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A Study to Evaluate Adze1.C in Participants With Metastatic Melanoma
Sponsor: Adze Biotechnology Australia Pty Ltd
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.
Official title: 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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
30
Start Date
2025-10-01
Completion Date
2027-07-01
Last Updated
2025-11-21
Healthy Volunteers
No
Conditions
Interventions
Adze1.C
Conditionally replicative oncolytic adenovirus expressing CD40L, administered by intratumoural injection in dose escalation cohorts.
Locations (3)
Tasman Oncology Research
Southport, Queensland, Australia
The Queen Elizabeth Hospital
Adelaide, South Australia, Australia
Monash Health
Clayton, Victoria, Australia