90Y Clivatuzumab Tetraxetan(90Y Clivatuzumab Tetraxetan) - 药物靶点：MUC1 x MUC5AC_专利_临床

概要

基本信息

药物类型

抗体偶联核素、治疗用放射药物

别名

90Y-clivatuzumab tetraxetan、Clivatucyn、Clivatuzumab

+ [15]

靶点

MUC1 x MUC5AC

作用方式

抑制剂

作用机制

MUC1抑制剂(黏蛋白-1抑制剂)、MUC5AC抑制剂(粘蛋白-5AC抑制剂)

治疗领域

肿瘤消化系统疾病内分泌与代谢疾病

在研适应症-

非在研适应症

局部晚期胰腺腺癌转移性胰腺癌转移性胰腺腺癌+ [1]

原研机构

Immunomedics, Inc.

在研机构-

非在研机构

New Jersey Medical School

Gilead Sciences, Inc.Garden State Cancer Center

+ [2]

权益机构-

最高研发阶段终止临床3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

使用我们的ADC技术数据为新药研发加速。

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Sequence Code 9723471L

来源: *****

Sequence Code 9723466H

来源: *****

关联

4

项与 90Y Clivatuzumab Tetraxetan 相关的临床试验

NCT01956812

/ Terminated临床3期

An International, Multi-Center, Double-Blind, Randomized, Phase III Trial of 90Y-Clivatuzumab Tetraxetan Plus Low-Dose Gemcitabine Versus Placebo Plus Low-Dose Gemcitabine in Patients With Metastatic (Stage IV) Pancreatic Adenocarcinoma Who Received at Least Two Prior Treatments (PANCRIT-1)

The is a double-blind, randomized phase 3 study of 90Y-clivatuzumab tetraxetan with low-dose gemcitabine, versus placebo and low-dose gemcitabine in metastatic pancreatic cancer patients who have progressed on at least 2 prior therapies for metastatic cancer (1 of which was a gemcitabine-containing regimen).

开始日期2013-12-01

申办/合作机构

Gilead Sciences, Inc.

NCT01510561

/ Withdrawn临床1期

A Ph Ib Study of Fractionated 90Y-hPAM4 Plus Gemcitabine in Pancreatic Cancer Patients Receiving at Least 2 Prior Therapies.

90Y-hPAM4 is administered weekly for 3 weeks combined with 4 weekly doses of gemcitabine to assess. This is a dose escalation study of 90Y-hPAM4 to assess which dose is safe and effective as 3rd line treatment for patients with metastatic pancreatic cancer. Patients are then followed weekly for 12 weeks and afterwards for up to 1 year.

开始日期2012-03-01

申办/合作机构

Gilead Sciences, Inc.

NCT00603863

/ Completed临床1/2期

A Phase Ib/II Study of Fractionated 90Y-hPAM4 Plus Gemcitabine in Patients With Previously Untreated Advanced Pancreatic Cancer.

This is a study to test whether different doses of 90Y-hPAM4 are safe to give in combination with gemcitabine in patients with previously untreated pancreatic cancer.

开始日期2008-01-01

申办/合作机构

Gilead Sciences, Inc.

100 项与 90Y Clivatuzumab Tetraxetan 相关的临床结果

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100 项与 90Y Clivatuzumab Tetraxetan 相关的转化医学

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100 项与 90Y Clivatuzumab Tetraxetan 相关的专利（医药）

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9

项与 90Y Clivatuzumab Tetraxetan 相关的文献（医药）

2015-09-01·European Journal of Cancer1区 · 医学

90 Y-clivatuzumab tetraxetan with or without low-dose gemcitabine: A phase Ib study in patients with metastatic pancreatic cancer after two or more prior therapies

