Phase 1 study for people with Melanoma

Recruiting Phase 1

Sources: ClinicalTrials.gov Checked: 11 October 2026 Not medical advice

This trial at a glance

Status Recruiting
Phase Phase 1
Sponsor Adze Biotechnology Australia Pty Ltd
Registry number NCT07086105
Started 1 October 2025 Today 16 October 2026 Estimated completion 1 October 2027

Where this trial is running

Trial sites and the status recorded for each
SiteCityState or countryStatus at this site
Tasman Oncology Research Southport QLD Recruiting
The Queen Elizabeth Hospital Adelaide SA Recruiting
Monash Health Clayton VIC Recruiting

voxsanity.com.au · trial sites from public registries · registry record synced 11 October 2026 · not medical advice

Who can join

Age 18 Years and over
Sex Anyone, regardless of sex
Healthy volunteers Not accepted
Enrolment target 30

The official eligibility criteria

Registry text, reproduced exactly. These are the words the trial's sponsor published on ClinicalTrials.gov. They have not been edited, shortened or rewritten, and they are written for researchers rather than for patients.

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.

Dates on the record

Started 1 October 2025
Estimated completion 1 October 2027
Registry last updated 8 July 2026
Checked by Voxsanity 11 October 2026

Results, publications and the official record

Sources and dates

  • ClinicalTrials.gov – the record this page reformats
  • ClinicalTrials.gov processing date: 8 July 2026.
  • This page last checked by Voxsanity: 11 October 2026.

Voxsanity reformats data from public registries into this layout. It does not edit, interpret or add to what the registry published.

Not medical advice.

Individual trial records are refreshed on a rolling basis rather than all at once, so a record may be up to several weeks old. Each trial page and trial card shows the date its own record was last synced. Where a record has lagged, its status, sites and enrolment can differ from the current registry state in either direction, so check the registry link on the trial page before acting on them.

Letter for your doctor

A one-page summary of this trial to print or email to your GP. It carries the registry's own record of the trial and its eligibility criteria, and nothing Voxsanity has written about whether it suits you.