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

Genelux

Status

Conditions: Acute Myeloid Leukemia (6 Patients); Advanced Stage Cancer (Solid Tumor Disease for 4 Patients)

Treatments: Biological: GL-ONC1

Study type: Expanded Access

Funder types: Industry

Identifiers

NCT03420430

GL-ONC1-021

Details and patient eligibility

About

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.

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

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 HIV, or active hepatitis B or C infection.
• Clinically significant cardiac disease (New York Heart Association 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.