Study of VGX-100 Administered Alone and Co-administered With Bevacizumab in Adult Subjects With Advanced Solid Tumors

Part of paid clinical trials in Santa Monica, California.

Sponsor
Circadian Technologies Ltd.
Study ID
NCT01514123
Phase
PHASE1
Status
Completed

Conditions

  • Cancer
  • Neoplasms

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • VGX-100 — DRUG
    VGX-100 will be administered by IV infusion once every week
  • Bevacizumab — DRUG
    Bevacizumab will be administered by IV infusion once every 2 weeks

Study Details

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.

Key Dates

First listed
Jan 20, 2012
Start date
Dec 29, 2011
Status verified
Sep 2020
Primary completion
Feb 7, 2014
Completion
Nov 16, 2017

Study Design

Enrollment
43 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm A - VGX-100 alone
    Dose escalation of VGX-100 monotherapy
  • Experimental: Arm B - VGX-100 plus bevacizumab
    Dose escalation of VGX-100 in combination with escalating doses of bevacizumab

Primary Outcome Measure

The incidence and severity of adverse events including dose limiting toxicities [ Time Frame: Approximately 16 months ]

Locations (2)

FacilityCityStateZIPSite coordinators
UCLA Hematology-OncologySanta MonicaCalifornia90404-
UT MD Anderson Cancer CenterHoustonTexas77030-

Find similar trials in Santa Monica, CA

By research site
UCLA Hematology-Oncology· Santa Monica, CAUT MD Anderson Cancer Center· Houston, TX

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