AzTrials
AzTrials

Advanced Cancers (Solid Tumors)Phase 1NCT00794131

Safety Study of GL-ONC1, an Oncolytic Virus, in Patients With Advanced Solid Tumors

A Phase 1 study testing GL-ONC1 in people with Advanced Cancers (Solid Tumors), run by Genelux GmbH at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The main purpose of this study is to determine whether, GL-ONC1, an Oncolytic Virus, can safely be administered intravenously in patients with advanced solid tumors. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Advanced Cancers (Solid Tumors)
What is being tested?
GL-ONC1
Type of treatment
Vaccines
How many people
43 participants
Where
1 siteUnited Kingdom
Study dates
Nov 2008to Nov 2015
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

  • Diagnosis of histologically or cytologically documented, advanced stage, primary or metastatic solid tumors refractory to standard therapy or for which no curative standard therapy exists.
  • Evidence of measurable or evaluable disease.
  • Age must be ≥ 18 years.
  • All acute toxic effects of any prior radiotherapy, chemotherapy, or surgical procedures must have resolved to Common Terminology Criteria for Adverse Events (CTCAE, Version 3.0) Grade ≤ 1. Surgery must have occurred at least 28 days prior to study enrolment.
  • Chemotherapy or radiotherapy (other than small-field palliative radiotherapy), immunotherapy and/or hormonal therapy must have been received > 28 days prior to receiving study drug. Subjects may continue to receive LHRH analogue therapy for prostate cancer in face of rising PSA. Bisphosphonates and anticoagulants are permitted.
  • ECOG Performance Score ≤ 1.
Show all 24Show fewer
  • Life expectancy of at least 3 months.
  • Required baseline laboratory data include:
  • Absolute neutrophil count (ANC) ≥ 1.5 x 10^9 [SI units 10^9/L]
  • Platelets ≥ 100 x 10^9 [SI units 10^9/L]
  • Haemoglobin ≥ 9.0 g/dL [SI units gm/L]
  • Serum creatinine ≤ 1.5 x upper limit of normal (ULN)
  • Bilirubin ≤ 1.5 x ULN
  • AST/ALT ≤ 2.5 x ULN or ≤ 5 x ULN in the presence of liver metastases
  • Ejection fraction of ≥50% by MUGA or ECHO.
  • Signed informed consent indicating that the subject is aware of the neoplastic nature of his or her disease and has been informed of the procedures to be followed, the experimental nature of the therapy, the alternatives and the potential benefits, side effects, risks, and discomforts.
  • Willing and able to comply with scheduled visits, treatment plan, and laboratory tests.
  • Female patients must have a negative pregnancy test within five days prior to treatment.
  • Female patients of childbearing potential who are not surgically sterile or postmenopausal and male patients who are not surgically sterile must agree to use highly effective contraception. Barrier methods for contraception must be applied during the treatment period and up to day 60 after the last virus application. The patient must agree to sign his or her consent on this particular inclusion criterion.
  • Additional Inclusion Criteria Relevant for Cohort 8 and the Phase IB Expansion Cohort:
  • Diagnosis of histologically or cytologically documented, advanced stage solid tumor (e.g., primary or metastatic breast, prostate or colorectal cancer) refractory to standard therapy or for which no curative standard therapy exists.
  • Evidence of measurable or evaluable disease.
  • Disease that can be safely serially biopsied.
  • Circulating tumor cell count > 10 for analyses of tumor cell viral delivery.

Who cannot join

  • Prior therapy with a cytolytic virus of any type.
  • Concurrent therapy with any other investigational anticancer agent.
  • Concurrent vaccines or immunotherapy during, and for 30 days before or after, study therapy.
  • Concurrent antiviral agent active against vaccinia virus (e.g. cidofovir, vaccinia immunoglobulin, imatinib, ST-246) during course of study.
  • Patients vaccinated with vaccinia virus within the past 10 years.
  • Patients with known brain metastases: due to poor prognosis and risk of developing progressive neurological dysfunction that would confound the evaluation of neurological or other adverse events.
Show all 16Show fewer
  • Patients with known allergy to ovalbumin or other egg products.
  • Patients with immune system disorders or who are receiving immunosuppressive therapy or any steroids.
  • Patients with clinically significant dermatological disorders, e.g. eczema or psoriasis, or any unhealed skin wounds or ulcers, as assessed by the principal investigator during the screening and during the study.
  • Patients with fevers, or any systemic infections, including known HIV infection, hepatitis B or C.
  • Prior splenectomy.
  • Previous organ transplant.
  • Pregnant or breast-feeding women.
  • Clinically significant cardiac disease (New York Heart Association, Class III or IV) including pre-existing arrhythmia, uncontrolled angina pectoris or myocardial infarction within one year prior to study entry, or grade 2 or higher compromised left ventricular ejection fraction (as determined by MUGA).
  • Dementia or altered mental status that would prohibit informed consent.
  • Other severe, acute, or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration or may interfere with the interpretation of study results and, in the judgment of the principal investigator, would make the subject inappropriate for this study.

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

  • Royal Marsden Hospital

    Surrey

Other trials in United Kingdom

About this study

Official title: Phase I Study of the Safety, Tolerability,and Tumor-Specific Replication of the Intravenous Administration of Green Fluorescent Protein Encoded Genetically Engineered Attenuated Vaccinia Virus, GL-ONC1, in Patients With Advanced Solid Organ Cancers.

The main purpose of this study is to determine whether, GL-ONC1, an Oncolytic Virus, can safely be administered intravenously in patients with advanced solid tumors.

