A Phase I Study To Evaluate The Antitumor Activity And Safety Of AVX901
This study is not yet open for participant recruitment.
Verified February 2012 by Duke University
First Received on January 24, 2012. Last Updated on February 1, 2012 History of Changes
| Sponsor: | Duke University |
|---|---|
| Collaborator: | Department of Defense |
| Information provided by (Responsible Party): | Duke University |
| ClinicalTrials.gov Identifier: | NCT01526473 |
Purpose
HER2 is a protein that is over expressed in 20-30% of breast cancers. It is also found associated with lung, gastric, ovarian, and pancreatic cancers. Although there are existing therapies that can target HER2, most patients will eventually experience progression of their disease even though their cancer continues to express HER2. Therefore, new approaches are needed for treating tumors that express HER2.
This clinical trial will use an investigational cancer vaccine called HER2 VRP or AVX901. The vaccine is based on a virus called Venezuelan equine encephalitis but it has been changed so it cannot cause active infection. Instead, the virus has been changed so it tells the immune system to attack cancer cells which make HER2.
The objectives of the study are to evaluate the safety of immunization with HER2 VRP in patients with advanced or metastatic malignancies that express HER2, and to test whether immunization will causes a strong immune system attack against the cancer.
| Condition | Intervention | Phase |
|---|---|---|
| HER2+ Cancer | Biological: AVX901 | Phase I |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label |
| Official Title: | A Phase I Study To Evaluate The Antitumor Activity And Safety Of DUKE-002-VRP(HUHER2-ECD+TM), An Alphaviral Vector Encoding The HER2 Extracellular Domain And Transmembrane Region, In Patient With Locally Advanced Or Metastatic Human Epidermal Growth Factor Receptor 2-Positive (HER2+) Cancers Including Breast Cancer |
