Ignite Creation Date:
2024-05-05 @ 5:26 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00452140
Status:
TERMINATED
Last Update Posted:
2009-05-19
First Post:
2007-03-26
Brief Title:
Phase II Study With the Trifunctional Antibody Ertumaxomab to Treat Metastatic Breast Cancer Progressing After Endocrine Treatment
Sponsor:
Neovii Biotech
Organization:
Neovii Biotech
Study Overview
Official Title:
Phase II Study for Repeated Dosing of the Trifunctional Bispecific Anti-HER-2Neu x Anti-CD3 Antibody Ertumaxomab in Patients With HER-2Neu 1 or 2FISH Negative Expressing Advanced or Metastatic Breast Cancer Stage IIIbIV Progressing After Endocrine Treatment
Status:
TERMINATED
Status Verified Date:
2009-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
company focus on other projects
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of the study is to demonstrate clinical efficacy of the investigational trifunctional bispecific antibody ertumaxomab for treatment of patients with HER-2neu 1 or 2 FISH- expressing advanced or metastatic breast cancer stage III bIV which has progressed after endocrine therapy
Ertumaxomab is a trifunctional bispecific antibody targeting Her-2neu 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 cells eg 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
Ertumaxomab is a trifunctional bispecific antibody targeting Her-2neu 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 cells eg 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
Detailed Description:
An open-label non-randomized uncontrolled one-stage phase II study evaluating the efficacy and safety of the investigational trifunctional bispecific antibody ertumaxomab anti-Her-2neu x anti-CD3 for the treatment of hormone therapy refractory advanced or metastatic breast cancer tumours stage IIIb or IV which are known to express HER-2neu 1 or 2FISH negativeErtumaxomab will be administered at 7 day intervals by constant rate 3 hour intravenous iv infusions according to the following sequential dose schedule 10 µg day 0 and thereafter 100 µg flat doses once every 7 days 1 day for a maximum of up to 12 weeks or until disease progression or any other unacceptable toxicity
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| EudraT number 2006-005017-36 | None | None | None |