HER2 antagonists(Receptor tyrosine-protein kinase erbB-2 antagonists), ADCC(Antibody-dependent cell-mediated cytotoxicity (ADCC) effects), Immunomodulators

Therapeutic Areas

NeoplasmsDigestive System DisordersSkin and Musculoskeletal Diseases

Active Indication-

Inactive Indication

Advanced HER2-Positive Breast CarcinomaStomach Cancer

Originator Organization

Glycotope GmbH

Active Organization-

Inactive Organization

Glycotope GmbH

License Organization-

Drug Highest PhasePendingPhase 2

First Approval Date-

Regulation-

Structure/Sequence

Sequence Code 18481L

Source: *****

Sequence Code 9500494H

Source: *****

Clinical Trials associated with Timigutuzumab

NCT01409343

/ CompletedPhase 1

A Phase I Dose-Escalation and Pharmacokinetic Study of TrasGEX™ in Patients With Locally Advanced or Metastatic HER-2-positive Cancer

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.

Start Date01 Jul 2011

Sponsor / Collaborator

Glycotope GmbH

[+1]

100 Clinical Results associated with Timigutuzumab

100 Translational Medicine associated with Timigutuzumab

100 Patents (Medical) associated with Timigutuzumab

Literatures (Medical) associated with Timigutuzumab

01 Jan 2018·ESMO openQ3 · MEDICINE

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

Q3 · MEDICINE

ArticleOA

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

PURPOSE:

TrasGEX 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 METHODS:

A 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.

RESULTS:

No 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.

CONCLUSION:

TrasGEX 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).

01 Dec 2015·Journal of clinical pathologyQ3 · MEDICINE

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

Q3 · MEDICINE

Article

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

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.

100 Deals associated with Timigutuzumab

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Stomach Cancer	Phase 2	Germany	Glycotope GmbH	15 Aug 2016
Advanced HER2-Positive Breast Carcinoma	Phase 1	Austria	Glycotope GmbH	01 Jul 2011
Advanced HER2-Positive Breast Carcinoma	Phase 1	Germany	Glycotope GmbH	01 Jul 2011
Advanced HER2-Positive Breast Carcinoma	Phase 1	Italy	Glycotope GmbH	01 Jul 2011
Advanced HER2-Positive Breast Carcinoma	Phase 1	Switzerland	Glycotope GmbH	01 Jul 2011

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT01409343 (Pubmed \| ESMO Open) Manual	Phase 1	HER2 Positive Solid Tumors HER2 Positive	30	Timigutuzumab	tuinptcypn(vqeiebvhat) = cpufkvzjkn gcnrhlhbfu (ybdqggqsqo ) View more	Positive	23 Jun 2018
NCT01409343 (ASCO2014)	Phase 1	HER2 Positive Solid Tumors	37	TrasGEX 12 to 720 mg	cubxulroqc(jkbayuxgkk) = mdgbkyvxga ynmxmzwzvt (kfdgbpjwjr ) View more	-	20 May 2014

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