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

StatusRecruiting
PhasePhase 1
Started

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Record History

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  1. Recruitment opened Show 5 more changesShow less
    • Primary and study completion dates: Sep 2030 to Oct 2030
    • Start date: Sep 2026 to Oct 2026
    • Eligibility criteria expanded, about 41 words
    • Secondary endpoints: details revised at 2 of 2 entries
    • Site details revised
  2. Primary and study completion dates: Aug 2030 to Sep 2030
    • Start date: Aug 2026 to Sep 2026
    v3
  3. Primary completion pushed from May 2026 to Aug 2030
    • Start date: May 2026 to Aug 2026
    • Study completion pushed from May 2030 to Aug 2030
    v2
  4. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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).
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
(from sponsor)		 Liver Cancer (Fibrolamellar Hepatocellular Cancer (FLC))
Related terms Carcinoma, Fibrolamellar hepatocellular carcinoma, Liver Neoplasms
Enrollment 27 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov