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.
1 other identifier
interventional
37
1 country
9
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Aug 2020
Longer than P75 for phase_1
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 24, 2020
CompletedFirst Posted
Study publicly available on registry
January 29, 2020
CompletedStudy Start
First participant enrolled
August 10, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 17, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 11, 2024
CompletedMarch 3, 2025
February 1, 2025
3.5 years
January 24, 2020
February 28, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Patients with Dose Limiting Toxicity (DLT)
Frequency of patients with DLTs
DLT evaluation period is 30 days after the last vaccine dose
Study Arms (6)
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.
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.
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.
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.
Stage 2: Chordoma Cancer Cohort
EXPERIMENTALTAEK-VAC-HerBy will be administered intravenously every three weeks with three administrations in total at the dose level defined in stage 1.
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.
Interventions
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).
Eligibility Criteria
You may qualify if:
- 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.
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bavarian Nordiclead
Study Sites (9)
Mayo Clinic - Phoenix
Scottsdale, Arizona, 85054, United States
Providence Saint John's Health Center
Santa Monica, California, 90404, United States
Mayo Clinic - Jacksonville
Jacksonville, Florida, 32224, United States
H. Lee Moffitt Cancer Center
Tampa, Florida, 33612, United States
Georgia Cancer Center Augusta University
Augusta, Georgia, 30912, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Mayo Clinic - Rochester
Rochester, Minnesota, 55905, United States
Providence Cancer Institute
Portland, Oregon, 97213, United States
University of Washington
Seattle, Washington, 98109, United States
Related Publications (1)
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.
PMID: 34266694DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mary (Nora) L Disis, MD
University of Washington Medicine Seattle
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 24, 2020
First Posted
January 29, 2020
Study Start
August 10, 2020
Primary Completion
February 17, 2024
Study Completion
December 11, 2024
Last Updated
March 3, 2025
Record last verified: 2025-02