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

HER2-positive Breast Cancer Clinical Trial

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.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04246671
• Other study ID #: TAEK-VAC-HerBy-001
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: August 10, 2020
• Est. completion date: June 2026

Study information

• Verified date: January 2024
• Source: Bavarian Nordic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 55
• Est. completion date: June 2026
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chordoma
• HER2-positive Breast Cancer

Intervention

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).

Locations

Country	Name	City	State
United States	Georgia Cancer Center Augusta University	Augusta	Georgia
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Mayo Clinic - Jacksonville	Jacksonville	Florida
United States	Providence Cancer Institute	Portland	Oregon
United States	Mayo Clinic - Rochester	Rochester	Minnesota
United States	Providence Saint John's Health Center	Santa Monica	California
United States	Mayo Clinic - Phoenix	Scottsdale	Arizona
United States	University of Washington	Seattle	Washington
United States	H. Lee Moffitt Cancer Center	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Bavarian Nordic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patients with Dose Limiting Toxicity (DLT)	Frequency of patients with DLTs	DLT evaluation period is 30 days after the last vaccine dose