Clinical Trial

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

Study acronym: IMPACT31
Not Yet Recruiting Phase 2
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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.
Protocol Amendment History 1 change
notable Trial sites expanded: 3 -> 8 locations 2026-08-15
Trial Details
NCT Number NCT07722741
Lead Sponsor Geneos Therapeutics
Conditions HCC
Enrollment 90 participants
Start Date 2026-09
Primary Completion 2029-09 (estimated)
Study Completion 2032-06 (estimated)
Updated on ClinicalTrials.gov 2026-08-14