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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 head and neck cancer. It is a monoclonal antibody modality developed by Genelux Corporation. GL-ONC1 is currently in Phase 1 clinical development and is not yet approved by the FDA.
GL-ONC1 is an oncolytic vaccinia virus that is designed to selectively infect and destroy cancer cells. It does not target a specific molecular target but rather uses the virus's natural ability to replicate in and kill tumor cells while sparing normal tissue. This mechanism is being evaluated in Phase 1 trials.
GL-ONC1 is being developed by Genelux Corporation, a biopharmaceutical company. Genelux is publicly traded under the ticker symbol GNLX. The company is conducting clinical trials to evaluate the safety and efficacy of GL-ONC1 in various cancer indications.
GL-ONC1 is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. All completed trials for GL-ONC1 are Phase 1 studies, and there are no active trials currently enrolling patients.
GL-ONC1 has been studied in three completed Phase 1 clinical trials: NCT00794131 in advanced solid tumors, NCT01443260 in peritoneal carcinomatosis, and NCT01584284 in head and neck cancer. These trials were conducted in the United Kingdom, Germany, and the United States, respectively.
GL-ONC1 is an oncolytic vaccinia virus, a type of oncolytic virus that is engineered to infect and kill cancer cells. It is being developed by Genelux Corporation for the treatment of various cancers. The drug is not the same as other oncolytic viruses, as each has a unique design and mechanism.