1区 · 医学

Article

作者: Frank, Richard C ; Wegener, William A ; Horne, Heather ; Ocean, Allyson J ; Sharkey, Robert M ; Manzone, Timothy C ; Goldsmith, Stanley J ; Ramanathan, Ramesh K ; Goldenberg, David M ; Richards, Donald A ; Dragovich, Tomislav ; Sheikh, Arif ; Intenzo, Charles M ; Korn, Ronald L ; Picozzi, Vincent J ; Lowery, Maeve A ; Braiteh, Fadi S ; Mitchel, Edith P ; Cohen, Steven J ; Gribbin, Thomas E ; Lee, Marie ; O'Neil, Bert H ; O'Reilly, Eileen M ; Starodub, Alexander N ; Conkling, Paul R ; Pandit-Taskar, Neeta ; Bahary, Nathan ; Bridges, Benjamin B ; Von Hoff, Daniel D ; Lee, Fa-Chyi ; Guarino, Michael J

BACKGROUNDFor patients with metastatic pancreatic adenocarcinoma, there are no approved or established treatments beyond the 2nd line. A Phase Ib study of fractionated radioimmunotherapy was undertaken in this setting, administering (90)Y-clivatuzumab tetraxetan (yttrium-90-radiolabelled humanised antibody targeting pancreatic adenocarcinoma mucin) with or without low radiosensitising doses of gemcitabine.METHODSFifty-eight patients with three (2-7) median prior treatments were treated on Arm A (N=29, (90)Y-clivatuzumab tetraxetan, weekly 6.5 mCi/m(2)doses×3, plus gemcitabine, weekly 200 mg/m(2) doses×4 starting 1 week earlier) or Arm B (N=29, (90)Y-clivatuzumab tetraxetan alone, weekly 6.5 mCi/m(2)doses×3), repeating cycles after 4-week delays. Safety was the primary endpoint; efficacy was also evaluated.RESULTSCytopaenias (predominantly transient thrombocytopenia) were the only significant toxicities. Fifty-three patients (27 Arm A, 26 Arm B, 91% overall) completed ⩾1 full treatment cycles, with 23 (12 Arm A, 11 Arm B; 40%) receiving multiple cycles, including seven (6 Arm A, 1 Arm B; 12%) given 3-9 cycles. Two patients in Arm A had partial responses by RECIST criteria. Kaplan-Meier overall survival (OS) appeared improved in Arm A versus B (hazard ratio [HR] 0.55, 95% CI: 0.29-0.86; P=0.017, log-rank) and the median OS for Arm A versus Arm B increased to 7.9 versus 3.4 months with multiple cycles (HR 0.32, P=0.004), including three patients in Arm A surviving >1 year.CONCLUSIONSClinical studies of (90)Y-clivatuzumab tetraxetan combined with low-dose gemcitabine appear feasible in metastatic pancreatic cancer patients beyond 2nd line and a Phase III trial of this combination is now underway in this setting.

2015-01-02·mAbs2区 · 医学

Antibodies to watch in 2015

2区 · 医学

Review

作者: Reichert, Janice M

The commercial pipeline of recombinant antibody therapeutics is robust and dynamic. As of early December 2014, a total of 6 such products (vedolizumab, siltuximab, ramucirumab, pembrolizumab, nivolumab, blinatumomab) were granted first marketing approvals in 2014. As discussed in this perspective on antibodies in late-stage development, the outlook for additional approvals, potentially still in 2014 and certainly in 2015, is excellent as marketing applications for 7 antibody therapeutics (secukinumab, evolocumab, mepolizumab, dinutuximab, nivolumab, blinatumomab, necitumumab) are undergoing a first regulatory review in the EU or US. Of the 39 novel mAbs currently in Phase 3 studies, a marketing application for one (alirocumab) may be submitted in late 2014, and marketing application submissions for at least 4 (reslizumab, ixekizumab, ocrelizumab, obiltoxaximab) are expected in 2015. Other 'antibodies to watch' are those in Phase 3 studies with estimated primary completion dates in late 2014 or 2015, which includes 13 for non-cancer indications (brodalumab, bimagrumab, bococizumab, MABp1, gevokizumab, dupilumab, sirukumab, sarilumab, tildrakizumab, guselkumab, epratuzumab, combination of actoxumab + bezlotoxumab, romosozumab) and 2 (racotumomab and clivatuzumab tetraxetan) undergoing evaluation as treatments for cancer. In addition to the novel antibody therapeutics mentioned, biosimilar infliximab and biosimilar trastuzumab are 'antibodies to watch' in 2015 because of their potential for entry into the US market and regulatory review, respectively.

