Overview

This trial is active, not recruiting.

Conditions neoplasms, cancer
Treatments vgx-100, bevacizumab
Phase phase 1
Target VEGF
Sponsor Circadian Technologies Ltd.
Start date January 2012
End date October 2016
Trial size 40 participants
Trial identifier NCT01514123, VGX-100-1001

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 advanced or metastatic solid tumors. The study is aimed at evaluating the safety and establishing the recommended dose of the VEGF-C human monoclonal antibody VGX-100 when administered alone or in combination with bevacizumab.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Dose escalation of VGX-100 monotherapy
vgx-100
VGX-100 will be administered by IV infusion once every week
(Experimental)
Dose escalation of VGX-100 in combination with escalating doses of bevacizumab
vgx-100
VGX-100 will be administered by IV infusion once every week
bevacizumab Avastin
Bevacizumab will be administered by IV infusion once every 2 weeks

Primary Outcomes

Measure
The incidence and severity of adverse events including dose limiting toxicities
time frame: Approximately 16 months

Secondary Outcomes

Measure
Tumor response by RECIST criteria
time frame: Approximately 16 months
Pharmacokinetic parameters of VGX-100 alone and co-administered with bevacizumab including Cmax, Cmin, AUC and if feasible half life (t1/2)
time frame: 28 days after the last subject in each cohort
Anti-VGX-100 antibody formation
time frame: Approximately 16 months
Biomarker levels including VEGF-A, VEGF-C, VEGF-D, soluble VEGFR-2, and soluble VEGFR-3
time frame: Approximately 16 months

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title 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
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by Circadian Technologies Ltd..