Summary
This clinical trial is testing a new experimental treatment called Adze1.C for adults with advanced melanoma.
Adze1.C is a type of oncolytic virus therapy. Oncolytic viruses are specifically designed to infect and destroy cancer cells. They may also help the body's immune system recognise and attack cancer.
The main goals of this Phase 1 trial are to:
- Find the highest dose of Adze1.C that can be given safely
- Learn about the treatment's side effects and how well people tolerate it
- Understand how the treatment works in the body
- Look for early signs that the treatment may help control the cancer
Who can take part?
You may be eligible for this study if you:
- are aged 18 years or older
- have Stage IIIB to IV melanoma
- have melanoma that cannot be removed with surgery (unresectable)
- and/or your cancer has spread to other parts of the body (metastatic)
- are not responding, or not suitable for, standard treatments
Up to 30 participants will take part at several hospitals and cancer centres.
What does participation involve?
Participants will receive Adze1.C as an injection directly into a tumour.
Treatment begins with a low introductory dose. Three weeks later, participants will receive a higher dose, depending on which study group (cohort) they are assigned to.
There are three dose groups: low dose, medium dose, and high dose.
Researchers will gradually increase the dose between groups of participants to help determine the safest dose level.
After the higher dose is given, participants will continue to receive injections every 2 weeks. Doctors will closely monitor participants for side effects and other safety concerns throughout the study.
People who continue to meet the study requirements may be able to stay on treatment for up to 14 weeks.