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更新于：2026-07-15
Sigvotatug vedotin
西格伐他汀
更新于：2026-07-15
概要
基本信息
药物类型 ADC |
别名 humanized immunoglobulin G1 anti-integrin beta-6 monoclonal antibody conjugated to monomethyl auristatin E、SV、PF 06445749 + [7] |
作用方式 抑制剂 |
作用机制 ITGB6抑制剂(integrin subunit beta 6 inhibitors)、微管蛋白抑制剂 |
在研适应症 |
非在研适应症- |
原研机构 |
在研机构 |
非在研机构- |
权益机构- |
最高研发阶段临床3期 |
首次获批日期- |
最高研发阶段(中国)临床3期 |
特殊审评孤儿药 (美国) |
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结构/序列
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Sequence Code 719985308H
来源: *****
Sequence Code 719985316L
来源: *****
关联
5
项与 西格伐他汀 相关的临床试验NCT07227298
AN INTERVENTIONAL OPEN-LABEL PHASE 1B/2 STUDY TO EVALUATE THE SAFETY, PHARMACOKINETICS, AND PRELIMINARY EFFICACY OF PF-08634404 IN COMBINATION WITH DIFFERENT ANTICANCER AGENTS IN PARTICIPANTS WITH ADVANCED SOLID TUMORS
NCT06758401
AN OPEN-LABEL, RANDOMIZED, CONTROLLED PHASE 3 STUDY OF SIGVOTATUG VEDOTIN IN COMBINATION WITH PEMBROLIZUMAB COMPARED WITH PEMBROLIZUMAB MONOTHERAPY AS FIRST-LINE TREATMENT IN PARTICIPANTS WITH PD-L1 HIGH (≥50% OF TUMOR CELLS EXPRESSING PD-L1), LOCALLY ADVANCED, UNRESECTABLE, OR METASTATIC NON-SMALL CELL LUNG CANCER (BE6A LUNG-02)
NCT06549816
An Open-label, Phase 1 Study to Investigate the Safety and Pharmacokinetics of SGN-B6A in Chinese Subjects With Advanced Solid Tumors
100 项与 西格伐他汀 相关的临床结果
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100 项与 西格伐他汀 相关的转化医学
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100 项与 西格伐他汀 相关的专利（医药）
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543
项与 西格伐他汀 相关的文献（医药）2026-06-10JOURNAL OF CLINICAL ONCOLOGY
First-in-Human, Phase I Study of Sigvotatug Vedotin, an Integrin Beta-6–Directed Antibody-Drug Conjugate: Results From Dose Expansion in Advanced Non–Small Cell Lung Cancer
Article
作者: Bockorny, Bruno ; Hollebecque, Antoine ; Galvao, Vladimir ; Piha-Paul, Sarina A. ; Hernandez-Guerrero, Tatiana ; Patilea-Vrana, Gabriela ; Lopez, Juanita S. ; Wang, Tianhua ; Dowlati, Afshin ; Patnaik, Amita ; Kingsley, Edwin ; Knowles, Scott ; Sehgal, Kartik ; Wang, Yimo ; Rivera Herrero, Fernando ; Peters, Solange ; Perez, Cesar Augusto ; Fontana, Elisa ; Sanborn, Rachel E. ; Li, Jerry ; Calvo, Emiliano
PURPOSE:
Integrin beta-6 (IB6) is highly expressed in non–small cell lung cancer (NSCLC) and other solid tumors and potentially associated with poor outcomes. Sigvotatug vedotin (SV), a novel IB6-directed antibody-drug conjugate, demonstrated acceptable safety and encouraging antitumor activity in dose escalation. We report updated results for dose-expansion regimens in advanced NSCLC (aNSCLC).
METHODS:
SGNB6A-001 is an open-label, multicenter, dose-escalation/dose-expansion phase I study evaluating safety, tolerability, pharmacokinetics (PK), and antitumor activity of SV in patients with select advanced solid tumors. After dose escalation, dose expansion further explored three regimens: 1.25 mg/kg total body weight (TBW) on Days 1 and 8 of a 21-day cycle, 1.5 mg/kg TBW on Days 1 and 15 of a 28-day cycle (once every 2 weeks), and 1.8 mg/kg adjusted ideal body weight (AiBW) once every 2 weeks. Eligible patients had prior chemotherapy and immunotherapy or targeted therapy if indicated. Primary end points were safety and determination of an optimal dosing schedule. Secondary end points were antitumor activity, PK, and immunogenicity.
