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GL-ONC1 · 3 trials · 3 indications
Evaluation of changes in laboratory tests (hematological, chemistry), immunogenicity and physical examination
The safety of GL-ONC1 will be assessed by the evaluation of the type, frequency, and severity of adverse events (AEs), changes in laboratory tests (haematological, chemistry, urinary), immunogenicity and physical examination
| Name | Type | Description |
|---|---|---|
| GL-ONC1 | BIOLOGICAL | A genetically-engineered vaccinia virus administered via intravenous infusion . Cohorts 1, 2, 3: Frequency: 1x in Week 1; Cohort 4: 1x again 1x in Week 2; Cohort 5: 1x Week 1, 1x Week 2, 1x Week 3, 1x Week 4. |
Inclusion Criteria: * Confirmed diagnosis of histologically or cytologically documented Stage III to IVB primary, non-metastatic head and neck cancer for newly diagnosed patients with no prior disease-related treatment (e.g., chemotherapy, radiation treatment, surgery, etc.). * American Joint Commi...
GL-ONC1 is an investigational oncolytic virus being studied for the treatment of advanced solid tumors, peritoneal carcinomatosis, and cancer of the head and neck. It is a monoclonal antibody modality, though it functions as an oncolytic virus. It is currently in Phase 1 clinical development and is not yet approved by regulatory authorities.
GL-ONC1 is being developed by Genelux Corporation, a biopharmaceutical company. The company's stock ticker is GNLX. Genelux is conducting clinical trials to evaluate the safety and efficacy of GL-ONC1 in various oncology indications.
GL-ONC1 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory agencies such as the FDA. All completed trials for GL-ONC1 are Phase 1 studies, and it remains in early-stage clinical testing.
GL-ONC1 has been studied in three completed Phase 1 clinical trials. These include NCT00794131 for advanced solid tumors in the United Kingdom, NCT01443260 for peritoneal carcinomatosis in Germany, and NCT01584284 for head and neck cancer in the United States. All trials were uncontrolled and not randomized.
GL-ONC1 is an oncolytic virus, specifically an attenuated vaccinia virus, that is designed to selectively infect and destroy cancer cells. While it is classified as a monoclonal antibody modality, its mechanism involves viral oncolysis, where the virus replicates within tumor cells and causes their lysis, potentially stimulating an immune response.
Yes, GL-ONC1 is an oncolytic vaccinia virus. It is an attenuated form of the vaccinia virus that has been modified to target and kill cancer cells. This mechanism is being investigated in clinical trials for multiple solid tumor types, including head and neck cancer and peritoneal carcinomatosis.