2014-07-01·mAbs

Antibodies to watch in 2014

作者: Reichert, Janice M

The commercial pipeline of monoclonal antibodies is highly dynamic, with a multitude of transitions occurring during the year as product candidates advance through the clinical phases and onto the market. The data presented here add to that provided in the extensive "Antibodies to watch in 2014" report published in the January/February 2014 issue of mAbs. Recent phase transition data suggest that 2014 may be a banner year for first approvals of antibody therapeutics. As of May 2014, three products, ramucirumab (Cyramza®), siltuximab (Sylvant®) and vedolizumab (Entyvio™), had been granted first approvals in the United States, and four additional antibody therapeutics (secukinumab, dinutuximab, nivolumab, pembrolizumab) are undergoing regulatory review in either the US or the European Union. Other notable events include the start of first Phase 3 studies for seven antibody therapeutics (dupilumab, SA237, etrolizumab, MPDL3280A, bavituximab, clivatuzumab tetraxetan, blinatumomab). Relevant data for these product candidates are summarized, and metrics for antibody therapeutics development are discussed.

100 项与 90Y Clivatuzumab Tetraxetan 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	90Y Clivatuzumab Tetraxetan	-	DB15368

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
转移性胰腺癌	临床3期	波兰	Gilead Sciences, Inc.	2013-12-01
转移性胰腺癌	临床3期	加拿大	Gilead Sciences, Inc.	2013-12-01
转移性胰腺腺癌	临床3期	奥地利	Gilead Sciences, Inc.	2013-12-01
转移性胰腺腺癌	临床3期	以色列	Gilead Sciences, Inc.	2013-12-01
转移性胰腺腺癌	临床3期	美国	Gilead Sciences, Inc.	2013-12-01
转移性胰腺腺癌	临床3期	法国	Gilead Sciences, Inc.	2013-12-01
转移性胰腺腺癌	临床3期	比利时	Gilead Sciences, Inc.	2013-12-01
转移性胰腺腺癌	临床3期	加拿大	Gilead Sciences, Inc.	2013-12-01
转移性胰腺腺癌	临床3期	西班牙	Gilead Sciences, Inc.	2013-12-01
转移性胰腺腺癌	临床3期	波兰	Gilead Sciences, Inc.	2013-12-01

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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


NCT01956812 (GlobeNewswire) 人工标引	临床3期	胰腺癌	-	Gemcitabine+yttrium-90-labeled (90Y) clivatuzumab tetraxetan	(鏇製艱範廠餘鹽網範衊) = the treatment arm of 90Y-clivatuzumab tetraxetan combined with low-dose gemcitabine and best supportive care did not demonstrate a sufficient improvement in OS as compared to placebo plus low-dose gemcitabine and best supportive care. 醖獵齋齋膚鏇鏇廠構構 (蓋選構製襯壓夢糧願齋 )	不佳	2016-03-14
				Gemcitabine+Placebo
ASCO_GI2012	临床1/2期	胰腺癌一线	100	90Y-hPAM4	(選積淵蓋艱獵鏇網顧壓) = 餘構願鑰顧網鏇壓壓製窪蓋襯製鹹繭顧鹽醖膚 (鑰襯鹹顧壓壓繭鹽夢製 )	-	2012-02-01
ASCO_GI2011	临床1/2期	胰腺癌	42	Clivatuzumab tetraxetan	構選製淵範淵願廠繭築(糧餘顧獵醖膚餘襯鹹鹹) = improved 簾醖築淵遞遞膚艱獵膚 (網範積繭窪積廠廠窪遞 )	-	2011-02-01
				Gemcitabine
ASCO2010	临床1/2期	胰腺癌	-	Clivatuzumab tetraxetan	淵遞窪膚鹽鏇繭衊醖淵(簾鹹鬱鹹醖憲醖鑰憲夢) = 齋遞襯鹽鹽繭醖範窪廠衊蓋網鬱餘鑰願糧艱遞 (蓋製廠鹽膚繭襯願蓋積 ) 更多	-	2010-05-20