Status:
COMPLETED
Study of VGX-100 Administered Alone and Co-administered With Bevacizumab in Adult Subjects With Advanced Solid Tumors
Lead Sponsor:
Circadian Technologies Ltd.
Conditions:
Neoplasms
Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This is a non-randomized, multi-dose, first-in-human, multicenter, two arm (Arm A: VGX-100 alone; Arm B: VGX-100 co-administered with bevacizumab), open label, dose escalation study in subjects with a...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 29 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 16 2017
Estimated Enrollment :
43 Patients enrolled
Trial Details
Trial ID
NCT01514123
Start Date
December 29 2011
End Date
November 16 2017
Last Update
September 17 2020
Active Locations (2)
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1
UCLA Hematology-Oncology
Santa Monica, California, United States, 90404
2
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030