Phase 1 Melanoma Trial, Recruiting NCT07086105 Sponsor: Adze Biotechnology Australia Pty Ltd Condition: Melanoma
Back to Melanoma

Phase 1 Melanoma Trial, Recruiting

NCT07086105
Recruiting Phase 1 🇦🇺 Australian site

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • People aged 18 years or older at the time of screening
  • People who have been diagnosed with advanced or spreading melanoma (Stage IIIB to Stage IV) that has been confirmed by laboratory tissue testing and cannot be surgically removed
  • People whose melanoma has not responded to standard treatments, or for whom standard treatments are not appropriate, as determined by the treating doctor
  • People whose cancer cannot be completely removed by surgery with the aim of cure
  • People who have at least one area of cancer that can be measured on scans (not including areas that have been previously treated with radiation, unless the cancer has since grown back in that area)
  • People who have at least one melanoma lesion or cancer-affected lymph node that a doctor can access to inject medication directly into
  • People with a physical functioning level rated as 0 or 1 on the ECOG scale, meaning they are fully active or able to carry out light work (confirm with trial site)
  • People with stable cancer spread to internal organs or the brain may be considered eligible if certain additional protocol requirements are met (confirm with trial site)
  • People who are willing and able to give written consent and follow the study procedures

Who may not be able to join:

  • People with a serious uncontrolled illness, including: an active infection or a fever of 38°C or higher in the 5 days before screening; heart failure causing symptoms; severe heart failure classified as NYHA Class III or IV; unstable chest pain or irregular heartbeat; cancer spread to the fluid around the brain and spinal cord; active or uncontrolled brain metastases causing symptoms; bleeding in the brain; uncontrolled brain swelling around a tumour; or conditions that carry a high risk of brain inflammation
  • People with a mental health condition or personal circumstances that would make it difficult to follow the study requirements
  • People whose cancer has spread to internal organs in a way that is not stable or that needs urgent medical treatment
  • People with a weakened immune system, or people living with HIV who are currently receiving antiviral treatment
  • People with active or significant liver disease, including those who test positive for Hepatitis B surface antigen or have detectable Hepatitis C virus in their blood
  • People who have previously had an organ transplant
  • People who have previously received a type of treatment using adenovirus therapy (confirm with trial site)
  • People who have received any oncolytic virus treatment within 2 months before screening (confirm with trial site)
  • People who have taken medications that suppress or modify the immune system, unless those medications have been stopped at least 14 days before the first dose
  • People who have used a medication called cidofovir within 14 days before receiving the study drug
  • People who, in the treating doctor's judgement, would not be appropriate for the study for any other reason

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 12 July 2026
Phase 1: approximately ~10% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Phone: +1.917.743.9401

Australian sites

Tasman Oncology Research, Southport, Queensland
The Queen Elizabeth Hospital, Adelaide, South Australia
Monash Health, Clayton, Victoria

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 1
Sponsor
Adze Biotechnology Australia Pty Ltd
Registry
ClinicalTrials.gov
Start date
1 October 2025
Est. completion
1 October 2027

Where this trial is recruiting

🇦🇺 Australia

3 site(s) in Australia. Confirm current status and contact details directly with the trial site.

Primary endpoints

Incidence and severity of treatment-emergent adverse events (TEAEs); Incidence of dose-limiting toxicities (DLTs)

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 12 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov