drugset / Trial / NCT05898763

TEIPP Immunotherapy in Patients With NSCLC

NCT05898763

Phase 1/2 Completed 26 enrolled Erasmus Medical Center
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

EvaluationDrugModalityDoseRoute
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