A Study to Evaluate Intravenous TAEK-VAC-HerBy Vaccine Alone and in Combination Treatment in patients with advanced cancer


About this study

The primary purposes of this study are to is to assess safety and tolerability of IV administration of TVH vaccine alone and in combination with HER2 antibodies in patients with advanced cancer.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Eligibility last updated 12/14/22. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Ciara O'Sullivan, M.B., B.Ch.

Closed for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015


Jacksonville, Fla.

Mayo Clinic principal investigator

Saranya Chumsri, M.D.

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015


Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Mohamad Sonbol, M.D.

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015


More information


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