AzTrials
AzTrials

ChordomaPhase 1NCT04246671

TAEK-VAC-HerBy Vaccine for Brachyury and HER2 Expressing Cancer

A Phase 1 study testing TAEK-VAC-HerBy in people with Chordoma and HER2-positive Breast Cancer, run by Bavarian Nordic at 9 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

A Phase 1 open label trial of intravenous administration of TAEK-VAC-HerBy vaccine in patients with advanced brachyury and/or HER2- expressing cancer. The study will be completed in 2 stages. In Stage 1 patients will be enrolled and treated according to a 3+3 dose escalation scheme. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Chordoma, HER2-positive Breast Cancer
What is being tested?
TAEK-VAC-HerBy
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
37 participants
Where
9 sitesUnited States
Study dates
10 Aug 2020to 11 Dec 2024
Phase
Phase 1
Are there results?
None posted in the registry

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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • General inclusion criteria, apply to all cohorts:
  • Men and women ≥18 years old.
  • Patients must have histologically documented malignant tumor which is unresectable locally advanced or metastatic.
  • ECOG performance status 0 or 1
  • Patients must have normal organ and bone marrow function as defined in the protocol.
  • Normal left ventricular ejection fraction (LVEF) ≥50%.
Show all 13Show fewer
  • Troponin I within normal limits.
  • A maximum cumulative dose of prior doxorubicin ≤360 mg/m2 or epirubicin ≤720 mg/m2
  • Any approved cancer therapy (except HER2 antibodies) must be completed at least 3 weeks or 5 half-lives for small molecule inhibitors, whichever is shorter, prior to the first planned dose of TVH vaccine.
  • HER-2 positive cancer: Patients are required to be on active treatment with HER2 antibodies (trastuzumab) prior to and during study treatment.
  • Chordoma patients with progressive extracranial chordoma (base of skull is permitted) not amenable for surgical resection with curative intent, nor for radiation therapy will be enrolled.
  • Patients must have recovered (Grade 1 or baseline) from any clinically significant toxicity associated with prior therapy.
  • Patients must have measurable disease by computed tomography (CT) or magnetic resonance imaging (MRI) per RECIST 1.1.

Who cannot join

  • Known metastatic disease to the central nervous system, unless previously treated and responded with a minimum stable disease over 2 CT scans separated at least 4 weeks from each other, and more than 6 weeks since the last dose of dexamethasone.
  • History of allergy or untoward reaction to prior vaccination with vaccinia virus, aminoglycoside antibiotics, ciprofloxacin, or egg products.
  • Subjects should have no known evidence of being immunocompromised.
  • Chronic administration (defined as >5 consecutive days of >15 mg of prednisone (or equivalent) per day) of systemic corticosteroids within 14 days of the first planned dose of TAEK-VAC-HerBy vaccine. Use of inhaled steroids, nasal sprays, eye drops, and topical creams is allowed. Steroids premedication for CT scans is allowed.
  • Clinically significant cardiomyopathy, coronary disease, congestive heart failure (NYHA class III or IV) or reduced as per institutional standards LVEF, poorly controlled hypertension (systolic >180 mm Hg or diastolic >100 mm Hg) or cerebrovascular accident within 1 year.
  • Known history of, or any evidence of active, non-infectious pneumonitis or primary pulmonary fibrosis.

Trial locations and contacts

9 sites in 1 country.

9 sites in 1 country

United States9 sites

  • Georgia Cancer Center Augusta University

    Augusta, Georgia, 30912

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • Mayo Clinic - Jacksonville

    Jacksonville, Florida, 32224

  • Providence Cancer Institute

    Portland, Oregon, 97213

  • Mayo Clinic - Rochester

    Rochester, Minnesota, 55905

  • Providence Saint John's Health Center

    Santa Monica, California, 90404

  • Mayo Clinic - Phoenix

    Scottsdale, Arizona, 85054

  • University of Washington

    Seattle, Washington, 98109

  • H. Lee Moffitt Cancer Center

    Tampa, Florida, 33612

Other trials in United States

About this study

Official title: Phase 1 Trial of Intravenous Administration of TAEK-VAC-HerBy Vaccine Alone and in Combination With HER2 Antibodies in Patients With Advanced Cancer.

