Virus therapy takes on tough melanoma in early trial
NCT ID NCT07086105
First seen Jun 27, 2026 · Last updated Jul 09, 2026 · Updated 2 times
Summary
This early-stage study tests a new treatment called Adze1.C, a virus designed to infect and kill cancer cells while also boosting the immune system. It is for adults with advanced melanoma that has not responded to standard therapies. The main goals are to check the treatment's safety, find the best dose, and see how well it works.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 30 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Oct 2025
- Expected to finish
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Oct 2028
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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). * Presence of at least one injectable melanoma lesion and/or tumor-involved lymph node suitable for intratumoral administration. * ECOG performance status of 0 or 1 at Screening. * Stable visceral metastases and stable CNS metastases may be eligible if protocol-defined eligibility requirements are met. * Willing and able to provide written informed consent and comply with study procedures. Exclusion Criteria: * 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 * Leptomeningeal disease, active uncontrolled or symptomatic brain metastases, CNS haemorrhage, uncontrolled peri-tumoural oedema, or conditions associated with high risk of CNS inflammation * Psychiatric illness or social conditions that limit compliance * Visceral metastatic disease that is not clinically and radiographically stable or requires urgent medical intervention. * Immunocompromised status or known HIV infection with ongoing antiretroviral therapy. * Active or clinically significant liver disease, including: * Hepatitis B surface antigen (HBsAg) positive * 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 other immune-modifying drugs must be discontinued 14 days prior to the first dose. * Use of cidofovir within 14 days of Adze1.C dosing. * Any other condition which, in the investigator's judgment, would make the participant inappropriate for the study.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
3 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Monash Health
RECRUITINGClayton, Victoria, 3168, Australia
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Tasman Oncology Research
RECRUITINGSouthport, Queensland, 4215, Australia
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The Queen Elizabeth Hospital
RECRUITINGAdelaide, South Australia, 5011, Australia
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Real-World melanoma care under the microscope
- New antibody aims to preserve immune checkpoint while fighting cancer
- Can a DNA vaccine teach the immune system to hunt melanoma?
- Can an immune booster make chemo hit melanoma harder?
- A quest to find biomarkers that match melanoma patients with the right immunotherapy
- Can a triple immunotherapy attack beat advanced melanoma?