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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
43
VGX-100 will be administered by IV infusion once every week
Bevacizumab will be administered by IV infusion once every 2 weeks
UCLA Hematology-Oncology
Santa Monica, California, United States
UT MD Anderson Cancer Center
Houston, Texas, United States
The incidence and severity of adverse events including dose limiting toxicities
Time frame: Approximately 16 months
Tumor response by RECIST criteria
Tumor response assessment will be measured by computated tomography (CT) or Magnetic resonance imaging (MRI) every 8 or 12 weeks throughout the study
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
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.