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TAEK-VAC-HerBy Vaccine for Brachyury and HER2 Expressing Cancer | Clinical Trials | Clareo Health

COMPLETEDPHASE1

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

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

NCT04246671•Bavarian Nordic

View on ClinicalTrials.gov

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. 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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•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.
•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.
+2 more criteria

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.

Locations (9)

Mayo Clinic - Phoenix

Scottsdale, Arizona, United States

Providence Saint John's Health Center

Santa Monica, California, United States

Mayo Clinic - Jacksonville

Jacksonville, Florida, United States

H. Lee Moffitt Cancer Center

Tampa, Florida, United States

Georgia Cancer Center Augusta University

Augusta, Georgia, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Mayo Clinic - Rochester

Rochester, Minnesota, United States

Providence Cancer Institute

Portland, Oregon, United States

University of Washington

Seattle, Washington, United States

Key Dates

Start Date

August 10, 2020

Primary Completion Date

February 17, 2024

Completion Date

December 11, 2024

Last Updated

March 3, 2025

Enrollment

ACTUAL participants

Conditions

ChordomaHER2-positive Breast Cancer

Interventions

TAEK-VAC-HerBy

BIOLOGICAL

A Phase 2 Neoadjuvant Study of Zanidatamab in Combination With Chemotherapy in Participants With HER2-positive Breast Cancer

NCT07102381

HER2-positive Breast CancerBreast Cancer

View study

RECRUITINGPHASE2

Trial of Pre-operative Neratinib and Endocrine Therapy With Trastuzumab in ER-Positive, HER-2 Positive Breast Cancers

NCT04886531

Breast CancerHER2-positive Breast Cancer+2 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 3, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

A Phase 2 Neoadjuvant Study of Zanidatamab in Combination With Chemotherapy in Participants With HER2-positive Breast Cancer

Trial of Pre-operative Neratinib and Endocrine Therapy With Trastuzumab in ER-Positive, HER-2 Positive Breast Cancers

The Evaluation of PC14586 in Patients With Advanced Solid Tumors Harboring a TP53 Y220C Mutation (PYNNACLE)

A Study of Surgery and Radiotherapy in People With Breast Cancer

Assessing the Efficacy and Safety of Anti-HER2 Therapy in Nigerian Women With HER2+ Breast Cancer Before and After Surgery

Radiation Therapy Followed by Intrathecal Trastuzumab/Pertuzumab in HER2+ Breast Leptomeningeal Disease