A Phase I, Open Label, Dose Escalation Study of the VEGF-C Human Monoclonal Antibody VGX-100 Administered by Intravenous Infusion Alone and Co-administered With Bevacizumab in Adult Subjects With Advanced or Metastatic 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