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

STATUS

Recruiting
End date

Jan 27, 2026
participants needed

55
sponsor

Bavarian Nordic

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Updated on 27 June 2022

See if I qualify

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 Identifier	NCT04246671
Sponsor	Bavarian Nordic
Last Modified on	27 June 2022

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