RecruitingPhase 2NCT07722741

Personalized Neoantigen Vaccine Plus IL-12 (INO-9012) Versus Active Surveillance in Subjects With High-Risk HCC

IMPACT31: A Randomized Open-label, Multi-center, Phase II Adjuvant Study of a Personalized Neoantigen DNA Vaccine (GNOS-PV02) and Plasmid Encoded IL-12 (INO-9012) Versus Active Surveillance in Subjects With High-Risk HCC


Sponsor

Geneos Therapeutics

Enrollment

90 participants

Start Date

Sep 1, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

This is a randomized, open-label, multi-site Phase II study of a personalized neoantigen DNA vaccine (GNOS-PV02) and plasmid encoded IL-12 (INO-9012) in subjects with histologically or cytologically confirmed diagnosis of HCC based on pathology report, who were eligible to undergo definitive resection, have demonstrated laboratory, radiographic and/or pathologic high-risk criteria for recurrence (described under eligibility), have no evidence of disease (NED) as per MRI approximately 28 days post resection, and are able to provide a tissue sample for personalized neoantigen DNA vaccine development.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying Electroporation Device, a biological treatment called GNOS-PV02 + INO-9012 delivered by intradermal injection, followed by electroporation, and others for people with hcc. The study is currently recruiting participants at 8 locations. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALGNOS-PV02 + INO-9012 delivered by intradermal injection, followed by electroporation

delivered by intradermal injection and electroporation

DEVICEElectroporation Device

GNOS-PV02 + INO-9012 ID followed by electroporation

BIOLOGICALINO-9012

cytokine interleukin-12 (IL-12), a vaccine adjuvant


Locations(8)

Emory University

Atlanta, Georgia, United States

Louisiana State University Health Sciences Center

New Orleans, Louisiana, United States

Johns Hopkins University

Baltimore, Maryland, United States

University of Michigan

Ann Arbor, Michigan, United States

Icahn School of Medicine at Mount Sinai

New York, New York, United States

MD Anderson Cancer Center

Houston, Texas, United States

Fred Hutchinson Cancer Center

Seattle, Washington, United States

Auckland City Hospital (Te Toka Tumai)

Auckland, New Zealand

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

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NCT07722741


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