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Personalized Neoantigen Vaccine Plus IL-12 (INO-9012) Versus Active Surveillance in Subjects With High-Risk HCC
Sponsor: Geneos Therapeutics
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
GNOS-PV02 + INO-9012 delivered by intradermal injection, followed by electroporation
delivered by intradermal injection and electroporation
Electroporation Device
GNOS-PV02 + INO-9012 ID followed by electroporation
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