A Study of Ad-RTS-hIL-12 With Veledimex in Subjects With Breast Cancer

Inclusion Criteria:

Female, age ≥ 18 years
Histologically-confirmed, locally advanced or metastatic adenocarcinoma of the breast
Achievement of SD or PR after a minimum of 12 weeks of pre-study first- or second-line standard chemotherapy
Presence of at least 2 measurable lesions
Standard treatment interrupted, except if anti-HER2 therapy
All treatment-related or radiation-related toxicities resolved to Grade 1 or lower
Submission of copies of tumor measurements and scans
Life expectancy > 12 weeks
ECOG performance status of 0 to 1
Adequate bone marrow function
Adequate liver function
Adequate renal function
Female subjects and their male partners must agree must agree to use a highly reliable method of birth control
Able to swallow oral medication
Willing to comply with study procedures

Exclusion Criteria:

Metastatic breast cancer patients currently on hormonal therapy as first- or second-line are not permitted
Prior radiation therapy encompassing > 25% of bone marrow
Any congenital or acquired condition leading to compromised ability to generate an immune response

Immunosuppressive therapy

Use of systemic immunosuppressive drugs
Requirement for continual immune suppression
Major surgery within 4 weeks of study treatment
An active, second potentially life-threatening cancer

Presence of brain or subdural metastases

Any signs and/or symptoms of brain metastases must be stable for ≥ 4 weeks
Radiographic stability should be determined by comparing contrast-enhanced CT or MRI scans at screening to scans obtained by the same method at least 4 weeks earlier

Presence or documented history of any of the following autoimmune conditions:

Inflammatory bowel disease
Rheumatoid arthritis, systemic progressive sclerosis (scleroderma), systemic lupus erythematosus, autoimmune vasculitis
Motor neuropathy considered of autoimmune origin
Presence of meningeal carcinomatosis
Use of any medications that induce, inhibit, or are substrates of CYP450 3A4

History or evidence of cardiac disease as indicated by any of the following:

Congestive heart failure greater than NYHA Class II
Unstable angina or new-onset angina (begun within the last 3 months), or myocardial infarction within the 6 months prior to enrollment
Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy
Congenital long QT syndrome or taking drugs known to prolong the QT interval
Current use of any drugs with a known risk of causing torsades de pointes
Evidence or history of thromboembolic, venous, or arterial events within the past 3 months
Evidence or history of bleeding diathesis or coagulopathy
International normalized ratio (INR) and activated partial thromboplastin time (aPTT) > 1.5 x ULN, in subject who is not therapeutically anticoagulated.
History of malabsorption syndrome or other condition that would interfere with enteral absorption
Presence of active clinically serious infection
Diagnosis of infection with HIV or chronic infection with hepatitis B or C
Any other unstable or clinically significant concurrent medical condition
Pregnant or breast-feeding
Use of any investigational, non-United States Food and Drug Administration (US FDA) approved drug
Participation in any other clinical trial
Presence of any condition which makes the patient unsuitable