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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

1. Male or female participants aged 18 years or older at Screening. 2. Histologically confirmed unresectable Stage IIIB to IV metastatic melanoma. 3. Refractory to, or unsuitable for, standard treatment options as determined by the investigator. 4. Not a suitable candidate for curative resection. 5. Presence of measurable disease per iRECIST (excluding irradiated lesions unless progression post-radiation is documented). 6. ECOG performance status of 0, 1, or 2 at Screening. 7. Willing and able to provide written informed consent and comply with study procedures.

Exclusion Criteria:

1. 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.

- Psychiatric illness or social conditions that limit compliance.

2. Immunocompromised status or known HIV infection with ongoing antiretroviral therapy. 3. Active or clinically significant liver disease, including:

- Hepatitis B surface antigen (HBsAg) positive.

- Hepatitis C virus RNA positive.

4. History of organ transplantation. 5. Prior treatment with adenovirus therapy. 6. Prior oncolytic virus treatment within 2 months of Screening. 7. Use of systemic immunosuppressants or immune-modifying drugs at Screening or planned during study. 8. Use of cidofovir within 14 days of Adze1.C dosing. 9. Any other condition which, in the investigator's judgment, would make the participant inappropriate for the study.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT07086105
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 1
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Adze Biotechnology Australia Pty Ltd
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Not yet recruiting
Countries	Australia
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Metastatic Melanoma

Additional Details

This Phase 1, multicenter, open-label, dose-escalation study is designed to evaluate the safety, tolerability, pharmacodynamics, and preliminary efficacy of Adze1.C, a conditionally replicative oncolytic adenovirus encoding CD40L, in participants with metastatic melanoma. Up to 30 participants will be enrolled across three sequential dose cohorts. All participants will first receive a low initial (seroconversion) dose of Adze1.C injected directly into their tumour. Three weeks later, they will receive a higher dose based on their assigned cohort: cohort 1: Adze1.C 1 × 10E8 vp.cohort 2: Adze1.C 1 × 10E9 vp.cohort 3: Adze1.C 1 × 10E10 vp.Dose escalation will follow a standard 3+3 design. Participants will be closely monitored for side effects for five weeks after the first injection. Those who tolerate the treatment may receive additional doses every two weeks for up to 14 weeks total.

Arms & Interventions

Arms

Experimental: Adze1.C Dose Escalation

Participants will receive Adze1.C by intratumoural injection. All will begin with a low seroconversion dose (1 million viral particles), followed three weeks later by an escalation dose based on cohort assignment: Cohort 1: 100 million vp Cohort 2: 1 billion vp Cohort 3: 10 billion vp Doses are given every two weeks for up to 14 weeks. Dose escalation follows a 3+3 design to evaluate safety, tolerability, and early signs of efficacy.

Interventions

Drug: - Adze1.C

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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Tasman Oncology Research, Southport 2148928, Queensland 2152274, Australia

Status

Address

Tasman Oncology Research

Southport 2148928, Queensland 2152274, 4215

Site Contact

[email protected]

+1.917.743.9401

The Queen Elizabeth Hospital, Adelaide 2078025, South Australia 2061327, Australia

Status

Address

The Queen Elizabeth Hospital

Adelaide 2078025, South Australia 2061327, 5011

Site Contact

Rachel Roberts-Thomson, A/Prof

[email protected]

+1.917.743.9401

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