Actively Recruiting
A Study to Evaluate Adze1.C in Participants With Metastatic Melanoma
Led by Adze Biotechnology Australia Pty Ltd · Updated on 2025-11-21
30
Participants Needed
3
Research Sites
91 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study to Evaluate Adze1.C in Participants With Metastatic Melanoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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)
- ECOG performance status of 0 or 1 at Screening
- Willing and able to provide written informed consent and comply with study procedures
You will not qualify if you...
- 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
- Psychiatric illness or social conditions limiting compliance
- Immunocompromised status or known HIV infection with ongoing antiretroviral therapy
- Active or clinically significant liver disease, including positive Hepatitis B surface antigen or Hepatitis C virus RNA
- History of organ transplantation
- Prior treatment with adenovirus therapy
- Prior oncolytic virus treatment within 2 months of Screening
- Use of systemic immunosuppressants or immune-modifying drugs at Screening or planned during study
- Use of cidofovir within 14 days of Adze1.C dosing
- Any other condition judged by investigator to make participation inappropriate
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
Tasman Oncology Research
Southport, Queensland, Australia, 4215
Actively Recruiting
2
The Queen Elizabeth Hospital
Adelaide, South Australia, Australia, 5011
Not Yet Recruiting
3
Monash Health
Clayton, Victoria, Australia, 3168
Not Yet Recruiting
Research Team
S
Sidney Hopps
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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