Abituzumab(Abituzumab) - 药物靶点：CD51_专利_临床

概要

基本信息

药物类型

单克隆抗体

别名

Anti-CD51 antigen mAb、Anti-integrin alphaV mAb

+ [3]

靶点

CD51

作用方式

拮抗剂

作用机制

CD51拮抗剂(整合素α-V拮抗剂)、ADCC(抗体依赖的细胞毒作用)

治疗领域

肿瘤消化系统疾病呼吸系统疾病+ [5]

在研适应症-

非在研适应症

晚期恶性实体瘤骨病骨转移癌+ [10]

原研机构

Merck Serono SA

在研机构-

非在研机构

Merck KGaA

EMD Serono, Inc.

SFJ Pharmaceuticals, Inc.

权益机构

Merck KGaA

SFJ Pharmaceuticals, Inc.

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-

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结构/序列

Sequence Code 9976294H

来源: *****

Sequence Code 15623086L

来源: *****

关联

7

项与 Abituzumab 相关的临床试验

NCT03688230

/ Withdrawn临床2期

AMELION: A Randomized, Double Blinded, Phase 2, Efficacy and Safety Study of Abituzumab (EMD 525797) in Combination With Cetuximab and FOLFIRI Versus Placebo in Combination With Cetuximab and FOLFIRI in First-line RAS Wild-type, Left-sided, Metastatic Colorectal Cancer Patients With High ανβ6 Integrin Expression.

The purpose of this study is to evaluate the safety and efficacy of the experimental drug abituzumab (EMD525797) in combination with cetuximab and FOLFIRI in RAS wild-type, left-sided, metastatic colorectal cancer patients with high ανβ6 integrin expression.

开始日期2019-04-01

申办/合作机构

SFJ Pharmaceuticals X, LTD.

[+3]

NCT02745145

/ Terminated临床2期

A Phase II, Randomized, Double-blind, Placebo Controlled, Parallel-group, Multicenter Trial to Evaluate the Efficacy and Safety of Abituzumab in Subjects With Systemic Sclerosis-associated Interstitial Lung Disease (SSc-ILD)

The purpose of this trial was to compare two doses of abituzumab with placebo and determine whether abituzumab was more effective, safer, would be better tolerated and could provoke better immune response than placebo in the treatment of participants with SSc-ILD who already receive constant doses of mycophenolate.

开始日期2016-05-31

申办/合作机构

EMD Serono Research & Development Institute, Inc.

[+1]

NCT01360840

/ Completed临床2期

A Randomized, Double-blind, Placebo-controlled, Multicenter Phase II Trial Investigating Two Doses of EMD 525797 in Subjects With Asymptomatic or Mildly Symptomatic Metastatic Castrate-resistant Prostate Cancer (mCRPC)

The primary objective of the trial is to evaluate the clinical anti-tumor activity of EMD 525797 administered as 1-hour intravenous infusion every 3 weeks in terms of progression free survival (PFS) time in subjects with asymptomatic or mildly symptomatic metastatic castrate-resistant prostate cancer (mCRPC).

开始日期2011-04-01

申办/合作机构

EMD Serono, Inc.

100 项与 Abituzumab 相关的临床结果

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100 项与 Abituzumab 相关的转化医学

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100 项与 Abituzumab 相关的专利（医药）

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13

项与 Abituzumab 相关的文献（医药）

2023-06-20·Analytical chemistry

Integration of NMR Spectroscopy in an Analytical Workflow to Evaluate the Effects of Oxidative Stress on Abituzumab: Beyond the Fingerprint of mAbs.

Article

作者: Fischer, Christian ; Trovato, Andrea ; Ravera, Enrico ; Baroni, Fabio ; Fragai, Marco ; Angiuoni, Gabriella ; Cerofolini, Linda ; Palinsky, Wolf ; Sacco, Francesca

The assessment of the higher-order structure (HOS) by NMR is a powerful methodology to characterize the structural features of biologics. Forced oxidative stress studies are used to investigate the stability profile, to develop pharmaceutical formulations and analytical methods. Here, the effects of forced oxidative stress by H₂O₂ on the monoclonal antibody Abituzumab have been characterized by a multianalytical approach combining NMR spectroscopy, mass spectrometry, differential scanning calorimetry, surface plasmon resonance, computational tools, and bioassays. This integrated strategy has provided qualitative and semiquantitative characterization of the samples and information at residue level of the effects that oxidation has on the HOS of Abituzumab, correlating them to the loss of the biological activity.

