This was a prospective, open label, multicenter study evaluating the safety, tolerability and pharmacokinetics of TrasGEX™ after intravenous administration in patients with HER-2 positive cancers. The effect of TrasGEX™ on the development of anti-drug antibodies and on tumour response was also evaluated.

开始日期2011-07-01

申办/合作机构

Glycotope GmbH

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100 项与 Timigutuzumab 相关的临床结果

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100 项与 Timigutuzumab 相关的转化医学

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100 项与 Timigutuzumab 相关的专利（医药）

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项与 Timigutuzumab 相关的文献（医药）

2018-01-01·ESMO Open3区 · 医学

Phase I study of TrasGEX, a glyco-optimised anti-HER2 monoclonal antibody, in patients with HER2-positive solid tumours

3区 · 医学

ArticleOA

作者: Baumeister, Hans ; Dietrich, Bruno ; Stoeger, Herbert ; De Dosso, Sara ; Goletz, Steffen ; Weidmann, Jens ; Fiedler, Walter ; Gastl, Guenther ; Perotti, Antonella ; Danielczyk, Antje ; Salzberg, Marc

PURPOSETrasGEX is a second-generation monoclonal antibody of trastuzumab, glyco-optimised to enhance antibody-dependent cellular cytotoxicity while fully retaining trastuzumab's antigen-binding properties to human epidermal growth factor receptor 2 (HER2). A phase I dose-escalation study was conducted to establish the optimal TrasGEX dose and regimen for phase II studies and to define the safety, pharmacokinetics (PK) and preliminary antitumour activity of TrasGEX.PATIENTS AND METHODSA total of 37 patients with advanced HER2-positive carcinomas and progressive disease received TrasGEX intravenously every 3 weeks until disease progression in doses of 12-720 mg in a three-plus-three dose escalation design, including an expansion cohort at the highest dose.RESULTSNo dose limiting toxicity was observed, and no maximum tolerated dose was reached. Drug-related adverse events were mainly infusion-related reactions occurring during the first infusion in 51% of patients; all but two were mild-to-moderate. Compared with trastuzumab, the PK parameters were dose dependent, with a mean terminal half-life (t_1/2) of 263±99 hours for the 720 mg dose. Clinical benefit in 15 out of 30 (50%) evaluable patients included one ongoing complete response, two partial remissions lasting 16 and 77 weeks and disease stabilisation (SD) in 12 patients lasting a median (range) of 17 (7-26) weeks; three of them had SD of 24, 25 and 26 weeks, respectively.CONCLUSIONTrasGEX was safe, well-tolerated and showed antitumour activity in 50% of evaluable patients, all with progressive disease at study entry. Infusions at an interval of 2-3 weeks should achieve clinically relevant trough levels for future studies (NCT01409343).

2015-12-01·Journal of Clinical Pathology3区 · 医学

A glyco-engineered anti-HER2 monoclonal antibody (TrasGEX) induces a long-lasting remission in a patient with HER2 overexpressing metastatic colorectal cancer after failure of all available treatment options

3区 · 医学

Article

作者: Goletz, Steffen ; Eisner, Florian ; Stoeger, Herbert ; Samonigg, Hellmut ; Pichler, Martin

This article discussed about the effect of glyco-engineered anti-HER2 monoclonal antibody (TrasGEX) in a patient with HER2 overexpressing metastatic colorectal cancer after failure of all available treatment options.The author results showed that the patient received 480 mg of TrasGEX i.v. over 4 h and every consecutive cycle on day 21 with an infusion time of 90 min.The results showed that the patient had a decrease of size in lung and liver metastases (sum of the longest diameters, target lesions in the liver and right lower lung lobe reduced from 19.7 to 11.1 cm, target lesion in the right liver lobe from 10 to 5.7 cm) after three cycles.The author concluded that the monoclonal antibody performs in excellent clin. condition with no side effects including cardiotoxicity was occurred.

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研发状态

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适应症	最高研发状态	国家/地区	公司	日期
胃癌	临床2期	德国	Glycotope GmbH	2016-08-15
晚期 HER2 阳性乳腺癌	临床2期	瑞士	Glycotope GmbH	2011-07-01
晚期 HER2 阳性乳腺癌	临床2期	奥地利	Glycotope GmbH	2011-07-01
晚期 HER2 阳性乳腺癌	临床2期	德国	Glycotope GmbH	2011-07-01
晚期 HER2 阳性乳腺癌	临床2期	意大利	Glycotope GmbH	2011-07-01

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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


NCT01409343 (Pubmed \| ESMO Open) 人工标引	临床1期	HER2阳性实体瘤 HER2 Positive	30	Timigutuzumab	(製糧獵蓋簾範願簾選觸) = 鑰觸遞願衊顧淵淵選廠糧鏇鬱鏇衊觸襯餘艱夢 (壓夢醖窪夢願鑰繭壓淵 ) 更多	积极	2018-06-23
NCT01409343 (ASCO2014)	临床1期	HER2阳性实体瘤	37	TrasGEX 12 to 720 mg	(鬱網醖廠窪餘襯製衊簾) = 構齋壓艱選範壓觸鹽餘築鹹遞積簾憲簾齋繭積 (築艱襯鏇顧鏇衊鑰艱鏇 ) 更多	-	2014-05-20