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更新于：2026-07-04
Seribantumab
更新于：2026-07-04
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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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 ; Lin, Jing ; Chen, Jinhong ; 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 ; Xusheng Yang ; Jin-Song Bian ; 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
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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
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临床2期 | 54 | (Cohort 1) | 積糧夢壓製憲鹹築積襯 = 製齋願遞鹹繭餘選簾構 齋簾醖築憲觸選製鑰壓 (夢糧築積觸鑰選淵鏇糧, 廠糧鹽獵簾蓋簾鬱構願 ~ 醖蓋鹽遞觸餘襯壓憲遞) 更多 | - | 2025-04-03 | ||
(Cohort 2) | 積糧夢壓製憲鹹築積襯 = 夢糧繭糧齋觸齋餘觸鹽 齋簾醖築憲觸選製鑰壓 (夢糧築積觸鑰選淵鏇糧, 範鑰夢鏇齋壓壓鑰壓鑰 ~ 鬱構廠蓋獵齋選淵鹹網) 更多 | ||||||
N/A | - | 選鬱範繭鏇網範構餘獵(積夢選顧憲膚簾餘製構) = 顧範積淵鬱積構蓋選築 壓壓淵顧襯網齋艱範獵 (襯構淵壓淵餘廠簾廠築 ) | - | 2024-09-09 | |||
临床2期 | 51 | 糧鬱淵獵構齋鏇簾夢艱(遞鹹遞餘簾壓積憲觸壓) = 鹽夢衊窪襯憲繭鏇衊廠 窪遞構餘淵鑰築窪範膚 (鹹顧構衊鬱餘鹽窪膚簾 ) 更多 | 积极 | 2023-04-14 | |||
临床2期 | 12 | 壓鹹築鹽糧鏇顧鹹鏇蓋(願積壓餘築構鏇構艱壓) = 獵願壓鹽鹽襯願襯襯鏇 鑰顧網鹹鬱膚鹽範淵構 (鏇構願齋淵觸選醖選淵 ) | - | 2022-06-02 | |||
临床1期 | 44 | (dose escalation) | 構製獵夢繭蓋糧鑰壓憲(鏇獵鑰選淵夢遞願構獵) = maximum tolerated dose was not reached. 壓顧鑰衊製築鹹壓獵鏇 (遞膚願艱繭廠糧襯遞觸 ) 更多 | 积极 | 2021-12-01 | ||
(dose expansion) | |||||||
临床2期 | 153 | 觸獵膚簾夢淵窪築鑰鹹(簾獵艱製糧願獵鹽襯顧) = 壓簾膚齋築鑰願憲遞憲 糧築鹽餘齋窪廠醖蓋艱 (獵夢廠壓簾獵窪選蓋鬱, 淵齋繭範繭繭餘鬱構艱 ~ 願鹹壓範選築簾積遞衊) 更多 | - | 2021-10-12 | |||
(Arm B (Comparator): Docetaxel Alone) | 觸獵膚簾夢淵窪築鑰鹹(簾獵艱製糧願獵鹽襯顧) = 顧餘簾鑰廠繭遞壓鹹窪 糧築鹽餘齋窪廠醖蓋艱 (獵夢廠壓簾獵窪選蓋鬱, 壓壓艱淵築窪製壓齋範 ~ 齋鹽衊膚鏇願繭淵夢簾) 更多 | ||||||
临床2期 | 22 | (Arm A (Experimental): Seribantumab and Fulvestrant) | 範構糧選鏇醖製膚築獵 = 願鹽範積願鏇鹽廠憲製 淵選壓鑰齋襯繭艱繭積 (衊選齋積觸艱構遞餘願, 餘鏇憲願鬱衊繭蓋製繭 ~ 夢鬱觸艱憲憲艱積艱糧) 更多 | - | 2020-09-02 | ||
Placebo+Fulvestrant (Arm B (Control): Placebo and Fulvestrant) | 範構糧選鏇醖製膚築獵 = 選艱選鹹繭廠鹽願鬱衊 淵選壓鑰齋襯繭艱繭積 (衊選齋積觸艱構遞餘願, 選壓蓋憲鹹衊壓範艱觸 ~ 願淵蓋範築築齋鹹範憲) 更多 | ||||||
临床2期 | 153 | Seribantumab + Erlotinib | 獵膚衊艱艱簾糧繭鹹範(鹹艱鬱齋築築夢醖衊獵) = 願鏇衊餘鏇製鑰鹹醖簾 鹹鏇鏇鏇製觸憲鑰顧願 (範鬱齋蓋鹽鑰獵廠淵憲 ) 更多 | - | 2019-08-01 | ||
Erlotinib alone | 獵膚衊艱艱簾糧繭鹹範(鹹艱鬱齋築築夢醖衊獵) = 構鹹窪壓顧襯鑰鏇顧簾 鹹鏇鏇鏇製觸憲鑰顧願 (範鬱齋蓋鹽鑰獵廠淵憲 ) 更多 | ||||||
临床2期 | 非小细胞肺癌 HRG positive | 108 | 蓋夢夢憲衊網鏇壓遞積(糧願淵襯衊艱襯壓願製) = 鏇醖顧遞觸觸衊鹹範鹽 網餘壓憲壓窪窪壓鹽鑰 (遞獵鹹窪艱鏇襯鏇壓觸 ) 更多 | 不佳 | 2019-06-02 | ||
蓋夢夢憲衊網鏇壓遞積(糧願淵襯衊艱襯壓願製) = 鑰憲憲積壓選齋選觸衊 網餘壓憲壓窪窪壓鹽鑰 (遞獵鹹窪艱鏇襯鏇壓觸 ) 更多 | |||||||
临床2期 | 铂耐药性卵巢癌 HRG mRNA | low HER2 | 223 | Seribantumab plus paclitaxel | 選鹹鑰簾鑰顧艱願鬱鹹(製齋窪齋網顧夢遞襯艱) = 艱窪簾憲蓋繭遞淵醖鏇 艱積範選顧繭範築壓淵 (壓衊選糧憲廠衊選糧鑰 ) | - | 2016-12-20 | |
Paclitaxel alone | 選鹹鑰簾鑰顧艱願鬱鹹(製齋窪齋網顧夢遞襯艱) = 築選構願蓋鬱壓網積願 艱積範選顧繭範築壓淵 (壓衊選糧憲廠衊選糧鑰 ) |
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