Read the detailed description

In preclinical studies, GL-ONC1 an oncolytic vaccinia virus, has shown the ability to preferentially locate, colonize and destroy tumor cells. This study seeks to evaluate the safety profile of an attenuated vaccinia virus when administered intravenously to patients with advanced solid tumors. The study also seeks to detect virus delivery to primary and/or metastatic tumors, including evaluation of viral delivery by fluorescence imaging (GFP expression); whether anti-vaccinia virus immune response occurs; and will record evidence of any anti-tumor activity. For Cohorts 8 and Expansion Cohort 1B, CTC counts, virus-encoded marker gene analysis and Dynamic Contrast (DCE-MRI) MRI imaging will be used to evaluate tumor micro-circulation in vivo. These measures will be evaluated for their potential predictive value of survival outcomes, and to evaluate any correlation of such pharmacodynamic and response rate indicators in the GL-ONC1 treatment context.

Being tested
GL-ONC1
Keywords
cancer, vaccinia virus, vaccinia, oncolytic, oncolytic virus, biological, imaging
Medical subject headings
Neoplasms, Vaccinia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GL-ONC1Biological

    a genetically-engineered vaccinia virus (encoding Renilla luciferase-Aequorea green fluorescent protein fusion, β-galactosidase, and β-glucuronidase )

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Determine the safety and tolerability of GL-ONC1, administered intravenously to patients with advanced solid tumors.

    Measured: Every 30 minutes for 2 hours after each administration of GL-ONC1, then daily until discharge and on day 8, then weekly up to day 21, then week 12 and week 24

Secondary outcomes (7)

  1. Detection of virus delivery to primary and/or metastatic tumors by PCR and immunohistochemistry.

    Measured: To be performed where tumor is deemed safely accessible for biopsy (requires patient consent). Timing of post-treatment biopsy may vary to optimise data generated, however, within two weeks of administration is considered suitable.

  2. Evaluation of anti-vaccinia virus immune response (antibody responses)

    Measured: To be done at baseline and weekly for the first 8 weeks for all cohorts. A final test will be performed on day 30 after the last virus application.

  3. Evaluation of viral delivery by fluorescence imaging

    Measured: The timing and frequency of visualization will be dependent on the acquired data but may be pursued once weekly for the length of the observation period.

  4. Determine recommended dose and schedule for future investigation.

    Measured: At the end of the study

  5. Evaluation of anti-tumor activity

    Generally CT scan (conventional or spiral), PET/CT, MRI or clinical examination will be used for patients in Cohorts 1-7, however tumor markers can also be used to assess response. For patients enrolled in Cohort 8 and the Phase IB expansion cohort of this trial, tumor evaluation will also be performed by DCE and DW-MRIs as well as FDG-PET-CT and CT scans. RECIST and modified CHOI criteria for response will be employed in image evaluations.

    Measured: Week 12 and week 24 after each cycle (Cohorts 1-7). Cohort 8, 1B: 15 days (± 3 days),on D 29 (± 3 days) prior to Cycle 2 ;CT: weeks 12, 24

  6. Determine possible predictive value of Circulating Tumor Cell counts and Beta-glucuronidase levels relative to patient survival outcomes.

    Circulating Tumor Cells are present in patients with advanced metastatic solid tumor cancers. Beta-glucomidase analysis will be used to determine expression of the virus encoded marker genes. CTC counts and Beta-glucomidase values together may be a prognostic indicator (measure of survival outcomes) for patients with solid tumors.

    Measured: CTC's: baseline, Cycle 1 Day 8, prior to dosing D 1 of Cycles 2, 3, 4. Beta-glucuronidase analysis: baseline , weekly first 2 cycles, monthly pre-dose for following cycles;.Final test day 30 after last treatment

  7. Assess correlation of CTC number with radiological (imaging) as early pharmacodynamic and response rate indicators for GL-ONC1 treatment.

    For patients in Cohort 8 and a Phase 1B expansion study group who have high circulating blood cell counts and solid tumors that may be safely, serially biopsied, the study seeks to demonstrate the correlation of CTC number with radiological outcomes, including Dynamic Contrast Enhanced (DCE) and Diffusion Weighted (DW) magnetic resonance imaging (MRI) and fluoro-deoxy glucose (FDG)-positron emission tomography (PET)-computed tomography (CT) scan changes as early pharmacodynamic and response rate indicators in the GL-ONC1 treatment context.

    Measured: CTC's: baseline, Cycle 1 Day 8, prior to dosing Day 1 of Cycles 2, 3, 4. Imaging: DCE, DW-MRIs and FDG-PET-CT at baseline, 15 days, on Day 29 prior to administration of Cycle 2; CT scans: weeks 12,24.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Nov 2008 (estimated)
  2. Study startNov 2008
  3. Primary completionNov 2015
  4. Study completionNov 2015

Resources

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
43 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00794131
Sponsor's protocol ID
GL-ONC1-002/MA
Status last verified
Apr 2025
First submitted
18 Nov 2008
Last updated
24 Apr 2025
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing GL-ONC1 in people with Advanced Cancers (Solid Tumors), run by Genelux GmbH at 1 site in United Kingdom.

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 24 inclusion and 16 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 24 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. 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?

Determine the safety and tolerability of GL-ONC1, administered intravenously to patients with advanced solid tumors. (time frame: Every 30 minutes for 2 hours after each administration of GL-ONC1, then daily until discharge and on day 8, then weekly up to day 21, then week 12 and week 24). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00794131.

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 24 Apr 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in