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NCT00522457 · ClinicalTrials.gov registry record · Phase 2
Phase II Study With the Trifunctional Antibody Ertumaxomab to Treat Metastatic Breast Cancer After Progression on Trastuzumab Therapy
A Phase 2 study, sponsored by Neovii Biotech.
- Terminated
- Registry status
- Phase 2
- Development phase
- 19
- Enrollment target
NCT00522457 is a Phase 2 study that was terminated before completion, run by Neovii Biotech. The registered enrollment target is 19 participants.
The verdict
NCT00522457, a Phase 2 study, was terminated before completion, sponsored by Neovii Biotech.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 19 participants
- Enrollment target
Study Summary
This study has the purpose to demonstrate clinical efficacy of the investigational new drug ertumaxomab in patients with human epidermal growth factor receptor-2 (HER-2/neu) overexpressing (3+ or 2+ with a positive Fluorescence In Situ Hybridization (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.
Interventions
- DRUG ertumaxomab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 19 participants |
| Start Date | 2008-01 |
| Est. Completion | 2009-12 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00522457
The ClinicalTrials.gov registry entry for NCT00522457 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 19 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Neovii Biotech, which has 5 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which ertumaxomab is the first listed.
NCT00522457 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00522457 about?
NCT00522457 is a clinical study titled "Phase II Study With the Trifunctional Antibody Ertumaxomab to Treat Metastatic Breast Cancer After Progression on Trastuzumab Therapy". This study has the purpose to demonstrate clinical efficacy of the investigational new drug ertumaxomab in patients with human epidermal growth factor receptor-2 (HER-2/neu) overexpressing (3+ or 2+ with a positive Fluorescence In Situ Hybridization (FISH) test result) metastatic breast cancer progr...
What is the current status of trial NCT00522457?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 19 participants. The study started on 2008-01. Estimated completion is 2009-12.
What interventions are being tested in trial NCT00522457?
The interventions under investigation include: ertumaxomab (DRUG).
Who is sponsoring clinical trial NCT00522457?
This trial is sponsored by Neovii Biotech, which has 5 total clinical trials registered on ClinicalTrials.gov.
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