Study of VGX-100 Administered Alone and Co-administered With Bevacizumab in Adult Subjects With Advanced Solid Tumors

Inclusion Criteria:

• Age ≥ 18 years
• Provision of written informed consent
• Histologically or cytologically documented advanced or metastatic solid tumor that is refractory to standard treatment, for which no standard therapy is available, or for which the subject refuses standard therapy
• Life expectancy > 3 months in the opinion of the investigator
• ECOG performance status 0 to 1
• Evaluable OR measurable disease by RECIST 1.1 criteria
• Agree to the use of effective contraceptive if either male or female of child bearing potential

Exclusion Criteria:

• Inadequate venous access
• Women who are lactating/breastfeeding
• Women with a positive pregnancy test or who are planning to become pregnant during the duration of the study
• Known to be HIV positive, or have chronic hepatitis B or C
• Major surgical procedure within 6 weeks of Baseline or surgical or other wound that is not fully healed at Baseline
• Untreated or symptomatic brain metastasis, known central nervous system metastasis, or spinal cord compression (except glioblastoma multiforme)
• Mediastinal or cavitated, or lung mass located near, invading or encasing a major blood vessel or airway on imaging
• Squamous cell lung cancer
• History of or known/suspected gastrointestinal perforation
• Hemoptysis of >2.5 mL (half a teaspoon) red blood within 28 days of Screening
• Deep venous thrombosis or history of symptomatic pulmonary thromboembolism within 6 months of Screening
• Gastrointestinal bleeding requiring medical intervention within 28 days of Screening
• Receipt of therapeutic concentrations of warfarin or other anticoagulants within 7 days of Screening
• Receipt of investigational agent(s) for any indication within 28 days of Baseline or 5 half lives, whichever is greater

• Receipt of the following treatments:

  • Traditional cytotoxics, tyrosine kinase inhibitors or other small molecule anti-cancer agents within 21 days
  • Nitrosoureas, mitomycin C, bevacizumab or trastuzumab within 6 weeks
  • Any other therapeutic monoclonal antibodies within 21 days
  • Hormonal therapy (other than gonadal suppression) within 14 days

• Radiotherapy:

  • to >25% bone marrow
  • to brain within 28 days of baseline
  • other than above within 14 days of baseline
• Unstable angina, myocardial infarction, transient ischemic events, or stroke within 24 weeks of Screening
• History of CNS hemorrhage, cerebrovascular hemorrhage, myocardial infarction or reversible posterior leukoencephalopathy syndrome associated with prior anti-VEGF/anti-VEGFR therapy
• Uncontrolled hypertension of ≥ CTCAE Grade 2
• Proteinuria at Baseline of ≥2+ or 1.0g/24 hours
• Prior allergic reaction to a monoclonal antibody