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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


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Neoplasms, Cancer

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Trial Information

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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

The incidence and severity of adverse events including dose limiting toxicities

Outcome Time Frame:

Approximately 16 months

Safety Issue:

Yes

Principal Investigator

Clinical Research

Investigator Role:

Study Director

Investigator Affiliation:

Circadian Technologies

Authority:

United States: Food and Drug Administration

Study ID:

VGX-100-1001

NCT ID:

NCT01514123

Start Date:

January 2012

Completion Date:

April 2013

Related Keywords:

  • Neoplasms
  • Cancer
  • VGX-100
  • Bevacizumab
  • VEGF-C
  • First-In-Human
  • Dose Escalation
  • Advanced Solid Tumors
  • Angiogenesis Inhibitors
  • Angiogenesis Modulating Agents
  • Pharmacologic Actions
  • Antibodies, Monoclonal
  • Phase 1
  • Oncology
  • Advanced malignancy
  • Neoplasms

Name

Location

UT MD Anderson Cancer CenterHouston, Texas  77030
UCLA Hematology-OncologySanta Monica, California  90404