Brief Summary
This is Phase I, open label, multi-center clinical trial evaluating an investigational treatment, Adze1.C. Adze1.C is a type of oncolytic virus therapy for adults with advancedat a late stage, far along Melanomaa type of cancer that develops from melanocytes, which are the cells that produce pigment generally in the skin (but can develop in other areas of the body) that have not responded to standard treatments. Oncolytic viruses are designed to infect and destroy cancera disease where abnormal cells split without control and spread to other nearby body tissue and/or organs cellsthe basic structural and functional unit of all living things and have the potential to stimulate the immune system to fight tumors. The purpose of this study is to determine the safety of Adze1.C, how well it is tolerated, and to identify the highest dosethe amount of medication taken that can be safely given.
Intervention / Treatment
- Drug: Adze1.C
Inclusion Criteria
- Male or female participants aged 18 years or older at Screeningtesting for cancer or conditions that can lead to cancer before symptoms appear, also known as cancer screening.
- Histologically confirmed unresectable Stage IIIB to IV metastatic melanoma.
- Refractory to, or unsuitable for, standard treatment options as determined by the investigator.
- Not a suitable candidate for curative resectionsurgical removal of tissue or part/all of an organ.
- Presence of measurable disease per iRECIST (excluding irradiated lesions unless progression post-radiation is documented).
- ECOG performance status of 0 or 1 at Screening.
- Willing and able to provide written informed consenta process in which a patient receives detailed information about a procedure or treatment, including its potential risks, benefits, and alternatives. The patient then has the opportunity to understand the information and voluntarily agree to the procedure or treatment. and comply with study procedures.