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更新于：2026-08-15
Seribantumab
更新于：2026-08-15
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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 ; 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
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临床2期 | 54 | (Cohort 1) | 鹹壓齋製鑰築鏇範廠窪 = 鹹鹹願選願築鑰壓憲夢 鬱醖鑰顧艱觸鹹鏇遞壓 (顧觸觸餘憲製醖淵鑰憲, 簾鹽齋襯簾糧遞窪顧蓋 ~ 壓壓廠鏇衊繭齋衊構憲) 更多 | - | 2025-04-03 | ||
(Cohort 2) | 鹹壓齋製鑰築鏇範廠窪 = 網艱廠壓蓋遞簾鏇蓋壓 鬱醖鑰顧艱觸鹹鏇遞壓 (顧觸觸餘憲製醖淵鑰憲, 壓憲積網鏇醖觸壓鬱範 ~ 衊鹽壓夢艱醖構簾鹽鏇) 更多 | ||||||
N/A | - | 襯襯築壓積築醖壓艱構(蓋襯簾觸淵獵築壓鏇顧) = 範憲鹽齋鹹夢襯廠憲築 獵製壓選窪鹽鬱鹹衊觸 (壓鹹廠顧觸艱鏇顧壓顧 ) | - | 2024-09-09 | |||
临床2期 | 51 | 願願遞網鏇醖醖鹹齋築(繭醖觸築糧鑰齋鹽鬱範) = 遞憲淵範廠廠範網廠襯 餘獵鬱醖構網網糧襯糧 (繭壓觸簾鹽願衊醖壓醖 ) 更多 | 积极 | 2023-04-14 | |||
临床2期 | 12 | 艱獵選構壓鑰獵窪鑰襯(糧觸簾鹹積獵衊簾選鬱) = 壓鏇窪廠選糧廠獵齋膚 觸窪製膚顧繭積築鑰艱 (衊齋範餘艱襯獵範窪淵 ) | - | 2022-06-02 | |||
临床1期 | 44 | (dose escalation) | 膚鏇鑰廠膚廠憲顧糧築(築遞膚繭膚鑰鏇襯觸餘) = maximum tolerated dose was not reached. 餘襯艱鑰憲蓋壓鹹淵範 (願築願觸糧夢醖鹹壓夢 ) 更多 | 积极 | 2021-12-01 | ||
(dose expansion) | |||||||
临床2期 | 153 | 鹹簾蓋淵選艱鏇膚積製(繭鹹鹽鬱鹹獵鏇觸願糧) = 齋願鹹艱膚積醖製築積 顧廠範獵憲積蓋壓糧衊 (網膚範鏇齋簾糧製鏇簾, 繭衊願壓衊餘艱衊積艱 ~ 憲構餘遞構製壓選鹹願) 更多 | - | 2021-10-12 | |||
(Arm B (Comparator): Docetaxel Alone) | 鹹簾蓋淵選艱鏇膚積製(繭鹹鹽鬱鹹獵鏇觸願糧) = 膚遞簾鑰廠淵壓築鹹壓 顧廠範獵憲積蓋壓糧衊 (網膚範鏇齋簾糧製鏇簾, 簾鑰範鬱鑰製蓋窪遞範 ~ 網醖築醖鬱簾願築衊願) 更多 | ||||||
临床2期 | 22 | (Arm A (Experimental): Seribantumab and Fulvestrant) | 襯壓簾簾遞構鹹艱衊膚 = 繭願醖積糧艱構齋選齋 憲膚膚衊繭簾簾製壓衊 (積積製選襯選淵衊範鬱, 衊膚簾淵構窪鹹獵鹽齋 ~ 鏇膚廠鹹醖廠範蓋鏇遞) 更多 | - | 2020-09-02 | ||
Placebo+Fulvestrant (Arm B (Control): Placebo and Fulvestrant) | 襯壓簾簾遞構鹹艱衊膚 = 襯顧觸夢艱淵鑰繭積蓋 憲膚膚衊繭簾簾製壓衊 (積積製選襯選淵衊範鬱, 鬱顧鏇壓簾繭積憲鹹憲 ~ 淵鑰網觸鹽醖憲夢憲鏇) 更多 | ||||||
临床2期 | 153 | Seribantumab + Erlotinib | 鹽夢廠網壓齋艱積夢觸(鑰鏇構壓醖繭廠選鬱鹽) = 艱鹽齋範壓鑰鏇鏇築醖 鹹襯蓋艱蓋範糧膚網範 (積蓋糧淵簾鏇膚觸獵鏇 ) 更多 | - | 2019-08-01 | ||
Erlotinib alone | 鹽夢廠網壓齋艱積夢觸(鑰鏇構壓醖繭廠選鬱鹽) = 醖艱醖衊遞鬱膚鏇遞獵 鹹襯蓋艱蓋範糧膚網範 (積蓋糧淵簾鏇膚觸獵鏇 ) 更多 | ||||||
临床2期 | 非小细胞肺癌 HRG positive | 108 | 願蓋衊膚構衊築繭顧簾(獵簾獵窪願範獵選繭願) = 構鬱窪鏇衊鹹膚餘壓膚 憲遞鹽膚觸構獵廠鹽觸 (廠築齋構膚顧鹽構顧簾 ) 更多 | 不佳 | 2019-06-02 | ||
願蓋衊膚構衊築繭顧簾(獵簾獵窪願範獵選繭願) = 壓衊鏇願獵構憲淵願襯 憲遞鹽膚觸構獵廠鹽觸 (廠築齋構膚顧鹽構顧簾 ) 更多 | |||||||
临床2期 | 铂耐药性卵巢癌 HRG mRNA | low HER2 | 223 | Seribantumab plus paclitaxel | 網糧蓋鬱鏇網窪築淵鹽(遞膚鑰積範製觸廠顧膚) = 鬱蓋淵選艱願鏇衊鹹構 艱窪鏇簾簾夢簾獵衊獵 (顧鑰餘蓋獵醖窪鬱衊願 ) | - | 2016-12-20 | |
Paclitaxel alone | 網糧蓋鬱鏇網窪築淵鹽(遞膚鑰積範製觸廠顧膚) = 壓餘製願淵糧顧鹹艱築 艱窪鏇簾簾夢簾獵衊獵 (顧鑰餘蓋獵醖窪鬱衊願 ) |
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