NeoplasmsPhase 1NCT01514123
Study of VGX-100 Administered Alone and Co-administered With Bevacizumab in Adult Subjects With Advanced Solid Tumors
A Phase 1 study testing VGX-100 and Bevacizumab in people with Neoplasms and Cancer, run by Circadian Technologies Ltd. at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- VGX-100 and Bevacizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 2 sitesUnited States
- Study dates
- 29 Dec 2011to 16 Nov 2017
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 28Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
UT MD Anderson Cancer Center
Houston, Texas, 77030
UCLA Hematology-Oncology
Santa Monica, California, 90404
About this study
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
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.
- Being tested
- VGX-100, Bevacizumab
- 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
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VGX-100Drug
VGX-100 will be administered by IV infusion once every week
BevacizumabDrug
Also called Avastin
Bevacizumab will be administered by IV infusion once every 2 weeks
| Study group | Role | What they receive |
|---|---|---|
| Arm A - VGX-100 alone | Experimental | Dose escalation of VGX-100 monotherapy Receives: Drug: VGX-100 |
| Arm B - VGX-100 plus bevacizumab | Experimental | Dose escalation of VGX-100 in combination with escalating doses of bevacizumab Receives: Drug: VGX-100; Drug: Bevacizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence and severity of adverse events including dose limiting toxicities
Measured: Approximately 16 months
Secondary outcomes (4)
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
Measured: 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)
Measured: 28 days after the last subject in each cohort
Anti-VGX-100 antibody formation
Measured: Approximately 16 months
Biomarker levels including VEGF-A, VEGF-C, VEGF-D, soluble VEGFR-2, and soluble VEGFR-3
Measured: Approximately 16 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2012 (estimated)
- Study start29 Dec 2011
- Primary completion7 Feb 2014
- Study completion16 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Circadian Technologies Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Research, Study director, Circadian Technologies
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01514123
- Sponsor's protocol ID
- VGX-100-1001
- Status last verified
- Sep 2020
- First submitted
- 12 Jan 2012
- Last updated
- 17 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01514123
- Acronym / sponsor ID
- VGX-100-1001
- Keywords
- VGX-100, Bevacizumab, VEGF-C, First-In-Human, Dose Escalation, Advanced Solid Tumors, Angiogenesis Inhibitors, Angiogenesis Modulating Agents
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Circadian Technologies Ltd.Industry (pharma, biotech, devices)
- Study start
- 29 Dec 2011 (actual)
- Primary completion
- 7 Feb 2014 (actual)
- Study completion
- 16 Nov 2017 (actual)
- First posted
- 20 Jan 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A - VGX-100 alone | Experimental | Drug: VGX-100Dose escalation of VGX-100 monotherapy |
| Arm B - VGX-100 plus bevacizumab | Experimental | Drug: VGX-100, Drug: BevacizumabDose escalation of VGX-100 in combination with escalating doses of bevacizumab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (28 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VGX-100VGX-100 will be administered by IV infusion once every week | Drug | Arm A - VGX-100 alone, Arm B - VGX-100 plus bevacizumab |
| BevacizumabAlso: AvastinBevacizumab will be administered by IV infusion once every 2 weeks | Drug | Arm B - VGX-100 plus bevacizumab |
Primary outcome
The incidence and severity of adverse events including dose limiting toxicities
Time frame: Approximately 16 months
4 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Research study director
Circadian Technologies
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing VGX-100 and Bevacizumab in people with Neoplasms and Cancer, run by Circadian Technologies Ltd. at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence and severity of adverse events including dose limiting toxicities (time frame: Approximately 16 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2020.