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

January 23, 2024 updated by: Bavarian Nordic

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 and gastric/gastroesophageal junction cancer patients for combination treatment of TAEK-VAC-HerBy vaccine and therapeutic HER2 antibodies (trastuzumab, pertuzumab). Patients in both stages will receive TAEK-VAC-HerBy intravenously, every three weeks, three administrations in total.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

55

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Arizona
      • Scottsdale, Arizona, United States, 85259
        • Mayo Clinic - Phoenix
    • California
      • Santa Monica, California, United States, 90404
        • Providence Saint John's Health Center
    • Florida
      • Jacksonville, Florida, United States, 32224
        • Mayo Clinic - Jacksonville
      • Tampa, Florida, United States, 33612
        • H. Lee Moffitt Cancer Center
    • Georgia
      • Augusta, Georgia, United States, 30912
        • Georgia Cancer Center Augusta University
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic - Rochester
    • Oregon
      • Portland, Oregon, United States, 97213
        • Providence Cancer Institute
    • Washington
      • Seattle, Washington, United States, 98195
        • University of Washington

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patients with Dose Limiting Toxicity (DLT)
Time Frame: DLT evaluation period is 30 days after the last vaccine dose
Frequency of patients with DLTs
DLT evaluation period is 30 days after the last vaccine dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bavarian Nordic

Investigators

  • Principal Investigator: Mary (Nora) L Disis, MD, University of Washington Medicine Seattle

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 10, 2020

Primary Completion (Estimated)

June 1, 2024

Study Completion (Estimated)

June 1, 2026

Study Registration Dates

First Submitted

January 24, 2020

First Submitted That Met QC Criteria

January 28, 2020

First Posted (Actual)

January 29, 2020

Study Record Updates

Last Update Posted (Estimated)

January 24, 2024

Last Update Submitted That Met QC Criteria

January 23, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TAEK-VAC-HerBy-001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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