drugset / Trial / NCT05898763
TEIPP Immunotherapy in Patients With NSCLC
NaSequentialOpen-labelTreatment
Summary
In this multicenter, open label non-randomized phase I/II dose escalation study with extension cohort HLA-A\*0201-positive patients with non small cell lung cancer (NSCLC) can be included. The primary aim of this study is determine the safety, tolerability and immune modulating effects of the therapeutic LRPAP1 synthetic long peptide (LRPAP7-30V-SLP) vaccine (TEIPP24) at different doses. Secondary objectives are to assess the specificity and immune modulatory effects of the vaccine, to assess the antigen and immune status of the patients, and to determine progression free survival (PFS), overall survival (OS), and the radiological tumor response up to one year after first vaccination.
Timeline
- Start
- 2021-09-29
- Primary completion
- 2024-04-30
- Completion
- 2024-04-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | TEIPP24 | Vaccine | 20 ug | Subcutaneous |
| Subject | TEIPP24 | Vaccine | 40 ug | Subcutaneous |
| Subject | TEIPP24 | Vaccine | 100 ug | Subcutaneous |
| Background | Pembrolizumab | Monoclonal antibody | — | — |
| Background | incomplete Freund's adjuvant | Other / unclassified | — | Subcutaneous |