NCT06789198

Peptide Vaccine for Fibrolamellar Hepatocellular Carcinoma Patients and Other Tumor Entities Carrying the Driver Fusion DNAJB1-PRKACA

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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: University Hospital Tuebingen · Academic / Other
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

To date, beyond surgery, there are no approved drugs and no standard of care for the treatment of FLC patients. Relapse rates after remission inducing therapies (surgery, radiation, liver transplant, systemic therapy approaches) are very high. With FusionVAC-XS15 the sponsor aims to activate the immune system specifically against the gene fusion to eradicate remaining tumor cells to improve disease remission and finally enable long-term disease-free survival. Patients with confirmed diagnosis of FL-HCC or other cancer entities carrying the DNAJB1-PRKACA fusion transcript and fulfilling the below outlined inclusion criteria will be enrolled into the clinical trial. The trial population will consist of both genders. Gender distribution in the trial is supposed to reflect the distribution in the real patient population; there will be no a priori defined quantitative ratio between females and males. FusionVAC-22 peptide will be administered subcutaneously (s.c.) with the TLR1/2 ligand XS15 (50 µg) emulsified in Montanide ISA 51. A total of two vaccinations are planned, 4 weeks apart from each other. If no sufficient T cell response is achieved at the end of treatment visit (28 days after last vaccination) a booster vaccination at day 56 (+7 days) after the second vaccination can be applied

Conditions

• Fibrolamellar Hepatocellular Carcinoma (FLC)

Interventions

Type	Name	Description
DRUG	Vaccination of Fusion-VAC-XS15	FusionVAC-22 peptide will be administered subcutaneously (s.c.) with the TLR1/2 ligand XS15 (50 µg) emulsified in Montanide ISA 51 VG (1:1). A total of two vaccinations are planned, 4 weeks apart from each other. If no sufficient T cell response is achieved at the end of treatment visit (28 days after last vaccination) a booster vaccination at day 56 (+7 days) after the second vaccination can be applied

Timeline

• Start date: 2025-07-08
• Primary completion: 2028-11-01
• Completion: 2028-11-01
• First posted: 2025-01-23
• Last updated: 2026-02-12

Locations

2 sites across 1 country: Germany