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更新于：2026-02-27
Nezutatug
更新于：2026-02-27
概要
基本信息
非在研机构- |
最高研发阶段临床1/2期 |
首次获批日期- |
最高研发阶段(中国)临床申请批准 |
特殊审评- |
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结构/序列
Sequence Code 452860165H
来源: *****
Sequence Code 452860166L
来源: *****
关联
3
项与 Nezutatug 相关的临床试验NCT05910827
A Phase 1b Study to Evaluate HMBD-001 in Combination With Docetaxel With or Without Cetuximab in Participants With Advanced Squamous Non-Small Cell Lung Cancers, and HMBD-001 in Combination With Cetuximab in Participants With Advanced Squamous Cell Cancers
NCT05919537
A Phase 1b Study to Evaluate HMBD-001 With or Without Chemotherapy in Participants With Advanced Solid Tumors Harboring NRG1 Gene Fusions or Selected HER3 Mutations
NCT05057013
A Cancer Research UK Phase I/IIa Open Label, Dose Escalation and Expansion Trial of HMBD-001 (an Anti-HER3 Monoclonal Antibody) Given Intravenously as a Single Agent and in Combination in Patients With Advanced HER3 Positive Solid Tumours
100 项与 Nezutatug 相关的临床结果
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100 项与 Nezutatug 相关的转化医学
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100 项与 Nezutatug 相关的专利（医药）
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2
项与 Nezutatug 相关的文献（医药）2022-09-01Bioanalysis
Development and validation of an ELISA method for quantification of the anti-HER3 antibody HMBD-001 in human serum
Article
作者: Veal, Gareth J ; Idowu, Oladipo S ; Jamieson, David ; Craigen, Jenny L
Background: HMBD-001 is an IgG1 humanized monoclonal antibody specifically targeting HER3, a receptor highly expressed on cancer cells in certain tumors. A bioanalytical method was required to quantify HMBD-001 in human serum, with high selectivity and without interference from HER3. Methods and results: A bridging ELISA using an anti-idiotypic monoclonal capture and detection was developed and validated for quantitative measurement of HMBD-001 in human serum. The assay is sensitive, with a lower limit of quantification of 250 ng/ml, has a broad dynamic range of 250-7000 ng/ml HMBD-001, and exhibits excellent precision and overall accuracy. Conclusion: We have developed and validated a sensitive and selective method for measuring HMBD-001 in human serum. This assay is now being used in a clinical trial setting.
2020-02-01Molecular cancer therapeutics
10D1F, an Anti-HER3 Antibody That Uniquely Blocks the Receptor Heterodimerization Interface, Potently Inhibits Tumor Growth Across a Broad Panel of Tumor Models
Article
作者: Thakkar, Dipti ; Ng, Eric ; Taguiam, Marvin M. ; Sancenon, Vicente ; Wu, Zhihao ; Boyd-Kirkup, Jerome D. ; Paszkiewicz, Konrad H. ; Guan, Siyu ; Ingram, Piers J.
Abstract:
In recent years, HER3 has increasingly been implicated in the progression of a variety of tumor types and in acquired resistance to EGFR and HER2 therapies. Whereas EGFR and HER2 primarily signal through the MAPK pathway, HER3, as a heterodimer with EGFR or HER2, potently activates the PI3K pathway. Despite its critical role, previous attempts to target HER3 with neutralizing antibodies have shown disappointing efficacy in the clinic, most likely due to suboptimal and indirect mechanisms of action that fail to completely block heterodimerization; for example, tumors can escape inhibition of ligand binding by upregulating ligand-independent mechanisms of HER3 activation. We therefore developed 10D1F, a picomolar affinity, highly specific anti-HER3 neutralizing antibody that binds the HER3 heterodimerization interface, a region that was hitherto challenging to raise antibodies against. We demonstrate that 10D1F potently inhibits both EGFR:HER3 and HER2:HER3 heterodimerization to durably suppress activation of the PI3K pathway in a broad panel of tumor models. Even as a monotherapy, 10D1F shows superior inhibition of tumor growth in the same cell lines both in vitro and in mouse xenograft experiments, when compared with other classes of anti-HER3 antibodies. This includes models demonstrating ligand-independent activation of heterodimerization as well as constitutively activating mutations in the MAPK pathway. Possessing favorable pharmacokinetic and toxicologic profiles, 10D1F uniquely represents a new class of anti-HER3 neutralizing antibodies with a novel mechanism of action that offers significant potential for broad clinical benefit.10D1F is a novel anti-HER3 antibody that uniquely binds the receptor dimerization interface to block ligand-dependent and independent heterodimerization with EGFR/HER2 and thus more potently inhibits tumor growth than existing anti-HER3 antibodies.
34
项与 Nezutatug 相关的新闻（医药）2026-02-08
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·医药观澜
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疫苗信使RNA申请上市临床1期核酸药物
100 项与 Nezutatug 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 |
|---|---|---|---|---|
| 晚期食管鳞状细胞癌 | 临床2期 | 澳大利亚 | 2024-02-05 | |
| 晚期食管鳞状细胞癌 | 临床2期 | 摩尔多瓦 | 2024-02-05 | |
| 晚期食管鳞状细胞癌 | 临床2期 | 新加坡 | 2024-02-05 | |
| 晚期食管鳞状细胞癌 | 临床2期 | 韩国 | 2024-02-05 | |
| 晚期食管鳞状细胞癌 | 临床2期 | 中国台湾 | 2024-02-05 | |
| 晚期头颈部鳞状细胞癌 | 临床2期 | 澳大利亚 | 2024-02-05 | |
| 晚期头颈部鳞状细胞癌 | 临床2期 | 摩尔多瓦 | 2024-02-05 | |
| 晚期头颈部鳞状细胞癌 | 临床2期 | 新加坡 | 2024-02-05 | |
| 晚期头颈部鳞状细胞癌 | 临床2期 | 韩国 | 2024-02-05 | |
| 晚期头颈部鳞状细胞癌 | 临床2期 | 中国台湾 | 2024-02-05 |
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临床结果
临床结果
适应症
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临床1/2期 | PIK3CA阳性实体瘤 HER3 positive | 17 | 願構選淵鹹製顧餘蓋鏇(鬱蓋齋膚膚衊鹹夢窪簾) = 網範築壓淵齋糧鹹鑰糧 製糧夢築齋膚鏇艱築廠 (製鏇鬱襯構鹹壓壓艱獵 ) 更多 | 积极 | 2023-10-23 | ||
临床1/2期 | 17 | (150 mg) | 積窪鑰製廠範鬱鬱鏇製(廠衊遞鏇繭網網遞壓壓) = 憲築鑰積願選構鏇廠艱 憲遞膚鑰鑰觸網齋餘蓋 (獵膚夢醖膚獵襯夢壓鹽 ) 更多 | 积极 | 2023-10-23 | ||
(300 mg) | 積窪鑰製廠範鬱鬱鏇製(廠衊遞鏇繭網網遞壓壓) = 膚鹹餘獵鑰遞衊艱鏇壓 憲遞膚鑰鑰觸網齋餘蓋 (獵膚夢醖膚獵襯夢壓鹽 ) 更多 |
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