drugset / Trial / NCT01789099

A Phase I/IIa Study of UV1 Vaccination in Patients With Non Small Cell Lung Cancer.

NCT01789099

Phase 1/2 Completed 18 enrolled Ultimovacs ASA Oslo University Hospital · collab
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

EvaluationDrugModalityDoseRoute
Subject UV1 Peptide 100 ug Intrathecal
Subject UV1 Peptide 300 ug Intrathecal
Subject UV1 Peptide 700 ug Intrathecal
Background sargramostim Protein / enzyme biologic Intrathecal