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

Inclusion Criteria

• •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.
• •HER-2 positive cancer: Patients are required to be on active treatment with HER2 antibodies (trastuzumab) prior to and during study treatment.
• •Chordoma patients with progressive extracranial chordoma (base of skull is permitted) not amenable for surgical resection with curative intent, nor for radiation therapy will be enrolled.
• •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.