Adze1.C for people with metastatic melanoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase 1, open-label, multi-center dose-escalation trial testing intratumoral injections of Adze1.C, a conditionally replicative oncolytic adenovirus that encodes CD40L. Up to 30 adults with unresectable Stage IIIB–IV melanoma will be enrolled across three sequential dose cohorts following a standard 3+3 design, with an initial low 'seroconversion' dose followed three weeks later by a higher cohort-specific dose (1×10^8, 1×10^9, or 1×10^10 viral particles). Participants will be closely monitored for safety and tolerability, with pharmacodynamic and preliminary efficacy measures collected; those who tolerate treatment may receive additional doses every two weeks for up to 14 weeks. The primary goal is to identify the highest safe dose and characterize side effects while collecting early signals of immune activation and tumor response.

Why it matters

Who can join: the full rules

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.

Where it's running

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

Study contacts

• Study coordinator: Sidney Hopps
• Email: sidh@adzebiotech.com
• Phone: +1.917.743.9401

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.