RecruitingPhase 1NCT07086105

A Study to Evaluate Adze1.C in Participants With Metastatic Melanoma

A Phase 1, Open-Label, Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacodynamics and Preliminary Efficacy of Intratumoural Adze1.C in Participants With Metastatic Melanoma

Sponsor

Adze Biotechnology Australia Pty Ltd

Enrollment

30 participants

Start Date

Oct 1, 2025

Study Type

INTERVENTIONAL

Conditions

Metastatic Melanoma

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 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 determine the safety of Adze1.C, how well it is tolerated, and to identify the highest dose that can be safely given.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new experimental treatment called Adze1.C in people with advanced melanoma (a serious type of skin cancer) that has spread and cannot be surgically removed. This is an early-phase study to assess safety and early signs of effectiveness. **You may be eligible if...** - You are 18 or older - You have been diagnosed with unresectable Stage IIIB to IV metastatic melanoma confirmed by biopsy - Your cancer has not responded to, or you are not a candidate for, standard treatment options - You are in good enough health for treatment (ECOG 0 or 1) - Your cancer has measurable tumor lesions **You may NOT be eligible if...** - You have uncontrolled infections or other serious active illnesses - You have active autoimmune disease - You have had certain prior treatments that disqualify participation - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAdze1.C

Conditionally replicative oncolytic adenovirus expressing CD40L, administered by intratumoural injection in dose escalation cohorts.

Locations(3)

The Queen Elizabeth Hospital

Adelaide, South Australia, Australia

Tasman Oncology Research

Southport, Queensland, Australia

Monash Health

Clayton, Victoria, Australia

View Full Details on ClinicalTrials.gov

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NCT07086105

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