FusionVAC22_02: DNAJB1-PRKACA Fusion Transcript-based Peptide Vaccine for Fibrolamellar Hepatocellular Carcinoma Patients and Other Tumor Entities Carrying the Oncogenic Driver Fusion

NCT06789198 Phase 1 RECRUITING

The aim of this clinical trial is to evaluate the immunogenicity along with safety and toxicity as well as first efficacy of a DNAJB1-PRKACA fusion transcript-based peptide vaccine (Fusion-VAC-XS15) in patients with FL-HCC or other cancer entities carrying the DNAJB1-PRKACA fusion transcript as adjuvant treatment

Details

Lead sponsor	University Hospital Tuebingen
Phase	Phase 1
Status	RECRUITING
Enrolment	20
Start date	2025-07-08
Completion	2028-11

Conditions

• Fibrolamellar Hepatocellular Carcinoma (FLC)

Interventions

• Vaccination of Fusion-VAC-XS15

Primary outcomes

• Efficacy of vaccination — until 84 days after second vaccination
  Primary objectives of the planned trial are to assess immunogenicity in terms of induction of peptide specific T-cell responses
• Safety of the vaccination — from first vaccination until 12 months after last vaccination
  Primary objective of the planned trial is to assess safety and toxicity of the peptide vaccine. The safety and toxicity of the DNAJB1-PRKACA fusion transcript-based peptide vaccine is determined based on the Common Terminology Criteria for Adverse Events (CTCAE V 5.0) and assessed in a descriptive manner.

Countries

Germany