A Phase 1 open label trial of intravenous administration of TAEK-VAC-HerBy vaccine in patients with advanced brachyury and/or HER2- expressing cancer. The study will be completed in 2 stages. In Stage 1 patients will be enrolled and treated according to a 3+3 dose escalation scheme. Up to 4 dose levels will be explored to determine the recommended dose of TAEK-VAC-HerBy for Stage 2 of the trial. Stage 2 will enroll either chordoma patients for treatment with TAEK-VAC-HerBy alone, or HER2- positive breast cancer patients for combination treatment of TAEK-VAC-HerBy vaccine and therapeutic HER2 antibodies (trastuzumab). Patients in both stages will receive TAEK-VAC-HerBy intravenously, every three weeks, three administrations in total.

Being tested
TAEK-VAC-HerBy
Keywords
Brachyury, HER2-expessing cancer
Medical subject headings
Chordoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TAEK-VAC-HerByBiological

    TAEK-VAC-HerBy will be administered intravenously every three weeks with three administrations in total at the dose defined in stage 1. During stage 2, it may also be administered concurrently with a HER2 antibody(ies) (trastuzumab, pertuzumab).

Study groups in NCT04246671
Study groupRoleWhat they receive
Stage 1 dose escalation: TAEK-VAC-HerBy (1x10E7 Inf.U)ExperimentalTAEK-VAC-HerBy will be administered intravenously every three weeks with three administrations in total at the dose level 1x10E7 Inf.U.
Receives: Biological: TAEK-VAC-HerBy
Stage 1 dose escalation: TAEK-VAC-HerBy (1x10E8 Inf.U)ExperimentalTAEK-VAC-HerBy will be administered intravenously every three weeks with three administrations in total at the dose level 1x10E8 Inf.U.
Receives: Biological: TAEK-VAC-HerBy
Stage 1 dose escalation: TAEK-VAC-HerBy (1x10E9 Inf.U)ExperimentalTAEK-VAC-HerBy will be administered intravenously every three weeks with three administrations in total at the dose level 1x10E9 Inf.U.
Receives: Biological: TAEK-VAC-HerBy
Stage 1 dose escalation: TAEK-VAC-HerBy (1x10E10 Inf.U)ExperimentalTAEK-VAC-HerBy will be administered intravenously every three weeks with three administrations in total at the dose level 1x10E10 Inf.U.
Receives: Biological: TAEK-VAC-HerBy
Stage 2: Chordoma Cancer CohortExperimentalTAEK-VAC-HerBy will be administered intravenously every three weeks with three administrations in total at the dose level defined in stage 1.
Receives: Biological: TAEK-VAC-HerBy
Stage 2: HER2-positive Breast Cancer Cohort (Trastuzumab + TAEK-VAC-HerBy)ExperimentalTAEK-VAC-HerBy will be administered intravenously to patients who are on stable dose of trastuzumab, every three weeks with three administrations in total at the dose defined in stage 1.
Receives: Biological: TAEK-VAC-HerBy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Patients with Dose Limiting Toxicity (DLT)

    Frequency of patients with DLTs

    Measured: DLT evaluation period is 30 days after the last vaccine dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Jan 2020
  2. Study start10 Aug 2020
  3. Primary completion17 Feb 2024
  4. Study completion11 Dec 2024

Resources

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
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
37 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04246671
Sponsor's protocol ID
TAEK-VAC-HerBy-001
Status last verified
Feb 2025
First submitted
24 Jan 2020
Last updated
3 Mar 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Wedekind MF, Widemann BC, Cote G. Chordoma: Current status, problems, and future directions. Curr Probl Cancer. 2021 Aug;45(4):100771. doi: 10.1016/j.currproblcancer.2021.100771. Epub 2021 Jul 1.

    PubMed 34266694

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing TAEK-VAC-HerBy in people with Chordoma and HER2-positive Breast Cancer, run by Bavarian Nordic at 9 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Patients with Dose Limiting Toxicity (DLT) (time frame: DLT evaluation period is 30 days after the last vaccine dose). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04246671, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in