TAEK-VAC-HerBy Vaccine for Brachyury and HER2 Expressing Cancer
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT04246671 |
Recruitment Status :
Recruiting
First Posted : January 29, 2020
Last Update Posted : October 31, 2022
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Condition or disease | Intervention/treatment | Phase |
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Chordoma HER2-positive Breast Cancer HER2-positive Gastric/Gastroesophageal Junction Cancer | Biological: TAEK-VAC-HerBy | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 55 participants |
Allocation: | Non-Randomized |
Intervention Model: | Sequential Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
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. |
Actual Study Start Date : | August 10, 2020 |
Estimated Primary Completion Date : | June 2024 |
Estimated Study Completion Date : | June 2026 |
Arm | Intervention/treatment |
---|---|
Experimental: Stage 1 dose escalation: TAEK-VAC-HerBy (1x10E7 Inf.U)
TAEK-VAC-HerBy will be administered intravenously every three weeks with three administrations in total at the dose level 1x10E7 Inf.U.
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Biological: TAEK-VAC-HerBy
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). |
Experimental: Stage 1 dose escalation: TAEK-VAC-HerBy (1x10E8 Inf.U)
TAEK-VAC-HerBy will be administered intravenously every three weeks with three administrations in total at the dose level 1x10E8 Inf.U.
|
Biological: TAEK-VAC-HerBy
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). |
Experimental: Stage 1 dose escalation: TAEK-VAC-HerBy (1x10E9 Inf.U)
TAEK-VAC-HerBy will be administered intravenously every three weeks with three administrations in total at the dose level 1x10E9 Inf.U.
|
Biological: TAEK-VAC-HerBy
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). |
Experimental: Stage 1 dose escalation: TAEK-VAC-HerBy (1x10E10 Inf.U)
TAEK-VAC-HerBy will be administered intravenously every three weeks with three administrations in total at the dose level 1x10E10 Inf.U.
|
Biological: TAEK-VAC-HerBy
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). |
Experimental: Stage 2: Chordoma Cancer Cohort
TAEK-VAC-HerBy will be administered intravenously every three weeks with three administrations in total at the dose level defined in stage 1.
|
Biological: TAEK-VAC-HerBy
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). |
Experimental: Stage 2: HER2-positive Breast Cancer Cohort (Trastuzumab + TAEK-VAC-HerBy)
TAEK-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.
|
Biological: TAEK-VAC-HerBy
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). |
Experimental: Stage 2: HER2-positive Breast Cancer Cohort (Trastuzumab + Pertuzumab + TAEK-VAC-HerBy)
TAEK-VAC-HerBy will be administered intravenously to patients who are on stable dose of trastuzumab and pertuzumab. TAEK-VAC-HerBy will be administered every three weeks with three administrations in total at the dose defined in stage 1.
|
Biological: TAEK-VAC-HerBy
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). |
Experimental: Stage 2: HER2-positive Gastric/GEJ cancer cohort (Trastuzumab + TAEK-VAC-HerBy)
TAEK-VAC-HerBy will be administered intravenously to HER2-positive gastric/GEJ cancer patients who are on stable dose of trastuzumab. TAEK-VAC-HerBy will be administered every three weeks with
|
Biological: TAEK-VAC-HerBy
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). |
- Patients with Dose Limiting Toxicity (DLT) [ Time Frame: DLT evaluation period is 30 days after the last vaccine dose ]Frequency of patients with DLTs

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
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%.
- 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.
- Patients are required to be on active treatment with HER2 antibodies (trastuzumab, pertuzumab) prior to and during study treatment.
- 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.
Exclusion Criteria:
- 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04246671
Contact: Tatiana Adams, MD, PhD | +49 172 840 04 36 | info@bavarian-nordic.com |
United States, Arizona | |
Mayo Clinic - Phoenix | Recruiting |
Scottsdale, Arizona, United States, 85259 | |
Contact mayocliniccancerstudies@mayo.edu | |
United States, California | |
Providence Saint John's Health Center | Recruiting |
Santa Monica, California, United States, 90404 | |
Contact: DeLisa Madere delisa.madere@providence.org | |
United States, Florida | |
Mayo Clinic - Jacksonville | Recruiting |
Jacksonville, Florida, United States, 32224 | |
Contact mayocliniccancerstudies@mayo.edu | |
H. Lee Moffitt Cancer Center | Terminated |
Tampa, Florida, United States, 33612 | |
United States, Georgia | |
Georgia Cancer Center Augusta University | Recruiting |
Augusta, Georgia, United States, 30912 | |
Contact: Latasha McKie LGOMILLIONMCKIE@augusta.edu | |
United States, Massachusetts | |
Massachusetts General Hospital | Recruiting |
Boston, Massachusetts, United States, 02114 | |
Contact: Ashley O'Meara ALOMERA@mgh.harvard.edu | |
United States, Minnesota | |
Mayo Clinic - Rochester | Recruiting |
Rochester, Minnesota, United States, 55905 | |
Contact mayocliniccancerstudies@mayo.edu | |
United States, Oregon | |
Providence Cancer Institute | Recruiting |
Portland, Oregon, United States, 97213 | |
Contact: Providence Cancer Institute CanClinRsrchStudies@providence.org | |
United States, Washington | |
University of Washington | Recruiting |
Seattle, Washington, United States, 98195 | |
Contact: Kris Kauno kkauno@uw.edu |
Principal Investigator: | Mary (Nora) L Disis, MD | University of Washington Medicine Seattle |
Responsible Party: | Bavarian Nordic |
ClinicalTrials.gov Identifier: | NCT04246671 |
Other Study ID Numbers: |
TAEK-VAC-HerBy-001 |
First Posted: | January 29, 2020 Key Record Dates |
Last Update Posted: | October 31, 2022 |
Last Verified: | October 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Brachyury HER2-expessing cancer |
Chordoma Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms |