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

NCT01514123 | Completed Phase 1

• 1 other identifier: VGX-100-1001
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 2

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 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.

Conditions

Neoplasms; Cancer

Keywords

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

Outcome Measures

Primary Outcomes (1)

• The incidence and severity of adverse events including dose limiting toxicities

  Approximately 16 months

Secondary Outcomes (4)

• Tumor response by RECIST criteria

  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)

  28 days after the last subject in each cohort

• Anti-VGX-100 antibody formation

  Approximately 16 months

• Biomarker levels including VEGF-A, VEGF-C, VEGF-D, soluble VEGFR-2, and soluble VEGFR-3

  Approximately 16 months

Study Arms (2)

Arm A - VGX-100 alone

EXPERIMENTAL

Dose escalation of VGX-100 monotherapy

Drug: VGX-100

Arm B - VGX-100 plus bevacizumab

EXPERIMENTAL

Dose escalation of VGX-100 in combination with escalating doses of bevacizumab

Drug: VGX-100; Drug: Bevacizumab

Interventions

VGX-100 DRUG

VGX-100 will be administered by IV infusion once every week

Arm A - VGX-100 alone; Arm B - VGX-100 plus bevacizumab

Bevacizumab DRUG

Bevacizumab will be administered by IV infusion once every 2 weeks

Also known as: Avastin

Arm B - VGX-100 plus bevacizumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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:

Sponsors & Collaborators

• Circadian Technologies Ltd.: lead

Study Sites (2)

UCLA Hematology-Oncology

Santa Monica, California, 90404, United States

Location

UT MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Neoplasms

Interventions

Bevacizumab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Clinical Research

  Circadian Technologies

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 12, 2012
• First Posted: January 20, 2012
• Study Start: December 29, 2011
• Primary Completion: February 7, 2014
• Study Completion: November 16, 2017
• Last Updated: September 17, 2020

Record last verified: 2020-09

Locations

US (2)