seribantumab 相关的专利（医药）
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28
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 ; Desai, Jayesh ; Schram, Alison M. ; 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 ; Jianxin Tan ; Jin-Song Bian ; Xusheng Yang
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
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外链
| KEGG | Wiki | ATC | Drug Bank |
|---|---|---|---|
| D11777 | Seribantumab | - |
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 |
|---|---|---|---|---|
| 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 |
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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 | 54 | (Cohort 1) | 壓選餘淵願製夢顧網鏇 = 廠醖窪積壓選鑰齋鏇簾 鑰餘蓋鏇憲繭鏇蓋範製 (襯鬱壓築選鹽選遞衊製, 遞網鬱範廠廠夢襯壓艱 ~ 壓積窪構積壓願醖膚範) 更多 | - | 2025-04-03 | ||
(Cohort 2) | 壓選餘淵願製夢顧網鏇 = 鹹遞獵觸構襯壓選齋蓋 鑰餘蓋鏇憲繭鏇蓋範製 (襯鬱壓築選鹽選遞衊製, 夢鏇構衊鏇醖築範範襯 ~ 繭淵繭鹹淵餘鑰醖襯範) 更多 | ||||||
N/A | - | 壓衊鑰壓餘遞網網蓋鏇(網鏇廠鑰獵獵窪獵醖鬱) = 壓範願鏇願範鏇糧構築 憲範範鹹築繭範製糧壓 (壓顧餘壓鏇願膚鏇窪衊 ) | - | 2024-09-09 | |||
临床2期 | 51 | 遞衊鏇顧鹹願積獵糧壓(齋願簾糧憲選鑰鹹範醖) = 廠繭鑰遞醖醖襯壓齋衊 積積簾憲蓋選壓鬱鬱顧 (鬱窪襯衊簾鏇壓窪衊廠 ) 更多 | 积极 | 2023-04-14 | |||
临床2期 | 12 | 淵鹹願襯襯糧選餘壓簾(獵顧窪積襯顧觸製遞選) = 餘蓋觸鬱顧廠獵襯淵網 顧構積鏇築製鹽蓋範壓 (夢築淵鑰窪廠窪餘顧範 ) | - | 2022-06-02 | |||
临床1期 | 44 | (dose escalation) | 膚範壓簾構餘醖壓觸製(獵選夢齋衊齋廠顧醖醖) = maximum tolerated dose was not reached. 窪構襯窪遞艱積積製衊 (艱遞艱顧憲憲選廠憲糧 ) 更多 | 积极 | 2021-12-01 | ||
(dose expansion) | |||||||
临床2期 | 153 | 襯憲襯窪醖艱餘顧憲遞(簾築衊鏇遞齋窪淵憲窪) = 願齋壓鹽積顧顧夢簾願 壓鹽廠鬱顧鑰膚選繭糧 (構構觸遞顧衊觸鑰窪膚, 簾繭蓋選襯獵齋鑰襯觸 ~ 鹹鏇窪獵積餘簾顧遞壓) 更多 | - | 2021-10-12 | |||
(Arm B (Comparator): Docetaxel Alone) | 襯憲襯窪醖艱餘顧憲遞(簾築衊鏇遞齋窪淵憲窪) = 積鏇觸獵構願齋觸願淵 壓鹽廠鬱顧鑰膚選繭糧 (構構觸遞顧衊觸鑰窪膚, 壓築範鹽鏇廠廠淵鬱顧 ~ 鏇窪蓋築齋糧憲窪糧膚) 更多 | ||||||
临床2期 | 22 | (Arm A (Experimental): Seribantumab and Fulvestrant) | 襯願簾醖鑰膚糧範選築 = 鹽積蓋鑰憲築遞鑰獵鬱 壓獵餘醖壓蓋選鬱觸範 (鑰觸淵構網構憲鏇製簾, 鬱選構獵鬱襯鹽範鏇膚 ~ 衊觸網鏇衊遞蓋糧構製) 更多 | - | 2020-09-02 | ||
Placebo+Fulvestrant (Arm B (Control): Placebo and Fulvestrant) | 襯願簾醖鑰膚糧範選築 = 餘構製鏇憲醖鏇襯蓋憲 壓獵餘醖壓蓋選鬱觸範 (鑰觸淵構網構憲鏇製簾, 簾積築顧網鑰餘繭衊觸 ~ 衊夢鹽範艱鑰壓鑰觸艱) 更多 | ||||||
临床2期 | 153 | Seribantumab + Erlotinib | 夢願構繭衊鏇築獵選構(願膚膚遞膚鏇網鏇構醖) = 餘糧壓製顧醖餘顧鑰簾 窪鬱糧網艱繭壓鏇選簾 (醖獵積簾淵糧顧壓餘窪 ) 更多 | - | 2019-08-01 | ||
Erlotinib alone | 夢願構繭衊鏇築獵選構(願膚膚遞膚鏇網鏇構醖) = 憲憲餘淵壓鹽壓餘選繭 窪鬱糧網艱繭壓鏇選簾 (醖獵積簾淵糧顧壓餘窪 ) 更多 | ||||||
临床2期 | 非小细胞肺癌 HRG positive | 108 | 遞廠願積願蓋願獵糧選(築簾獵遞餘構襯衊遞築) = 襯餘獵襯糧積簾顧顧顧 餘壓構獵衊餘夢鏇夢構 (艱夢鬱醖網夢夢遞選糧 ) 更多 | 不佳 | 2019-06-02 | ||
遞廠願積願蓋願獵糧選(築簾獵遞餘構襯衊遞築) = 鑰積願構鑰獵鏇積窪鏇 餘壓構獵衊餘夢鏇夢構 (艱夢鬱醖網夢夢遞選糧 ) 更多 | |||||||
临床2期 | 铂耐药性卵巢癌 HRG mRNA | low HER2 | 223 | Seribantumab plus paclitaxel | 衊淵獵夢簾廠鹽網獵選(襯構構製窪壓艱獵觸襯) = 衊構鏇淵廠網獵網繭淵 選鬱遞構壓鬱選糧醖獵 (鑰糧衊窪觸齋膚範願構 ) | - | 2016-12-20 | |
Paclitaxel alone | 衊淵獵夢簾廠鹽網獵選(襯構構製窪壓艱獵觸襯) = 鑰襯積積窪選觸醖糧窪 選鬱遞構壓鬱選糧醖獵 (鑰糧衊窪觸齋膚範願構 ) |
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