GNOS-PV02 Personalized Neoantigen Vaccine and Plasmid Encoded IL-12 (INO-9012) Versus Active Surveillance in Subjects With High-Risk HCC

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
Geneos Therapeutics
Study ID
NCT07722741
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • GNOS-PV02 + INO-9012 delivered by intradermal injection, followed by electroporation — BIOLOGICAL
    delivered by intradermal injection and electroporation
  • Electroporation Device — DEVICE
    GNOS-PV02 + INO-9012 ID followed by electroporation

Study Details

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.

Key Dates

First listed
Jul 23, 2026
Start date
Sep 30, 2026
Status verified
Jul 2026
Primary completion
Sep 30, 2029
Completion
Jun 30, 2032

Study Design

Enrollment
90 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm A
    Arm A: GNOS-PV02 + INO-9012 ID followed by electroporation every 3 weeks for 4 doses, then every 9 weeks (Q9W) until week 104, then every 12 weeks (Q12W) until week 260 followed by 3 years follow-up survival
  • No Intervention: Arm B
    Arm B: Active Surveillance for 5 years or until recurrence, plus 3 years follow-up survival.

Primary Outcome Measure

Recurrence-free survival [ Time Frame: Up to 5 years ]

Locations (1)

FacilityCityStateZIPSite coordinators
Johns Hopkins UniversityBaltimoreMaryland21287
Principal Investigator, MD
[email protected]
410-955-8893

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