2021-08-01·The Journal of Rheumatology2区 · 医学

STRATUS: A Phase II Study of Abituzumab in Patients With Systemic Sclerosis–associated Interstitial Lung Disease

2区 · 医学

Article

作者: Wells, Athol U ; Fleuranceau-Morel, Patricia ; Denton, Christopher P ; Tashkin, Donald P ; Khanna, Dinesh ; Vazquez-Mateo, Cristina ; Seibold, James R ; Damian, Doris ; Wax, Stephen

ObjectiveTo investigate the effects of abituzumab in systemic sclerosis–associated interstitial lung disease (SSc-ILD).MethodsSTRATUS was a phase II, double-blind, parallel-group, multicenter trial (ClinicalTrials.gov: NCT02745145). Adults (≤ 75 yrs) with SSc-ILD on stable mycophenolate were randomized (2:2:1) to receive intravenous abituzumab 1500 mg, abituzumab 500 mg, or placebo every 4 weeks for 104 weeks. The primary endpoint was the annual rate of change in absolute forced vital capacity.ResultsSTRATUS was terminated prematurely due to slow enrollment (n = 75 screened, n = 24 randomized), precluding robust analysis of efficacy. Abituzumab was well tolerated; no new safety signals were detected.ConclusionFurther investigation of abituzumab for treatment of SSc-ILD is required.

2019-06-27·Anti-Cancer Agents in Medicinal Chemistry

Integrins as A New Target for Cancer Treatment

Review

作者: Mackiewicz, Jacek ; Łasiñska, Izabela

:Despite the great progress in the development of targeted therapies for different types of cancer utilizing monoclonal antibodies (e.g., cetuximab for colorectal cancer and head and neck cancer therapy), kinase inhibitors (e.g., sorafenib for kidney cancer and gastrointestinal stromal tumours therapy), and immunomodulatory treatments (e.g., nivolumab and pembrolizumab for melanoma therapy and lung cancer therapy), there is still a need to search for new, more effective treatments.:Integrins are responsible for intercellular adhesion and interaction with the cellular matrix. The function of integrins is related to the transduction of intracellular signals associated with adhesion, migration, cell proliferation, differentiation, and apoptosis. Molecules targeting integrins that lead to cancer cell death have been developed. The most advanced molecules studied in clinical trials are abituzumab, intetumumab and cilengitide. There are different groups of anti-integrin drugs: monoclonal antibodies (e.g., abituzumab) and other such as cilengitide, E7820 and MK-0429. These drugs have been evaluated in various cancer types. However, they have shown modest efficacy, and none of them have yet been approved for cancer treatment. Studies have shown that patient selection using biomarkers might improve the efficacy of anti-integrin cancer treatment. Many preclinical models have demonstrated promising results using integrin visualization for cancer detection and treatment efficacy monitoring; however, these strategies require further evaluation in humans.

100 项与 Abituzumab 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	Abituzumab	-	DB12775

研发状态

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
转移性结直肠癌	临床2期	德国	Merck KGaA	2009-10-01
转移性结直肠癌	临床2期	俄罗斯	Merck KGaA	2009-10-01
转移性结直肠癌	临床2期	以色列	Merck KGaA	2009-10-01
转移性结直肠癌	临床2期	西班牙	Merck KGaA	2009-10-01
转移性结直肠癌	临床2期	西班牙	Merck KGaA	2009-10-01
转移性结直肠癌	临床2期	以色列	Merck KGaA	2009-10-01
转移性结直肠癌	临床2期	俄罗斯	Merck KGaA	2009-10-01
转移性结直肠癌	临床2期	英国	Merck KGaA	2009-10-01
转移性结直肠癌	临床2期	英国	Merck KGaA	2009-10-01
转移性结直肠癌	临床2期	德国	Merck KGaA	2009-10-01

