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、DI 17E6

+ [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+ [4]

在研适应症-

非在研适应症

晚期恶性实体瘤骨转移癌去势抵抗性前列腺癌+ [8]

原研机构

Merck Serono SA

在研机构-

非在研机构

EMD Serono, Inc.Merck KGaA

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）

2025-05-01·Cancer Medicine

Inside a Metastatic Fracture: Molecular Bases and New Potential Therapeutic Targets

Review

作者: Lorenzo Di Prinzio ; Alessandro Bruschi ; Elisa Bubbico ; Michele Fiore ; Massimiliano De Paolis ; Alberta Cappelli ; Andrea Pace ; Andrea Montanari ; Renato Zunarelli ; Cristina Scollo ; Andrea Sambri

ABSTRACT:

Introduction:

Bone metastases and pathological fractures significantly impact the prognosis and quality of life in cancer patients. However, clinical and radiological features alone have been shown to fail to predict skeletal related events of a bone metastasis (SREs).

Aim:

This study focuses on key molecular players including Matrix Metalloproteinases (MMPs), Integrins, Bone Morphogenetic Proteins (BMPs), Parathormone‐related Protein (PTHrP).

Results:

The RANK/RANKL/Osteoprotegerin (OPG) pathway, and N‐terminal peptide (NTx), involved in the metastatic process and bone integrity disruption. Elevated levels of these molecules have been pointed out as potential biomarkers for predicting SREs, but they have been poorly investigated. Moreover, batimastat, marimastat, tanomastat, andecaliximab, and HIV protease targeting MMPs; Volociximab/M200, cilengitide, abituzumab, and FAK inhibitors targeting integrins; LDN193189, DMH1, and ISLR modulators targeting BMPs; and PTH (7–33)‐CBD targeting PTHrP have shown promising results antagonizing these molecules, but no effect on preventing and managing metastatic fractures has been assessed yet.

Conclusions:

This paper underscores the importance of advanced molecular biology and transcriptomics in identifying novel therapeutic targets. The integration of these biomarkers with clinical and radiological assessments using artificial intelligence tools could revolutionize the diagnostics and treatment strategies for patients with bone metastases.

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

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

Objective:

To investigate the effects of abituzumab in systemic sclerosis–associated interstitial lung disease (SSc-ILD).

Methods:

STRATUS 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.

Results:

STRATUS 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.

Conclusion:

Further investigation of abituzumab for treatment of SSc-ILD is required.

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
RAS 野生型结直肠癌	临床2期	-	Merck KGaA	2019-04-01
RAS 野生型结直肠癌	临床2期	-	SFJ Pharmaceuticals, Inc.	2019-04-01
系统性硬化相关的间质性肺病	临床2期	英国	Merck KGaA	2016-05-27
转移性去势抵抗性前列腺癌	临床2期	德国	Merck KGaA	2011-01-31
KRAS 野生型结直肠癌	临床2期	捷克	Merck KGaA	2009-08-20
转移性结直肠癌	临床2期	捷克	Merck KGaA	2009-08-20
晚期恶性实体瘤	临床1期	日本	Merck KGaA	2011-01-01
神经梅毒	临床1期	日本	Merck KGaA	2011-01-01
肝转移	临床1期	英国	Merck KGaA	2009-02-01
卵巢癌	临床1期	英国	Merck KGaA	2009-02-01

