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Virus therapy takes on tough melanoma in early trial

NCT ID NCT07086105

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 30 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2025

Expected to finish

Oct 2028

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

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.

  1. The places running it

    3 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Monash Health

    RECRUITING

    Clayton, Victoria, 3168, Australia

  • Tasman Oncology Research

    RECRUITING

    Southport, Queensland, 4215, Australia

  • The Queen Elizabeth Hospital

    RECRUITING

    Adelaide, South Australia, 5011, Australia

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