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RECRUITING
NCT07722741
PHASE2

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

Sponsor: Geneos Therapeutics

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

90

Start Date

2026-09

Completion Date

2032-06

Last Updated

2026-09-04

Healthy Volunteers

No

Conditions

Interventions

BIOLOGICAL

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

delivered by intradermal injection and electroporation

DEVICE

Electroporation Device

GNOS-PV02 + INO-9012 ID followed by electroporation

BIOLOGICAL

INO-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