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 : February 21, 2022
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Condition or disease | Intervention/treatment | Phase |
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Chordoma Breast Cancer Gastric/Gastroesophageal Junction Cancer Ovarian Cancer Prostate Cancer Colorectal Cancer Pancreatic Cancer Hepatocellular Cancer Merkel Cell Cancer Small Cell Lung 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 : | January 2024 |
Estimated Study Completion Date : | January 2026 |

Arm | Intervention/treatment |
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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 a metastatic or recurrent locally advanced malignant tumor.
- ECOG performance status 0 or 1
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Patients must have normal organ and bone marrow function as defined below:
- Serum creatinine ≤1.5 x upper limit of normal (ULN) OR creatinine clearance (CrCl) ≥40 mL/min.
- Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) ≤3 x the ULN.
- Total bilirubin ≤1.5 x ULN (in subjects with Gilbert's syndrome a total bilirubin ≤3.0 x ULN).
- Hemoglobin >9 g/dL.
- Platelet count ≥100,000/µL.
- Absolute neutrophil count (ANC) ≥1000/µL.
- 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 prior chemotherapy, targeted therapy, immunotherapy and/or radiation must be completed at least 4 weeks prior to the first planned dose of TVH vaccine
- Patients must have recovered (Grade 1 or baseline) from any clinically significant toxicity associated with prior therapy.
Additional inclusion criteria for Stage 1
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Patient population:
- Patients with metastatic cancer with a high probability of brachyury expression (such as chordoma, breast, ovarian, prostate, colorectal, pancreatic, hepatocellular, Merkel cell, small cell lung cancer etc) and have progressed on at least two lines of systemic therapy.
- Patients with unresectable locally advanced and metastatic breast and gastric/gastroesophageal junction cancer expressing HER2 at levels lower than the threshold required for definition of HER-2 positivity by ASCO/CAP (breast, gastric/GEJ, ovarian, bladder, salivary gland, endometrial, pancreatic and non-small-cell lung cancer, etc). Patients must have progressed on at least two lines of systemic therapy.
- Patients with breast and gastric HER2- positive tumors as per ASCO/CAP must have progressed after receipt of:
- Breast: at least 3 lines of HER2-targeting therapy
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Gastric and gastroesophageal junction cancer: at the time of progression after 2 lines of HER2-targeting therapy.
- Patients must have measurable or evaluable disease. Measurable disease is defined by RECIST 1.1.
Additional inclusion criteria for Stage 2
- Patients must have measurable disease by computed tomography (CT) or magnetic resonance imaging (MRI) per RECIST 1.1.
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Patient population:
- Cohort 2: chordoma patients with extracranial lesions not amenable for surgical resection with curative intent, nor for radical radiation therapy. At least one target lesion not previously irradiated must be present, either metastatic or locoregional recurrence located outside of previously irradiated field.
- Cohorts 3, 4, and 5: patients with HER2-positive tumors (breast, gastric/GEJ).
- Cohort 4 will include patients on treatment with trastuzumab plus pertuzumab with less than CR (non-improving PR or SD) or as a window of opportunity at the first evidence of progression and before initiating the next line of standard treatment.
- HER2 status must be determined as defined by the most recent ASCO/CAP guidelines for breast and gastric/gastroesophageal cancer.
- For Cohorts 3, 4 and 5, patients must be on a stable dose of HER2 antibody(ies). Patient is defined to be on a stable dose of HER2 antibody(ies) if they have completed the chemotherapy component of regimens consisting on the combination of chemotherapy with HER2-targeting antibodies and have continued with the antibody for a minimum of 2 months.
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.
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Subjects should have no known evidence of being immunocompromised as listed below:
- Human immunodeficiency virus (HIV) positivity, chronic hepatitis infection, including B and C
- Active, known or suspected autoimmune disease. Subjects with vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, and psoriasis not requiring systemic treatment are permitted
- Immunosuppressive therapy, post-organ transplant
- 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, Arizona | Recruiting |
Scottsdale, Arizona, United States, 85259 | |
Contact mayocliniccancerstudies@mayo.edu | |
Principal Investigator: Mohamad Sonbol, MD | |
United States, Florida | |
Mayo Clinic - Jacksonville, Florida | Recruiting |
Jacksonville, Florida, United States, 32224 | |
Contact mayocliniccancerstudies@mayo.edu | |
Principal Investigator: Saranya Chumsri, MD | |
H. Lee Moffitt Cancer Center | Recruiting |
Tampa, Florida, United States, 33612 | |
Contact: Aiana Cerezo, BS 813-745-6985 aiana.cerezo@moffitt.org | |
Principal Investigator: Ricardo Costa, MD | |
United States, Georgia | |
Georgia Cancer Center August University | Recruiting |
Augusta, Georgia, United States, 30912 | |
Contact: Latasha McKie 706-721-4249 LGOMILLIONMCKIE@augusta.edu | |
Principal Investigator: Priyanka Raval, MD | |
United States, Minnesota | |
Mayo Clinic - Rochester, Minnesota | Recruiting |
Rochester, Minnesota, United States, 55905 | |
Contact mayocliniccancerstudies@mayo.edu | |
Principal Investigator: Ciara O'Sullivan, MD | |
United States, Oregon | |
Providence Cancer Institute | Recruiting |
Portland, Oregon, United States, 97213 | |
Contact: Providence Cancer Institute 503-215-2614 CanClinRsrchStudies@providence.org | |
Principal Investigator: David Page, MD | |
United States, Washington | |
University of Washington | Recruiting |
Seattle, Washington, United States, 98195 | |
Contact: Kris Kauno 206-543-3829 kkauno@uw.edu | |
Principal Investigator: Mary (Nora) Disis, MD |
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: | February 21, 2022 |
Last Verified: | February 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 |
Carcinoma, Merkel Cell Small Cell Lung Carcinoma Liver Neoplasms Carcinoma, Hepatocellular Chordoma Neoplasms by Site Neoplasms Digestive System Neoplasms Digestive System Diseases Carcinoma, Bronchogenic Bronchial Neoplasms Lung Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Lung Diseases |
Respiratory Tract Diseases Liver Diseases Adenocarcinoma Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms, Germ Cell and Embryonal Polyomavirus Infections DNA Virus Infections Virus Diseases Infections Tumor Virus Infections Carcinoma, Neuroendocrine Neuroendocrine Tumors Neuroectodermal Tumors |