drugset / Trial / NCT03633110

Safety, Tolerability, Immunogenicity, and Antitumor Activity of GEN-009 Adjuvanted Vaccine

NCT03633110

Phase 1/2 Completed 24 enrolled Genocea Biosciences, Inc.
Non-randomizedSingle-groupOpen-labelTreatment

Summary

In this study, Genocea is evaluating an investigational, personalized adjuvanted vaccine, GEN-009, that is being developed for the treatment of patients with solid tumors. A proprietary tool developed by Genocea, called ATLAS™ (Antigen Lead Acquisition System) will be used to identify neoantigens in each patient's tumor that are recognized by their CD4 and/or CD8 T cells. ATLAS-identified neoantigens will then be incorporated into a patient's personalized vaccine in the form of synthetic long peptides (SLPs).

Timeline

Start
2018-08-29
Primary completion
2021-12-08
Completion
2022-02-28

Drugs

EvaluationDrugModalityDoseRoute
Subject GEN-009 Vaccine Subcutaneous
Background Nivolumab Monoclonal antibody
Background Pembrolizumab Monoclonal antibody