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NOT YET RECRUITING
NCT07722741
PHASE2

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

Sponsor: Geneos Therapeutics

View on ClinicalTrials.gov

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

BIOLOGICAL

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

delivered by intradermal injection and electroporation

DEVICE

Electroporation Device

GNOS-PV02 + INO-9012 ID followed by electroporation

BIOLOGICAL

INO-9012

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

Locations (1)

Johns Hopkins University

Baltimore, Maryland, United States