- HER2 Positive
- Have histological or cytological diagnosis of locally advanced/metastatic HER2 solid
tumors that has progressed or become intolerant to standard therapy or for which no
standard therapy is available
- Have measurable and/or evaluable disease based on RECIST 1.1.
- ECOG performance status of 0 to 1
- Have no major existing comorbidities or medical conditions that will preclude therapy
in the view of the Investigator
- Demonstrate adequate organ function
- Female subjects of childbearing potential should have a negative urine or serum
pregnancy within 72 hours prior to receiving the first dose of study medication,
pregnancy test will be required.
- Female subjects of childbearing potential should be willing to use 2 methods of birth
control or be surgically sterile, or abstain from heterosexual activity for the
course of the study through 90 days after the last dose of study medication
- Male subjects should agree to use an adequate method of contraception starting with
the first dose of study therapy through 90 days after the last dose of study therapy.
- Has Cardiac Functional Capacity >1 based on NY Heart Association criteria
- Is newly diagnosed with a curative treatment option available.
- Has LVEF below normal limits, as defined by institutional standards.
- Has known active central nervous system (CNS) metastases and/or carcinomatous
- Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any
other form of' immunosuppressive therapy within 7 days prior to the first dose of
- Has had a prior monoclonal antibody therapy within 2 weeks prior to study Day 1.
(Prior anti-HER2 therapy is acceptable).
- Has received anticancer chemotherapy, surgical treatment, and/or radiation therapy
(except palliative radiation therapy for disease-related pain with a consult with the
sponsor's medical monitor) within 2 weeks of first study treatment.
- Has a known additional malignancy that is progressing or requires active treatment.
Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the
skin, or in situ cervical cancer that has undergone potentially curative therapy.
- Has an active autoimmune disease requiring systemic treatment within the past 3
months or a documented history of clinically severe autoimmune disease, or a syndrome
that requires systemic steroids or immunosuppressive agents.
- Has a history or current evidence of any condition, therapy, or laboratory
abnormality that might confound the results of the trial, interfere with the
subject's participation for the full duration of the trial, or is not in the best
interest of the subject to participate, in the opinion of the treating Investigator.
- Is pregnant or breastfeeding, or expecting to conceive or father children within the
projected duration of the trial
- Is dependent on antibiotics and/or corticosteroids, except hormone replacement
- Has active infection requiring systemic therapy or is dependent on or currently
receiving antibiotics that cannot be discontinued before dosing
- Is dependent on, currently or has received within the past 4 weeks corticosteroids
(hormone replacement therapy, topical corticosteroids and occasional inhaled
corticosteroids are allowed).
- Has a known allergy to any component of the study drug(s) formulations.
- Previous history of listeriosis or prior HER2 vaccine therapy.
- Has a known history of human immunodeficiency virus (HIV) (HIV 1/2 antibodies).
- Has known active hepatitis B (eg, HBsAg reactive) or hepatitis C (eg, HCV RNA
[qualitative] is detected).
- Has a contraindication to administration of trimethoprim/sulfamethoxazole and
- Has received a live vaccine within 30 days prior to the first dose of trial
- In the opinion of the Investigator, subject has rapidly progressing disease, OR has
life expectancy of less than 6 months, OR would be unable to receive at least one
cycle of therapy.
Minimum Eligible Age: 18 Years
Maximum Eligible Age: N/A
Eligible Gender: Both