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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: Clinical Trial Phase 2 study, sponsored by Neovii Biotech.
NCT00522457 is a Phase 2 study that was terminated before completion, run by Neovii Biotech. The registered enrollment target is 19 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (86% lower). According to ClinicalTrials.gov, the official US trial registry.
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 |
Why NCT00522457 stopped before completion
NCT00522457 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 19 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (86% lower).
The record links to 0 conditions, and to 1 intervention - of which ertumaxomab is the first listed.
NCT00522457 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00522457's enrollment target sits among peer trials
19 1894th of 2000 higher than 103 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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