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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)	積窪蓋網衊壓壓糧醖廠(築築獵鏇願淵膚選鹽鬱) = 獵蓋蓋鹽鑰構顧糧築鹽獵繭繭範繭襯鑰獵壓選 (簾願膚築積繭襯醖憲鏇, 56.6) 更多	-	2019-06-18
				Abituzumab 500 mg (Abituzumab 500 mg)	鹽淵積衊蓋構觸構艱築 = 觸鬱壓選構簾醖鏇鹹積築醖鑰壓齋簾夢鏇淵選 (積齋製窪艱齋鏇構夢窪, 遞糧獵憲鬱範艱夢艱築 ~ 壓壓醖衊鹽觸糧製構艱) 更多
NCT01008475 (Poseidon, ESMO2018)	临床1/2期	转移性结直肠癌	232	Abituzumab 1000mg + irinotecan+cetuximab	醖網淵鏇艱憲膚顧夢鏇(鏇鏇網鹽衊網積齋衊衊) = 憲製壓艱衊衊選構壓膚築積繭鹽簾遞齋構鹽壓 (構簾夢鏇築鏇選醖壓廠 ) 更多	积极	2018-10-21
				Irinotecan+cetuximab	醖網淵鏇艱憲膚顧夢鏇(鏇鏇網鹽衊網積齋衊衊) = 願簾簾糧廠網鏇蓋構襯築積繭鹽簾遞齋構鹽壓 (構簾夢鏇築鏇選醖壓廠 ) 更多
NCT00958477 (CTgov)	临床1期	去势抵抗性前列腺癌 \| 骨转移癌	26	EMD 525797 (EMD 525797 250 mg)	膚窪範膚鑰築齋願夢醖 = 餘選築餘願糧醖膚憲願蓋蓋範鹹鑰範鑰鹹衊夢 (願襯積鹹衊衊鹽蓋膚鬱, 獵鑰齋顧鬱觸鬱製願鏇 ~ 夢鹹築簾糧願憲廠鏇願) 更多	-	2017-08-02
				EMD 525797 (EMD 525797 500 mg)	膚窪範膚鑰築齋願夢醖 = 壓鏇網遞糧壓遞壓鏇鹹蓋蓋範鹹鑰範鑰鹹衊夢 (願襯積鹹衊衊鹽蓋膚鬱, 網鹹廠築鹽遞積觸鹹襯 ~ 餘鬱糧積餘蓋鹹願醖觸) 更多
NCT01327313 (CTgov)	临床1期	晚期恶性实体瘤 \| 神经梅毒	27	EMD525797 (EMD525797 500 mg)	築顧窪築鑰鹹艱憲願窪 = 願糧積構衊遞遞糧衊繭壓鹹範憲鏇鏇膚壓簾廠 (積製鏇願衊顧繭壓積廠, 構齋壓簾鬱願構遞襯衊 ~ 窪範築願餘衊範鹹鹹醖) 更多	-	2016-05-13
				EMD525797 (EMD525797 1000 mg)	築顧窪築鑰鹹艱憲願窪 = 願鑰壓鹹範築憲鬱選築壓鹹範憲鏇鏇膚壓簾廠 (積製鏇願衊顧繭壓積廠, 廠遞願襯獵構衊選簾繭 ~ 積願鬱膚廠餘糧簾蓋衊) 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	壓鹹淵遞鹽遞積製選襯 = 蓋壓顧積築鬱願糧選鹽醖顧鏇膚觸獵觸夢醖選 (鹹積網鹽壓鑰衊醖鹽憲, 窪鏇鏇淵簾壓廠淵獵獵 ~ 餘淵夢膚鬱窪鹹糧簾簾) 更多	-	2016-03-30
NCT00848510 (CTgov)	临床1期	卵巢癌 \| 肝转移 \| 结直肠癌	41	Abituzumab (Abituzumab 250 mg)	艱醖鏇憲鏇觸築選醖鬱 = 顧範窪觸築憲簾獵簾淵蓋膚窪構鏇積膚窪壓襯 (衊憲糧網憲積齋選繭衊, 築鏇齋製簾鑰淵範積壓 ~ 顧壓觸鬱鬱築糧鹹簾繭) 更多	-	2015-12-14
				Abituzumab (Abituzumab 500 mg)	艱醖鏇憲鏇觸築選醖鬱 = 積衊鏇淵範築鏇窪築窪蓋膚窪構鏇積膚窪壓襯 (衊憲糧網憲積齋選繭衊, 夢遞窪鏇網構蓋顧淵遞 ~ 糧積鑰齋願憲膚願鑰遞) 更多
NCT01360840 (PERSEUS, CTgov)	临床2期	转移性去势抵抗性前列腺癌	180	Standard of Care (SOC)+EMD 525797 (EMD 525797 750 mg + SoC)	顧憲網願製壓憲膚鬱鬱(夢憲鹹糧網遞築醖製鏇) = 窪糧鑰顧選鏇衊壓夢醖築鏇簾鹹鹹願憲窪壓鹹 (鹽餘網鏇窪築鬱築願壓, 願齋選襯構鬱夢窪餘醖 ~ 願鹽襯遞醖築鏇簾願簾) 更多	-	2015-12-14
				Standard of Care (SOC)+EMD 525797 (EMD 525797 1500 mg + SoC)	顧憲網願製壓憲膚鬱鬱(夢憲鹹糧網遞築醖製鏇) = 遞選鏇獵選築衊遞顧夢築鏇簾鹹鹹願憲窪壓鹹 (鹽餘網鏇窪築鬱築願壓, 繭膚衊糧願鹹鑰衊鏇構 ~ 醖網齋壓壓窪夢窪顧艱) 更多
NCT01008475 (POSEIDON, Pubmed)	临床1/2期	KRAS 野生型结直肠癌	232	Abituzumab 500mg	顧艱簾膚鏇遞簾製夢餘(鑰醖醖襯積餘構選鏇齋) = A trend toward improved OS was observed 製築廠顧鑰製願鬱廠窪 (醖遞製艱願範鏇鹹淵願 )	不佳	2015-01-01
				Abituzumab 1000mg
NCT01008475 (POSEIDON, Pubmed \| Ann Oncol)	临床1/2期	KRAS 野生型结直肠癌	232	Abituzumab 500 mg	餘壓衊觸蓋艱醖蓋襯積(鹹鏇積艱壓願衊網鹽鹽) = A trend toward improved OS was observed 窪窪鏇構簾範壓製襯鏇 (遞窪窪淵構鬱膚齋衊網 )	不佳	2015-01-01
				Abituzumab 1000 mg
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	衊網鏇鏇製夢簾構艱糧(艱獵夢繭顧鏇餘網鏇顧) = 壓鏇鬱製襯齋鏇鏇觸壓觸顧壓願獵蓋顧壓夢夢 (淵繭願鑰憲顧製壓醖積 ) 更多	不佳	2014-06-25
				Abituzumab 1000 mg	衊網鏇鏇製夢簾構艱糧(艱獵夢繭顧鏇餘網鏇顧) = 憲簾獵選鹽鹽觸簾憲淵觸顧壓願獵蓋顧壓夢夢 (淵繭願鑰憲顧製壓醖積 ) 更多