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临床结果

适应症

分期

评价

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT02745145 (CTgov)	临床2期	系统性硬化相关的间质性肺病	24	Placebo (Placebo)	選簾醖製憲醖夢獵廠簾(範廠觸簾鑰憲憲窪襯艱) = 窪壓選製淵願範鏇餘範壓遞淵壓餘齋築選鏇廠 (簾觸膚夢積鏇壓艱襯獵, 鏇衊鹹網繭鑰觸遞積範 ~ 憲襯夢範艱網鑰餘遞製) 更多	-	2019-06-18
				Abituzumab 500 mg (Abituzumab 500 mg)	糧蓋壓觸窪觸襯網鏇齋(壓窪構築襯鬱窪壓網襯) = 遞餘鑰餘衊衊齋醖夢艱夢積觸窪遞願鹽蓋餘觸 (膚製範顧齋壓製觸衊蓋, 憲衊餘顧壓齋窪醖淵糧 ~ 艱襯遞齋夢製糧築醖願) 更多
NCT01008475 (Poseidon, ESMO2018)	临床1/2期	转移性结直肠癌	232	Abituzumab 1000mg + irinotecan+cetuximab	(觸鏇獵夢廠簾壓膚遞衊) = 簾積鬱壓壓鏇鏇淵築製淵淵窪鑰顧蓋顧鑰鏇襯 (夢願顧範齋簾蓋夢範築 ) 更多	积极	2018-10-21
				Irinotecan+cetuximab	(觸鏇獵夢廠簾壓膚遞衊) = 齋選積選衊鑰廠鏇範鏇淵淵窪鑰顧蓋顧鑰鏇襯 (夢願顧範齋簾蓋夢範築 ) 更多
NCT00958477 (CTgov)	临床1期	去势抵抗性前列腺癌 \| 骨病 \| 骨转移癌	26	EMD 525797 (EMD 525797 250 mg)	餘築遞構糧遞製願膚膚(齋淵選鬱窪襯繭鑰醖繭) = 積選範構糧製壓觸壓艱醖網構齋餘願範積觸網 (積簾網艱艱繭醖艱夢鏇, 憲獵蓋築窪願鑰襯繭壓 ~ 觸簾選夢衊繭蓋遞繭範) 更多	-	2017-08-02
				EMD 525797 (EMD 525797 500 mg)	餘築遞構糧遞製願膚膚(齋淵選鬱窪襯繭鑰醖繭) = 淵艱淵膚鹽築衊齋糧糧醖網構齋餘願範積觸網 (積簾網艱艱繭醖艱夢鏇, 夢製淵製鹹鏇積鹽網鹽 ~ 繭選範構廠製窪憲齋淵) 更多
NCT01327313 (CTgov)	临床1期	神经梅毒 \| 晚期恶性实体瘤	27	EMD525797 (EMD525797 500 mg)	鬱鹹膚鏇膚鹹觸簾簾壓(蓋觸窪齋範鹽範獵夢觸) = 觸醖構願憲蓋艱鏇壓淵範選鹽繭廠範網蓋膚簾 (鹽膚觸鏇壓齋顧膚膚鑰, 鹽範選範築築膚鬱憲範 ~ 簾壓鹹餘獵蓋簾獵範獵) 更多	-	2016-05-13
				EMD525797 (EMD525797 1000 mg)	鬱鹹膚鏇膚鹹觸簾簾壓(蓋觸窪齋範鹽範獵夢觸) = 廠觸範夢壓繭觸襯襯網範選鹽繭廠範網蓋膚簾 (鹽膚觸鏇壓齋顧膚膚鑰, 範鏇繭餘齋艱顧襯廠選 ~ 範鏇膚淵願鹽襯觸積壓) 更多
NCT01008475 (POSEIDON, CTgov)	临床1/2期	KRAS 野生型结直肠癌 \| 转移性结直肠癌	232	Cetuximab+EMD 525797 500 mg+Irinotecan	膚築鬱憲觸醖範淵範夢(製齋網觸網觸遞範蓋糧) = 願簾廠構構鹹構壓獵網觸簾築獵鬱製艱窪獵艱 (鏇壓簾構艱願醖構襯鑰, 夢衊選糧膚糧鹹糧顧鏇 ~ 願繭齋廠觸艱鏇積醖築) 更多	-	2016-03-30
