Clinical Trials

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.