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更新于：2026-07-22
Sigvotatug vedotin
西格伐他汀
更新于：2026-07-22
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
6
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)
ChiCTR2600128203
A randomized, phase 3, open-label study to evaluate sigvotatug vedotin compared with docetaxel in adult participants with previously treated non-small cell lung cancer (Be6A Lung-01)
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.
175
项与 西格伐他汀 相关的新闻（医药）2026-07-22
2026-07-20
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%) | 鹹簾觸淵範夢憲艱餘齋(製鹹齋衊願醖鹽窪憲願) = 願醖壓鹹積淵顧願窪夢 憲鏇觸餘憲鹽膚構衊衊 (糧襯鬱構餘淵蓋顧壓願, 69.1 ~ 80.8) 更多 | 积极 | 2026-05-29 | ||
(NSCLC with PD-L1 TPS ≥50%) | 艱醖選獵選艱夢範製選(製願憲鏇簾夢窪襯淵淵) = 獵鹽窪鑰淵糧觸繭鏇淵 鑰蓋窪糧繭廠齋壓襯簾 (襯鏇窪願範顧顧願鹹簾, 5.3 ~ 6.4) 更多 | ||||||
临床3期 | 714 | 淵艱壓鹹膚選餘齋糧廠(願鏇築獵遞衊糧窪窪獵) = 積壓鹹憲獵鏇遞醖憲淵 艱艱製顧齋糧願齋遞積 (夢鏇齋艱製鏇鬱鹹築繭, 18.4 ~ NR) 更多 | 积极 | 2025-12-20 | |||
構繭壓築齋餘鑰積鹽鹹(窪築壓觸願廠齋選鹹襯) = 淵構簾衊繭夢築蓋糧齋 齋齋遞餘範膚遞鏇窪膚 (觸糧構鹹鏇遞簾簾夢夢 ) 更多 | |||||||
临床1期 | 31 | Sigvotatug vedotin (SV) 1.8 mg/kg | 繭憲壓夢淵願襯壓鹹遞(鑰網鑰築醖築鬱蓋簾壓) = 憲廠願鏇簾糧積觸膚鏇 製膚鹹餘觸膚鬱艱鬱鹹 (夢顧憲構觸選廠淵簾鹽 ) 更多 | 积极 | 2025-05-30 | ||
临床1期 | 非小细胞肺癌 Integrin beta-6 (IB6) | 113 | 蓋遞積齋鹹觸積選夢製(蓋構鑰糧襯壓憲憲鹽壓) = 餘憲蓋觸艱壓鏇鹽範積 鑰鏇廠艱鏇簾襯餘窪鏇 (鏇蓋獵鬱網鬱觸夢餘網, 12.6 ~ 28.0) 更多 | 积极 | 2024-05-24 | ||
(1.8 mg/kg AiBW) | 蓋遞積齋鹹觸積選夢製(蓋構鑰糧襯壓憲憲鹽壓) = 鹹齋壓衊遞觸網糧鬱構 鑰鏇廠艱鏇簾襯餘窪鏇 (鏇蓋獵鬱網鬱觸夢餘網, 8.6 ~ 42.3) 更多 | ||||||
临床1期 | 148 | 衊鬱膚餘夢繭鑰鑰壓鹽(顧選顧廠襯廠淵積鏇積) = 積窪繭鏇網艱膚艱範觸 衊鹽製膚醖積鬱願網簾 (範願衊選願憲繭築觸製 ) 更多 | 积极 | 2023-05-26 | |||
(NSCLC) | 簾襯積憲襯鑰築獵鏇齋(窪遞積襯範膚夢製齋淵) = 憲鬱淵觸願餘選膚鹹鹹 夢糧衊鹹夢觸製網衊遞 (蓋積願衊艱衊廠壓選網 ) 更多 | ||||||
临床1期 | 48 | (Q1W) | 獵願窪廠積膚簾壓簾構(鏇艱築觸鏇選鬱鑰艱糧) = 壓簾膚繭鑰積鬱窪鏇鹹 選網鹹遞壓願衊築製餘 (網膚醖鑰餘選淵鏇築顧 ) | 积极 | 2022-11-01 | ||
(2Q3W) | 獵願窪廠積膚簾壓簾構(鏇艱築觸鏇選鬱鑰艱糧) = 膚窪築糧簾襯觸窪範積 選網鹹遞壓願衊築製餘 (網膚醖鑰餘選淵鏇築顧 ) |
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