NCT07086105
A Study to Evaluate Adze1.C in Participants With Metastatic Melanoma
Recruiting · Phase 1 · Adze Biotechnology Australia Pty Ltd · registry updated 2026-07-08
Inclusion and exclusion lines below are quoted from ClinicalTrials.gov. No match score is shown, because a score needs a person's age, biomarkers, and treatment dates. Confirm the record with the study team.
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 advanced Melanoma that have not responded to standard treatments. Oncolytic viruses are designed to infect and destroy cancer cells and have the potential to stimulate the immune system to fight tumors. The purpose of this study is to assess preliminary efficacy, determine the safety of Adze1.C, how well it is tolerated, and to identify the highest dose that can be safely given.
Inclusion
- Male or female participants aged 18 years or older at 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 resection.
- Presence of measurable disease per iRECIST (excluding irradiated lesions unless progression post-radiation is documented).
- Presence of at least one injectable melanoma lesion and/or tumor-involved lymph node suitable for intratumoral administration.
Exclusion
- Uncontrolled intercurrent illness, including but not limited to:
- Active systemic infection or fever ≥ 38°C within 5 days prior to Screening
- Symptomatic congestive heart failure
- NYHA Class III or IV heart failure
- Unstable angina or arrhythmia
- Leptomeningeal disease, active uncontrolled or symptomatic brain metastases, CNS haemorrhage, uncontrolled peri-tumoural oedema, or conditions associated with high risk of CNS inflammation