Clinical Trial

A DNAJB1-PRKACA Fusion Kinase Peptide Vaccine Combined With Glutamine Antagonist DRP-104, Nivolumab, and Ipilimumab in Patients With Advanced Stage Fibrolamellar Carcinoma (FLC)

Not Yet Recruiting Phase 1
View on ClinicalTrials.gov →
Summary
The purpose of this study is to determine whether the combination of a neoantigen vaccine targeting the DNAJB1-PRKACA fusion kinase in combination with DRP-104, Nivolumab and Ipilimumab is safe and yields a clinically compelling antitumor activity measured as based on objective response rate (ORR, assessed by RECIST 1.1). Secondary objectives include progression-free survival (PFS) and overall survival (OS).
Protocol Amendment History 2 changes
notable Primary completion pushed: 2026-05 -> 2030-08 2026-05-07
minor Completion pushed: 2030-05 -> 2030-08 2026-05-07
Trial Details
NCT Number NCT07430202
Lead Sponsor Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Collaborators: Dracen Pharmaceuticals, Inc., Cancer Research Institute, New York City, Fibrolamellar Cancer Foundation
Conditions Liver Cancer (Fibrolamellar Hepatocellular Cancer (FLC))
Enrollment 27 participants
Start Date 2026-08
Primary Completion 2030-08 (estimated)
Study Completion 2030-08 (estimated)
Updated on ClinicalTrials.gov 2026-05-06