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

  • STATUS
    Recruiting
  • End date
    Jan 27, 2026
  • participants needed
    55
  • sponsor
    Bavarian Nordic
Updated on 27 June 2022
ct scan
platelet count
renal function
cancer
total bilirubin
tyrosine
absolute neutrophil count
ejection fraction
tumor markers
systemic therapy
estrogen
measurable disease
breast cancer
lapatinib
endocrine therapy
lung cancer
bone marrow procedure
gilbert's syndrome
progesterone
doxorubicin
gilbert's disease
metastasis
neutrophil count
hormone therapy
pertuzumab
liver metastasis
HER2
pd-l1
trastuzumab
primary cancer
cancer chemotherapy
targeted therapy
progesterone receptor
erbb2
estrogen receptor
her2/neu-positive breast cancer
epirubicin
metastatic cancer
mammogram
renal function test
mg++
lung carcinoma

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.

Details
Condition Chordoma, Breast Cancer, Gastric/Gastroesophageal Junction Cancer, Ovarian Cancer, Prostate Cancer, Colorectal Cancer, Pancreatic Cancer, Hepatocellular Cancer, Merkel Cell Cancer, Small Cell Lung Cancer
Treatment TAEK-VAC-HerBy
Clinical Study IdentifierNCT04246671
SponsorBavarian Nordic
Last Modified on27 June 2022

Eligibility

Yes No Not Sure

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
Serum creatinine ≤1.5 x upper limit of normal (ULN) OR creatinine clearance (CrCl) ≥40 mL/min
Patients must have normal organ and bone marrow function as defined below
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
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
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
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

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 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 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
Known history of, or any evidence of active, non-infectious pneumonitis or primary pulmonary fibrosis
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