drugset / Trial / NCT01880411
Phase I, Open-Label Study of the Safety, Tolerability, and Immunogenicity PEK Fusion Protein Vaccine
NaSingle-groupOpen-labelTreatment
Summary
Phase I, Open-Label Study of the Safety, Tolerability, and Immunogenicity of a Three Dose Regimen of Escalating Doses of PEK Fusion Protein Vaccine in Women with LSIL or HSIL. PEK fusion protein vaccine (PEK + GPI-0100) is safe and well tolerated in patients with low-grade squamous intraepithelial lesions (LSIL) or high grade squamous intraepithelial lesions (HSIL) of the cervix and induces a measurable immune response.
Timeline
- Start
- 2013-06
- Primary completion
- 2014-01
- Completion
- 2014-06
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | PE-E7-K3 | Unknown | 0.1 mg | Other |
| Subject | PE-E7-K3 | Unknown | 0.3 mg | Other |
| Subject | PE-E7-K3 | Unknown | 1.2 mg | Other |
| Background | GPI-0100 | Other / unclassified | — | — |