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GSK Biologicals' 719125 · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Group A | EXPERIMENTAL | Patients receive study vaccinations in 3 consecutive cycles: * In Cycle 1 each patients will receive six vaccinations at two-week intervals followed by evaluation. * In Cycle 2, subjects will patients six vaccinations at two-week intervals followed by evaluation. * In Cycle 3, subjects will patients six vaccinations at three-week intervals. |
| Group B | EXPERIMENTAL | Patients receive study vaccinations as second-line therapy |
| Name | Type | Description |
|---|---|---|
| GSK Biologicals' 719125 | BIOLOGICAL | Patients receive six vaccinations at two-week intervals |
Inclusion criteria: * Female. * At least 18 years of age. * Written informed consent to participate in the study. * Diagnosis of advanced breast cancer. Furthermore, for patients being considered for second-line study treatment only: The patient has received a first-line chemotherapy together with ...
GSK Biologicals' 719125 is an investigational monoclonal antibody developed by GSK plc for the treatment of HER2-positive metastatic breast cancer. It was studied as a dHER2 vaccine in a Phase 1 clinical trial. It is not an approved therapy and remains in early clinical development.
GSK Biologicals' 719125 was studied for the treatment of HER2-positive metastatic breast cancer, a neoplasm of the breast. The Phase 1 trial enrolled adult female patients with HER2-positive metastatic disease. Because development was limited to early-stage testing, the agent is not an approved treatment for any indication.
GSK Biologicals' 719125 is developed by GSK plc, which trades under the ticker GSK. The asset is part of the company's oncology pipeline and was evaluated as a monoclonal antibody-based vaccine approach in breast cancer.
GSK Biologicals' 719125 is in Phase 1 development. Its only recorded clinical trial, NCT00140738, was a Phase 1 study that has been completed. The agent is investigational and has not been approved by the FDA or any other regulatory authority for commercial use.
GSK Biologicals' 719125 was evaluated in one clinical trial, NCT00140738, titled a Safety and Immunogenicity Study of the New dHER2 Vaccine to Treat HER2-positive Metastatic Breast Cancer. The Phase 1 trial enrolled 3 female patients aged 18 years and older across Belgium, Colombia, France, Italy, and Peru, and it is now completed.
GSK Biologicals' 719125 is described as a monoclonal antibody and was tested in a trial of a dHER2 vaccine for HER2-positive metastatic breast cancer. The Phase 1 study assessed safety and immunogenicity in a biomarker-selected population of adult women. It remains an investigational agent in early clinical development.