NCT05937295: FusionVAC22

FusionVAC22_01: DNAJB1-PRKACA Fusion Transcript-based Peptide Vaccine Combined with Immune Checkpoint Inhibition for Fibrolamellar Hepatocellular Carcinoma and Other Tumor Entities Carrying the Oncogenic Driver Fusion

Recruiting now Phase 1 Last updated 4 December 2024

What this trial tests

Phase 1 trial testing Fusion-VAC-XS15 in Fibrolamellar Hepatocellular Carcinoma in 20 participants. Currently enrolling.

Timeline

26 September 2023

Primary endpoint
1 September 2026

1 January 2027

Quick facts

Lead sponsor	University Hospital Tuebingen
Phase	Phase 1
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	20
Start date	26 September 2023
Primary completion	1 September 2026
Estimated completion	1 January 2027
Sites	1 location across Germany

Drugs / interventions tested

• Fusion-VAC-XS15 — full drug profile →

Conditions studied

• Fibrolamellar Hepatocellular Carcinoma — all drugs for Fibrolamellar Hepatocellular Carcinoma →

Sponsor

University Hospital Tuebingen

Who can join

18 and older, any sex, with Fibrolamellar Hepatocellular Carcinoma. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• To assess immunogenicity in terms of induction of peptide specific T-cell responses
  Time frame: through study completion, an average of 1 year
  The percentage of patients with an induction of T-cell response until 28 days after second vaccination will be the primary endpoint for efficacy. Peptide stimulated Peripheral Blood Mononuclear Cells (PBMCs) are analyzed by enzyme-linked immunospot (ELISPOT).
• Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] of the peptide vaccine in combination with anti-PD-L1 immune checkpoint inhibition
  Time frame: through study completion, an average of 1 year
  The safety and toxicity of the personalized multi-peptide vaccine in combination with the toll-like receptor1/2 ligand XS15 with anti-PD-L1 immune checkpoint inhibition (ICI) will be determined based on the Common Terminology Criteria for Adverse Events (CTCAE version 5.0) and assessed in a descriptive manner.

Sponsor's own description

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 combination with anti-programmed cell death-ligand 1 immune checkpoint inhibition (ICI) by Atezolizumab (TecentriqTM) in patients with Fibrolamellar hepatocellular carcinoma (FL-HCC) or other cancer entities carrying the DNAJB1-PRKACA fusion transcript.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Therapeutic cancer vaccines: advancements, challenges, and prospects.
   Fan T, Zhang M, Yang J, Zhu Z, et al · · 2023 · cited 314× · PMID 38086815 · DOI 10.1038/s41392-023-01674-3
2. Harnessing innate immune pathways for therapeutic advancement in cancer.
   Hu A, Sun L, Lin H, Liao Y, et al · · 2024 · cited 150× · PMID 38523155 · DOI 10.1038/s41392-024-01765-9
3. Toll-like receptors in health and disease.
   Wang K, Huang H, Zhan Q, Ding H, et al · · 2024 · cited 42× · PMID 38685971 · DOI 10.1002/mco2.549
4. A Comprehensive Review on Cancer Vaccines and Vaccine Strategies in Hepatocellular Carcinoma.
   Tojjari A, Saeed A, Singh M, Cavalcante L, et al · · 2023 · cited 37× · PMID 37631925 · DOI 10.3390/vaccines11081357
5. Hepatocellular Carcinoma: Old and Emerging Therapeutic Targets.
   Pessino G, Scotti C, Maggi M, Immuno-Hub Consortium. · · 2024 · cited 29× · PMID 38473265 · DOI 10.3390/cancers16050901
6. Immunotherapy in liver cancer: overcoming the tolerogenic liver microenvironment.
   Liu Y, Yang H, Li T, Zhang N. · · 2024 · cited 23× · PMID 39295859 · DOI 10.3389/fimmu.2024.1460282
7. FusionVAC22_01: a phase I clinical trial evaluating a DNAJB1-PRKACA fusion transcript-based peptide vaccine combined with immune checkpoint inhibition for fibrolamellar hepatocellular carcinoma and other tumor entities carrying the oncogenic driver fusion.
   Hackenbruch C, Bauer J, Heitmann JS, Maringer Y, et al · · 2024 · cited 7× · PMID 38606105 · DOI 10.3389/fonc.2024.1367450
8. Insights in Molecular Therapies for Hepatocellular Carcinoma.
   Heumann P, Albert A, Gülow K, Tümen D, et al · · 2024 · cited 5× · PMID 38791911 · DOI 10.3390/cancers16101831