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

ClinicalTrials.gov ID: NCT03633110

Public ClinicalTrials.gov record NCT03633110. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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Official title

A Phase 1/2a Study to Evaluate the Safety, Tolerability, Immunogenicity, and Antitumor Activity of GEN-009 Adjuvanted Vaccine in Adult Patients With Selected Solid Tumors

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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).

Study identification

NCT ID: NCT03633110
Recruitment status: Completed
Study type: Interventional
Phase: Phase 1, Phase 2
Lead sponsor: Genocea Biosciences, Inc.; Industry
Enrollment: 24 participants

Conditions and interventions

Conditions

Interventions

Biological · Drug

Eligibility (public fields only)

Age range: 18 Years and older
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Aug 28, 2018
Primary completion: Dec 7, 2021
Completion: Feb 27, 2022
Last update posted: Apr 18, 2022

2018 – 2022

United States locations

U.S. sites: 11
U.S. states: 10
U.S. cities: 11

Facility	City	State	ZIP	Site status
UC San Diego Moores Cancer Center	La Jolla	California	92093	—
John Wayne Cancer Institute - Providence Saint John's Health Center	Santa Monica	California	90404	—
University of Colorado, Anschutz Cancer Pavilion	Aurora	Colorado	80045	—
Dana-Farber Cancer Institute	Boston	Massachusetts	02215	—
Karmanos Cancer Institute	Detroit	Michigan	48201	—
University of Nebraska Medical Center	Omaha	Nebraska	68198	—
Columbia University Medical Center - Herbert Irving Pavilion	New York	New York	10032	—
Hospital of the University of Pennsylvania	Philadelphia	Pennsylvania	19104	—
The Sarah Cannon Research Institute	Nashville	Tennessee	37203	—
The University of Texas MD Anderson Cancer Center	Houston	Texas	77030	—
University of Wisconsin Carbone Cancer Center	Madison	Wisconsin	53792	—

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT03633110, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Apr 18, 2022 · Synced Sep 12, 2026

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The complete protocol, eligibility criteria, and contact information for NCT03633110 live on ClinicalTrials.gov.

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