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

NCT07722741 | Not Yet Recruiting Phase 2 DMC FDA Drug FDA Device

• 1 other identifier: GT-31
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

HCC

Outcome Measures

Primary Outcomes (1)

• Recurrence-free survival

  RFS is defined as the time from randomization to any recurrence (local, locoregional, regional or distant), occurrence of new primary HCC, as assessed by the investigator, or death due to any cause, whichever occurs first.

  Up to 5 years

Secondary Outcomes (3)

• Incidence of treatment emergent adverse events (safety and tolerability)

  Up to 5 years

• Time to extra-hepatic spread or macro-vascular invasion

  Up to 5 years

• Overall survival

  Up to 5 years on study + 3 years follow up

Study Arms (2)

Personalized Immunotherapy for Cancer:

EXPERIMENTAL

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

Biological: GNOS-PV02 + INO-9012 delivered by intradermal injection, followed by electroporation; Device: Electroporation Device; Biological: INO-9012

Standard of Care

NO INTERVENTION

Active Surveillance for 5 years or until recurrence, plus 3 years follow-up survival.

Interventions

Electroporation Device DEVICE

GNOS-PV02 + INO-9012 ID followed by electroporation

Personalized Immunotherapy for Cancer:

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

delivered by intradermal injection and electroporation

Personalized Immunotherapy for Cancer:

INO-9012 BIOLOGICAL

cytokine interleukin-12 (IL-12), a vaccine adjuvant

Personalized Immunotherapy for Cancer:

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Written informed consent
• ≥18 years of age
• Histologically or cytologically confirmed diagnosis of HCC (not accepted: fibrolamellar, sarcomatoid, mixed cholangiocarcinoma)
• Child-Pugh Class A liver score
• Documented virology status of hepatitis
• Availability of a representative post-resection tumor tissue sample
• ECOG performance status of 0 or 1
• Adequate organ function
• Women of childbearing potential (WOCBP) and men must be willing to use an adequate method of contraception

You may not qualify if:

• Is currently participating in and receiving study drug or has participated in a study of an investigational agent and received study drug or used an investigation device, within 4 weeks to baseline
• Evidence of residual, recurrent, or metastatic disease at randomization
• Active or history of autoimmune disease or immune deficiency
• Diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug
• Diagnosed additional malignancy within 5 years prior to baseline, except for: (a) non-invasive carcinomas subject to successful curative treatment in the opinion of the investigator which require no further therapy and (b) other malignancies for which subjects have undergone potentially curative therapy and have been considered disease free for at least 3 years prior to screening.
• Active infection requiring systemic therapy
• Is pregnant, breastfeeding or expecting to conceive or father children within the study's projected duration
• History of human immunodeficiency virus (HIV) (HIV I/II antibodies).
• Co-infection with HBV and hepatitis D viral infection
• Co-infection with HBV and HCV
• Has received a live vaccine within 30 days of planned start of study

Sponsors & Collaborators

• Geneos Therapeutics: lead

Study Sites (1)

Johns Hopkins University

Baltimore, Maryland, 21287, United States

Location

Related Links

• Geneos Therapeutics Website - Platform and company information

MeSH Terms

Interventions

rocakinogene sifuplasmid

Central Study Contacts

Joann Peters, MHA

CONTACT

434-825-2551; peters@geneostx.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Adjuvant Therapy, Active Surveillance

Study Record Dates

• First Submitted: July 20, 2026
• First Posted: July 23, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): September 1, 2029
• Study Completion (Estimated): June 1, 2032
• Last Updated: July 28, 2026

Record last verified: 2026-07

Locations

US (1)