ClinicalTrials.gg
No longer availableNCT03420430Updated Sep 25, 2024

Expanded Access to Provide GL-ONC1 for the Treatment of Advanced Cancers With No Standard of Care

An expanded access record providing GL-ONC1 in Advanced Stage Cancer (Solid Tumor Disease for 4 Patients) and Acute Myeloid Leukemia (6 Patients), sponsored by Genelux Corporation. No longer available at 1 site in United States. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2024-09-25.

Sponsored by Genelux Corporation · Expanded access

Study type
Expanded access
Access type
Individual patients
Ages
21 Years and older
Sex
All
01

Study summary

GL-ONC1 expanded access is for patients who are ineligible for an ongoing GL-ONC1 clinical trial. Expanded access is intended to treat individual patients with advanced stage cancers, including blood cancer, with no standard of care options for treatment. Potential patients will be evaluated individually depending on GL-ONC1 product supply.

02

Conditions studied

  • Advanced Stage Cancer (Solid Tumor Disease for 4 Patients)
  • Acute Myeloid Leukemia (6 Patients)
03

In context

Leukemia, Myeloid, Acute

3,667 studies on the registry are indexed under Leukemia, Myeloid, Acute; 816 are open to participants now.

Browse Leukemia, Myeloid, Acute studies →

Lead sponsor

Genelux Corporation is the lead sponsor of 5 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years and older
Sexes eligible
All

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Diagnosis of advanced cancers with no standard of care option for treatment.
  • Willing and able to provide written, signed .
  • Use of adequate .
  • Negative pregnancy test.

Exclusion criteria

Exclusion Criteria:

  • Have not recovered from severe adverse events from prior therapy.
  • Major surgery occurred within 28 days prior to treatment.
  • Known immune system disorders such as , or active or C infection.
  • cardiac disease ( Class III or IV).
  • Have received prior therapy with an oncolytic virus of any type.
  • Be receiving antiviral agent active against vaccinia virus (e.g., cidofovir, vaccinia immunoglobulin, imatinib, ST-246).
  • Have known allergy to ovalbumin or other egg products.
  • Have clinically significant dermatological disorders (e.g., eczema, psoriasis, or any unhealed skin wounds or ulcers) as assessed by the treating physician.
Terms in these criteria, in plain language(6)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

NYHA class (heart failure)

The New York Heart Association’s four classes of how much heart failure limits physical activity.

I
No limits: ordinary activity causes no undue tiredness or breathlessness.
II
Slight limits: comfortable at rest, ordinary activity causes symptoms.
III
Marked limits: comfortable at rest, less than ordinary activity causes symptoms.
IV
Symptoms even at rest; any activity makes them worse.

Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.

05

Access details

Study type
Expanded access
Access type
Individual patients

Available treatment

06

Where to request access

1 site
  • Florida Hospital Cancer Institute
    Orlando, Florida 32804, United States
07

References and documents

Related links

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 25, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03420430
Lead sponsor
Genelux Corporation
Responsible party
Sponsor
First posted
Feb 5, 2018
Last update
Sep 25, 2024
View the source record on ClinicalTrials.gov ↗

Requesting access

Expanded access is arranged between your doctor and the company. Ask your care team to contact the provider listed on this record.

No contact was published for this record. The registry link below has the sponsor’s details.

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Discussion

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