Fibrolamellar Hepatocellular Carcinoma (FLC)Phase 1FusionVAC22_02NCT06789198
Peptide Vaccine for Fibrolamellar Hepatocellular Carcinoma Patients and Other Tumor Entities Carrying the Driver Fusion DNAJB1-PRKACA
A Phase 1 study testing Vaccination of Fusion-VAC-XS15 in people with Fibrolamellar Hepatocellular Carcinoma (FLC), run by University Hospital Tuebingen at 2 sites in Germany.
Trial 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 Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Fibrolamellar Hepatocellular Carcinoma (FLC)
- What is being tested?
- Vaccination of Fusion-VAC-XS15
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesGermany
- Study dates
- 8 Jul 2025to Nov 2028
- Phase
- Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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,
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- 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 now because 6 adult patients have been enrolled in the study.
- Patients <18 years must have a body weight ≥ 40 kg
- 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
- Bilirubin ≤ 3 mg/dl
- Negative serological hepatitis B test or negative PCR in case of positive serological test without evidence of an active infection, negative testing of hepatitis C RNA, negative HIV test within 6 weeks prior to study inclusion.
- Female patients of child bearing potential (FCBP) and male patients with partners of child bearing potential who are sexually active must agree to the use of two effective forms (at least one highly effective method) of contraception. This should be started from the signing of the informed consent and be continued until 3 months (both female and male patients) after last dose of the vaccination
- For FCBP two negative pregnancy tests (sensitivity of at least 25 mIU/mL) prior to first application of the study drug (vaccination at visit V1), one at screening and the other one at visit V1 prior (< 24h) to first vaccination.
- Postmenopausal or evidence of non-child-bearing status.
- Be willing to minimize blood and body fluid exposure after vaccination until end of study
- Refrain from sperm or ovary egg donation
- Refrain from blood donation
Who cannot join
- 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,
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- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Helmut Salih, Prof. Dr. contact
Germany2 sites, 2 recruiting
- Recruiting
University Hospital Tuebingen
Tübingen, 72076
Helmut Salih, Prof. Dr., +49 707129 ext. 83275, kketi@med.uni-tuebingen.de
Helmut Salih, Prof. Dr.
- Recruiting
Universitätsklinikum Tübingen, Kinderheilkunde I
Tübingen, 72076
Juliane Walz, Prof.Dr., kketi@med.uni-tuebingen.de
Martin Ebinger, Prof. Dr.
About this study
Official title: FusionVAC22_02: DNAJB1-PRKACA Fusion Transcript-based Peptide Vaccine for Fibrolamellar Hepatocellular Carcinoma Patients and Other Tumor Entities Carrying the Oncogenic Driver Fusion
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
Read the 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 three vaccinations are planned, 4 weeks apart from each other.
- Being tested
- Vaccination of Fusion-VAC-XS15
- Keywords
- DNAJB1-PRKACA fusion transcript, Fibrolamellar hepatocellular carcinoma (FL-HCC)
- Medical subject headings
- Fibrolamellar hepatocellular carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vaccination of Fusion-VAC-XS15Drug
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 three vaccinations are planned, 4 weeks apart from each other.
| Study group | Role | What they receive |
|---|---|---|
| Trial conduction | Experimental | All trial participants will recieve three vaccinations with Fusion-VAC-XS15. Receives: Drug: Vaccination of Fusion-VAC-XS15 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of vaccination
Primary objectives of the planned trial are to assess immunogenicity in terms of induction of peptide specific T-cell responses
Measured: until 28 days after third 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.
Measured: from first vaccination until 12 months after last vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2025
- Study start8 Jul 2025
- Primary completionNov 2028 (estimated)
- Study completionNov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fibrolamellar Hepatocellular Carcinoma (FLC)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Tuebingen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06789198
- Sponsor's protocol ID
- FusionVAC22_02
- Other IDs
- 2024-519387-41-00
- Acronym
- FusionVAC22_02
- Status last verified
- Sep 2026
- First submitted
- 17 Jan 2025
- Last updated
- 14 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No