HER2 Support Group Forums - View Single Post - New bispecific antibody targets her2 and CD3 on Tcells producing effective imm respns

Rich66 · 12-30-2008, 01:47 PM

http://clinicaltrials.gov/ct2/show/N...ns_ex=Y&rank=2

Phase II Study With the Trifunctional Antibody Ertumaxomab to Treat Metastatic Breast Cancer After Progression on Trastuzumab Therapy
This study is currently recruiting participants.
Verified by Fresenius Biotech GmbH, March 2008
Sponsors and Collaborators: Fresenius Biotech GmbH
Fresenius Biotech North America
Information provided by: Fresenius Biotech GmbH ClinicalTrials.gov Identifier: NCT00522457

Purpose This study has the purpose to demonstrate clinical efficacy of the investigational new drug ertumaxomab in patients with HER 2/neu overexpressing (3+ or 2+ with a positive FISH test result) metastatic breast cancer progressing after trastuzumab treatment.
Ertumaxomab is a trifunctional bispecific antibody targeting Her-2/neu on tumor cells and CD3 on T cells. Trifunctional antibodies represent a new concept for targeted anticancer therapy. This new antibody class has the capability to redirect T cells and accessory immune effector cells (e.g. macrophages, dendritic cells [DCs] and natural killer [NK] cells) to the tumor site. According to preclinical data, trifunctional antibodies activate these immune cells, which can trigger a complex anti-tumor immune response.

Condition Intervention Phase Metastatic Breast Cancer
Advanced Breast Cancer
Drug: ertumaxomab
Phase II

Genetics Home Reference related topics: breast cancer
MedlinePlus related topics: Breast Cancer Cancer
Drug Information available for: Immunoglobulins Globulin, Immune Visilizumab Trastuzumab Ertumaxomab
U.S. FDA Resources
Study Type:
Interventional
Study Design:
Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Official Title:
Phase II Study Of The Trifunctional Bispecific Anti-HER-2/Neu x Anti-CD3 Antibody Ertumaxomab In Patients With HER-2/Neu Overexpressing (3+ Or 2+/FISH+) Metastatic Breast Cancer Progressing After Trastuzumab Treatment

Further study details as provided by Fresenius Biotech GmbH:

Primary Outcome Measures: Clinical efficacy measured b

12-30-2008, 01:47 PM	#3
Rich66 Senior Member Join Date: Feb 2008 Location: South East Wisconsin Posts: 3,431	http://clinicaltrials.gov/ct2/show/N...ns_ex=Y&rank=2 Phase II Study With the Trifunctional Antibody Ertumaxomab to Treat Metastatic Breast Cancer After Progression on Trastuzumab Therapy This study is currently recruiting participants. Verified by Fresenius Biotech GmbH, March 2008 Sponsors and Collaborators: Fresenius Biotech GmbH Fresenius Biotech North America Information provided by: Fresenius Biotech GmbH ClinicalTrials.gov Identifier: NCT00522457 Purpose This study has the purpose to demonstrate clinical efficacy of the investigational new drug ertumaxomab in patients with HER 2/neu overexpressing (3+ or 2+ with a positive FISH test result) metastatic breast cancer progressing after trastuzumab treatment. Ertumaxomab is a trifunctional bispecific antibody targeting Her-2/neu on tumor cells and CD3 on T cells. Trifunctional antibodies represent a new concept for targeted anticancer therapy. This new antibody class has the capability to redirect T cells and accessory immune effector cells (e.g. macrophages, dendritic cells [DCs] and natural killer [NK] cells) to the tumor site. According to preclinical data, trifunctional antibodies activate these immune cells, which can trigger a complex anti-tumor immune response. Condition Intervention Phase Metastatic Breast Cancer Advanced Breast Cancer Drug: ertumaxomab Phase II Genetics Home Reference related topics: breast cancer MedlinePlus related topics: Breast Cancer Cancer Drug Information available for: Immunoglobulins Globulin, Immune Visilizumab Trastuzumab Ertumaxomab U.S. FDA Resources Study Type: Interventional Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study Official Title: Phase II Study Of The Trifunctional Bispecific Anti-HER-2/Neu x Anti-CD3 Antibody Ertumaxomab In Patients With HER-2/Neu Overexpressing (3+ Or 2+/FISH+) Metastatic Breast Cancer Progressing After Trastuzumab Treatment Further study details as provided by Fresenius Biotech GmbH: Primary Outcome Measures: Clinical efficacy measured b __________________ Mom's treatment history (link)