drugset / Trial / NCT01789099
A Phase I/IIa Study of UV1 Vaccination in Patients With Non Small Cell Lung Cancer.
NaSingle-groupOpen-labelTreatment
Summary
In this study, up to 21 patients with lung cancer will receive UV1 (a therapeutic synthetic peptide vaccine) at different dose levels. The safety and tolerability of UV1 as well as immunological response will be assessed. The purpose of this study is to select a biological dose of peptides for further clinical trials. Study recruitment completed at 6 patients in every dose level. The main study treatment phase of this study is completed and will be reported separately. Follow-up is ongoing
Timeline
- Start
- 2013-04-08
- Primary completion
- 2016-02-29
- Completion
- 2020-06-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | UV1 | Peptide | 100 ug | Intrathecal |
| Subject | UV1 | Peptide | 300 ug | Intrathecal |
| Subject | UV1 | Peptide | 700 ug | Intrathecal |
| Background | sargramostim | Protein / enzyme biologic | — | Intrathecal |