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

NCT06789198 | Recruiting Phase 1 DMC

• 2 other identifiers: FusionVAC22_022024-519387-41-00
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

Brief 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

Conditions

Fibrolamellar Hepatocellular Carcinoma (FLC)

Keywords

DNAJB1-PRKACA fusion transcript; Fibrolamellar hepatocellular carcinoma (FL-HCC)

Outcome Measures

Primary Outcomes (2)

• Efficacy of vaccination

  Primary objectives of the planned trial are to assess immunogenicity in terms of induction of peptide specific T-cell responses

  until 84 days after second vaccination

• Safety of the 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.

  from first vaccination until 12 months after last vaccination

Study Arms (1)

Trial conduction

EXPERIMENTAL

All trial participants will recieve at least two vaccinations with Fusion-VAC-XS15 and one optional boster vaccination depending on the T-cell response

Drug: Vaccination of Fusion-VAC-XS15

Interventions

Vaccination of Fusion-VAC-XS15 DRUG

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

Trial conduction

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Ability to understand and willingness to sign a written informed consent document.
• Histologically confirmed Fibrolamellar hepatocellular carcinoma (FL-HCC) or other malignant disease in an adjuvant setting, defined as:
• Presence of DNAJB1-PRKACA fusion transcript, assessed by RNA-based NGS or RT-PCR
• Achievement of complete remission (CR) according to RECIST1.1 by any of the following therapeutic measures:
• surgical procedures,
• radiotherapy,
• local therapeutic measures (e.g. TACE, SIRT, etc.)
• systemic treatment (e.g. chemotherapy)
• Age ≥ 12 years. Note: Subjects aged ≥ 12 years but \< 18 are eligible to enroll only after 6 adult patients have been enrolled in the study.
• Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.
• Adequate laboratory values for
• Absolute Lymphocyte Count \> 500 /µl
• Platelets \> 50.000 /µl
• Creatinine clearance GFR \> 30 ml/min
• Alanine aminotransferase (ALT) and aminotransferase (AST) ≤ 5 times upper limit range

You may not qualify if:

• Pregnant or breastfeeding.
• Unwilling or unable to follow the study schedule for any reason.
• Concurrent or previous treatment within 14 days in another interventional clinical trial with an investigational anti-cancer treatment.
• Concurrent treatment with any of the following therapeutic measures:
• surgical procedures,
• radiotherapy,
• local therapeutic measures (e.g. TACE, SIRT, etc.)
• systemic treatment (e.g. chemotherapy)
• Concurrent or previous treatment within 6 months with an anti-cancer vaccine treatment.
• Any live vaccine therapy used for prevention of infectious diseases within 28 days of study treatment
• Known sensitivity to or history of allergic reactions to investigational drug.
• Active autoimmune disease that has required systemic treatment in the past 2 years, or a documented history of clinically severe autoimmune disease, or a syndrome that requires systemic steroids (\> 10 mg per day) or immunosuppressive agents (Please note, patients after liver transplantation requiring immunosupressants are allowed).
• Uncontrolled intercurrent illness including, but not limited to, uncontrolled infection, symptomatic congestive heart failure, unstable angina, cardiac arrhythmia, metastatic cancer, or psychiatric illness/social situations that would limit compliance with study requirements.

Sponsors & Collaborators

• University Hospital Tuebingen: lead

Study Sites (2)

University Hospital Tuebingen

Tübingen, 72076, Germany

RECRUITING

Universitätsklinikum Tübingen, Kinderheilkunde I

Tübingen, 72076, Germany

NOT YET RECRUITING

MeSH Terms

Conditions

Fibrolamellar hepatocellular carcinoma

Central Study Contacts

Juliane Walz, Prof. Dr.

CONTACT

+49 707129; kketi@med.uni-tuebingen.de

Helmut Salih, Prof. Dr.

CONTACT

kketi@med.uni-tuebingen.de

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 17, 2025
• First Posted: January 23, 2025
• Study Start: July 8, 2025
• Primary Completion (Estimated): November 1, 2028
• Study Completion (Estimated): November 1, 2028
• Last Updated: February 12, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

DE (2)