drugset / Trial / NCT07430202
A DNAJB1-PRKACA Fusion Kinase Peptide Vaccine Combined With Glutamine Antagonist DRP-104, Nivolumab, and Ipilimumab in Patients With Advanced Stage Fibrolamellar Carcinoma (FLC)
Phase 1
Not yet recruiting
27 enrolled
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Cancer Research Institute, New York City · collabDracen Pharmaceuticals, Inc. · collabFibrolamellar Cancer Foundation · collab
NaSingle-groupOpen-labelTreatment
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).
Timeline
- Start
- 2026-08
- Primary completion
- 2030-08
- Completion
- 2030-08
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | DNAJB1-PRKACA Peptide Vaccine | Vaccine | 0.3 mg | — |
| Subject | Ipilimumab | Monoclonal antibody | 1 mg/kg | Intravenous |
| Subject | Nivolumab | Monoclonal antibody | 480 mg | Intravenous |
| Subject | sirpiglenastat | Small molecule | 145 mg | Subcutaneous |
| Background | Hiltonol | Other / unclassified | 0.5 mg | — |