RESULTS:
As of November 26, 2024, 117 patients with aNSCLC were treated in the above cohorts. Any-grade and grade ≥3 treatment-emergent adverse events occurred in 98% and 48% of all patients, respectively, and in 94% and 35% of patients receiving SV 1.8 mg/kg AiBW once every 2 weeks. Modeling revealed that the AiBW regimen resulted in lower PK variability than TBW regimens. The objective response rate and median duration of response were 19% and 11.3 months in the overall population, respectively, and 29% and 12.8 months in patients with nonsquamous, taxane-naïve NSCLC.
CONCLUSION:
SV demonstrated a manageable safety profile and promising antitumor activity with durable responses in aNSCLC. PK and clinical data support further investigation with the recommended 1.8-mg/kg AiBW once every 2 weeks dosing regimen.
2026-06-01CANCER
Mapping the antibody–drug‐conjugates landscape in non–small cell lung cancer: Where are we and where are we going?
Review
作者: Parisi, Claudia ; Planchard, David ; Barlesi, Fabrice
Abstract:
Antibody–drug conjugates (ADCs) represent a rapidly advancing therapeutic class in the treatment of non‐small cell lung cancer (NSCLC), offering targeted delivery of cytotoxic agents to tumor cells while minimizing off‐target toxicity. In recent years, several ADCs have emerged in both early (phase 1–2) and late (phase 3) clinical development, reflecting a growing recognition of their potential to improve outcomes in defined subsets of patients with advanced NSCLC. Late‐phase ADCs include trastuzumab deruxtecan (targeting HER2 [human epidermal growth factor receptor 2]), datopotamab deruxtecan and sacituzumab govitecan (targeting TROP2 [trophoblast cell‐surface antigen 2]), patritumab deruxtecan (targeting HER3), telisotuzumab vedotin (targeting c‐MET [cellular‐mesenchymal epithelial transition factor]), and sigvotatug vedotin (targeting IB6 [integrin beta‐6]). Research efforts are ongoing to explore novel payloads, linker technologies, and targets to expand the applicability of ADCs across broader NSCLC populations, including those with limited treatment options (e.g.,
EGFR
‐mutant disease in the context of treatment resistance). Despite their promise, challenges remain in optimizing patient selection, overcoming resistance mechanisms, and managing unique toxicity profiles. Ongoing, biomarker‐driven trials and combination strategies with immunotherapy or tyrosine kinase inhibitors hold the potential to further enhance the efficacy of ADCs. In this review, the authors highlight the current landscape and future directions of ADCs in NSCLC, emphasizing available results for compounds in late‐stage clinical development and different disease settings.
2026-05-01CANCER TREATMENT REVIEWS
Integrin beta-6: Its emerging role as a therapeutic target in solid tumors
Review
作者: Barbie, David ; Peters, Solange ; Sanborn, Rachel E
Integrins, a family of heterodimeric transmembrane receptors, mediate bidirectional intercellular communication as well as cellular communication with the extracellular matrix. Integrin beta-6 (IB6), which is formed via exclusive dimerization of the β6 subunit with the αv subunit, is expressed at low levels in healthy epithelial tissues and upregulated during the epithelial remodeling associated with development and wound healing. The role of IB6 in these processes is thought to be exploited during tumorigenesis enabling migration, invasion, proliferation, and survival. In fact, IB6 expression has been reported in numerous solid tumors, particularly at the invasive edge, and IB6 represents a promising anticancer therapeutic target. Over the last two decades, there have been several distinct strategies targeting IB6 investigated in preclinical studies. While many of the early preclinical strategies were discontinued after disappointing results in initial clinical studies, using IB6 as a target for antibody-drug conjugates has shown promise in early trials. Sigvotatug vedotin, an IB6-directed antibody-drug conjugate linked to a monomethyl auristatin E payload showed promising efficacy in a phase 1 study in patients with advanced solid tumors, particularly non-small cell lung cancer, and is being investigated in two phase 3 studies. Additionally, several other IB6-directed antibody-drug conjugates have demonstrated antitumor activity in preclinical studies and are entering the clinical stage of development. Results from these studies will enable greater understanding of IB6 as an anticancer therapeutic target, as well as IB6 expression as a potential biomarker.
100 项与 西格伐他汀 相关的药物交易
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研发状态
10 条进展最快的记录, 后查看更多信息
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| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| 局部晚期非小细胞肺癌 | 临床3期 | 美国 | 2025-07-23 | |
| 局部晚期非小细胞肺癌 | 临床3期 | 中国 | 2025-07-23 | |
| 局部晚期非小细胞肺癌 | 临床3期 | 日本 | 2025-07-23 | |
| 局部晚期非小细胞肺癌 | 临床3期 | 阿根廷 | 2025-07-23 | |
| 局部晚期非小细胞肺癌 | 临床3期 | 澳大利亚 | 2025-07-23 | |
| 局部晚期非小细胞肺癌 | 临床3期 | 奥地利 | 2025-07-23 | |
| 局部晚期非小细胞肺癌 | 临床3期 | 比利时 | 2025-07-23 | |
| 局部晚期非小细胞肺癌 | 临床3期 | 巴西 | 2025-07-23 | |
| 局部晚期非小细胞肺癌 | 临床3期 | 保加利亚 | 2025-07-23 | |
| 局部晚期非小细胞肺癌 | 临床3期 | 加拿大 | 2025-07-23 |
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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3期 | 714 | (NSCLC with PD-L1 TPS ≥50%) | 膚憲糧醖糧鑰鹽廠憲鹹(醖夢築築糧鑰齋鑰簾鬱) = 遞築鏇糧鏇廠選艱鹹積 淵繭構淵蓋獵蓋簾鬱廠 (網網繭蓋顧餘構衊憲齋, 69.1 ~ 80.8) 更多 | 积极 | 2026-05-29 | ||
(NSCLC with PD-L1 TPS ≥50%) | 壓網築膚蓋簾構鹹淵鏇(繭積餘構壓糧簾觸構鏇) = 淵艱願觸製襯鏇鬱壓鑰 壓構艱鏇鑰鑰選憲鏇壓 (鬱網夢衊繭壓鑰齋顧積, 5.3 ~ 6.4) 更多 | ||||||
临床3期 | 714 | 遞簾鏇製膚積衊簾構築(鹹鑰製網遞糧齋艱淵繭) = 願選簾壓鹹壓簾遞窪構 醖鹽醖窪選獵遞願襯夢 (鹹範獵膚憲餘膚蓋選餘, 18.4 ~ NR) 更多 | 积极 | 2025-12-20 | |||
鹹觸網夢蓋鹹網繭膚齋(夢簾觸鑰襯鹹顧鹽壓願) = 糧鹽鑰膚遞膚繭醖膚艱 廠鏇壓構蓋淵淵築衊鑰 (夢積壓顧願繭觸壓餘夢 ) 更多 | |||||||
临床1期 | 31 | Sigvotatug vedotin (SV) 1.8 mg/kg | 鹽壓顧積獵選夢鹽積夢(鑰廠襯糧膚鏇衊製遞獵) = 淵餘壓願積艱鏇憲壓鑰 獵憲艱願衊顧鏇膚積簾 (糧膚憲淵蓋顧鬱鹽鑰鏇 ) 更多 | 积极 | 2025-05-30 | ||
临床1期 | 非小细胞肺癌 Integrin beta-6 (IB6) | 113 | 淵構襯齋膚膚簾憲齋窪(齋願鹹膚艱鹹醖鬱鏇顧) = 衊廠淵鏇積築鹽鹹繭製 醖遞蓋鹹衊顧廠簾膚遞 (簾築糧餘選獵醖範願餘, 12.6 ~ 28.0) 更多 | 积极 | 2024-05-24 | ||
(1.8 mg/kg AiBW) | 淵構襯齋膚膚簾憲齋窪(齋願鹹膚艱鹹醖鬱鏇顧) = 艱繭餘夢廠鹹醖壓衊壓 醖遞蓋鹹衊顧廠簾膚遞 (簾築糧餘選獵醖範願餘, 8.6 ~ 42.3) 更多 | ||||||
临床1期 | 148 | 艱遞夢積醖簾醖觸鬱願(淵遞齋夢網餘淵鏇觸顧) = 淵積鑰夢鏇選窪糧獵築 選製蓋範淵繭遞範廠醖 (夢衊獵膚餘艱選齋鹹鏇 ) 更多 | 积极 | 2023-05-26 | |||
(NSCLC) | 襯夢淵築獵醖繭鬱繭鹹(膚憲鹹膚觸鬱糧夢獵遞) = 餘積選網鏇選廠顧鹽餘 襯築鹹壓選膚觸積窪餘 (鏇築遞壓鹹顧範餘鹹製 ) 更多 | ||||||
临床1期 | 48 | (Q1W) | 鏇鏇鏇鑰窪糧鹽繭窪襯(製鏇艱鹹築窪鏇鏇鑰積) = 顧獵襯鹽選膚鹽繭齋鑰 衊齋餘積積壓蓋簾餘鏇 (願鹽淵鏇窪築廠鑰範艱 ) | 积极 | 2022-11-01 | ||
(2Q3W) | 鏇鏇鏇鑰窪糧鹽繭窪襯(製鏇艱鹹築窪鏇鏇鑰積) = 壓壓淵獵願鹽艱鬱鑰壓 衊齋餘積積壓蓋簾餘鏇 (願鹽淵鏇窪築廠鑰範艱 ) |
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