Actively Recruiting
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
Led by Adze Biotechnology Australia Pty Ltd · Updated on 2025-11-21
30
Participants Needed
3
Research Sites
30 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying an investigational treatment called Adze1.C, a type of oncolytic virus therapy, in adults with advanced metastatic melanoma who have not responded to standard treatments. This Phase 1 clinical trial aims to assess the safety, tolerability, and the highest safe dose of Adze1.C. Oncolytic viruses like Adze1.C are designed to infect and destroy cancer cells and may also stimulate the immune system to fight tumors. Participants will receive Adze1.C through direct injections into their tumors. Initially, all participants get a low seroconversion dose, followed three weeks later by a higher dose based on their assigned group: 100 million, 1 billion, or 10 billion viral particles. Doses are given every two weeks for up to 14 weeks. The study follows a dose-escalation design to carefully monitor safety and early signs of treatment response. During the study, up to 30 participants will be closely observed for side effects for five weeks after the first dose. Assessments include safety checks, laboratory tests, and monitoring for viral shedding. The research team will measure the frequency and severity of side effects, dose-limiting toxicities, and treatment response over several months. Quality of life questionnaires will also be completed. The total participation period includes treatment and follow-up visits lasting about 16 weeks or longer for some measures.
CONDITIONS
Brief 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...
- Uncontrolled intercurrent illness including 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 Hepatitis B surface antigen positive or Hepatitis C virus RNA positive
- 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 condition making the participant inappropriate for the study as judged by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 3 weeks
Participants receive a low initial (seroconversion) dose of Adze1.C injected directly into their tumour.
1 visit for initial injection and monitoring during these 3 weeks
Duration - Up to 14 weeks
Participants receive higher doses of Adze1.C based on their assigned cohort by intratumoural injection every two weeks. Dose escalation follows a safety evaluation design. Treatment continues for up to 14 weeks total.
Biweekly visits for injections and monitoring
Duration - Up to 5 weeks after first injection with ongoing assessments through Week 16
Participants are closely monitored for side effects and treatment response after the first injection and throughout the treatment period.
Approximately weekly visits for safety and response monitoring
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
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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