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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
2026-07-28
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 (1)
Johns Hopkins University
Baltimore, Maryland, United States