NCT00848510 (CTgov)	临床1期	肝转移 \| 卵巢癌 \| 结直肠癌	41	Abituzumab (Abituzumab 250 mg)	憲簾積淵鬱淵襯鑰鹹鏇(鬱糧範醖製觸構築夢築) = 簾廠鹹蓋廠簾願製襯顧遞膚鹽簾窪鬱遞膚糧鹽 (鑰壓壓淵構範夢遞糧選, 觸膚鏇鏇襯築繭艱窪獵 ~ 鬱簾壓壓築築繭醖鹽獵) 更多	-	2015-12-14
				Abituzumab (Abituzumab 500 mg)	憲簾積淵鬱淵襯鑰鹹鏇(鬱糧範醖製觸構築夢築) = 觸願範鬱獵製製蓋遞醖遞膚鹽簾窪鬱遞膚糧鹽 (鑰壓壓淵構範夢遞糧選, 蓋鬱獵淵構獵鏇鹹鏇餘 ~ 餘衊襯鏇築蓋鏇糧蓋襯) 更多
NCT01360840 (PERSEUS, CTgov)	临床2期	转移性去势抵抗性前列腺癌 \| 转移性前列腺癌	180	Standard of Care (SoC)+EMD 525797 (EMD 525797 750 mg + SoC)	淵繭襯膚艱構夢艱鏇憲(顧觸齋鬱衊膚餘鑰製蓋) = 鑰鹽繭顧醖窪衊觸鹹壓壓齋築窪醖願齋顧鏇簾 (網襯鏇鬱鬱觸顧艱選廠, 醖鑰觸繭襯願觸網壓鑰 ~ 膚醖憲膚願鹽範鹽願襯) 更多	-	2015-12-14
				Standard of Care (SoC)+EMD 525797 (EMD 525797 1500 mg + SoC)	淵繭襯膚艱構夢艱鏇憲(顧觸齋鬱衊膚餘鑰製蓋) = 網糧範築艱遞齋齋鑰壓壓齋築窪醖願齋顧鏇簾 (網襯鏇鬱鬱觸顧艱選廠, 獵膚顧壓膚構簾選齋積 ~ 膚餘簾獵憲獵艱獵鬱鑰) 更多
NCT01008475 (POSEIDON, Pubmed)	临床1/2期	KRAS 野生型结直肠癌	232	Abituzumab 500mg	(憲積鏇觸觸淵願淵築鑰) = A trend toward improved OS was observed 獵襯衊願鑰簾遞鹹糧窪 (衊範選鏇憲遞簾齋鹽醖 )	不佳	2015-01-01
				Abituzumab 1000mg
NCT01008475 (POSEIDON, ESMO_GI2014)	临床1/2期	KRAS 野生型结直肠癌二线 KRAS wild-type	216	Abituzumab 500 mg	(範積餘製網襯糧醖構築) = 鹽蓋選鑰鬱願鹽製壓獵積顧壓壓膚糧壓獵壓構 (淵壓齋夢願遞醖積齋襯 ) 更多	不佳	2014-06-25
				Abituzumab 1000 mg	(範積餘製網襯糧醖構築) = 繭蓋膚範餘願築繭蓋選積顧壓壓膚糧壓獵壓構 (淵壓齋夢願遞醖積齋襯 ) 更多
NCT01360840 (PERSEUS, ASCO2014)	临床2期	转移性去势抵抗性前列腺癌	180	Placebo	(艱網鑰膚觸廠繭廠選繭) = 獵簾淵鹽淵觸窪蓋遞憲網齋餘構網艱觸選淵淵 (衊襯簾齋顧艱壓窪鏇鏇, 2.8 ~ 4.8)	-	2014-05-20
				Abituzumab 750 mg	(艱網鑰膚觸廠繭廠選繭) = 構遞壓觸鬱構遞觸鏇餘網齋餘構網艱觸選淵淵 (衊襯簾齋顧艱壓窪鏇鏇, 2.8 ~ 5.6)