Adze1.C for people with metastatic melanoma

A Phase 1, Open-Label, Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacodynamics and Preliminary Efficacy of Intratumoural Adze1.C in Participants With Metastatic Melanoma

This trial will try Adze1.C, a virus-based therapy injected directly into tumors, in adults with metastatic melanoma who have not responded to standard treatments.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Adze Biotechnology Inc (Industry-sponsored)
• Drugs / interventions: radiation
• Locations: 3 sites (Southport, Queensland and 2 other locations)
• Trial ID: NCT07086105 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults (≥18 years) with histologically confirmed unresectable Stage IIIB–IV metastatic melanoma, ECOG 0–1, measurable disease amenable to intratumoral injection, and who are refractory to or unsuitable for standard treatment.

Not a fit: Patients who are immunocompromised, have uncontrolled intercurrent illnesses, poor performance status, or no accessible injectable tumor are unlikely to benefit or be eligible for this treatment.

Why it matters

Potential benefit: If successful, Adze1.C could directly kill injected tumor cells and stimulate anti-tumor immunity, offering a new option for patients whose melanoma no longer responds to standard therapies.

How similar studies have performed: Oncolytic virus therapy has shown clinical benefit in melanoma (for example T‑VEC), but Adze1.C is a novel adenovirus expressing CD40L and its safety and efficacy in humans remain unproven.

Eligibility criteria

Inclusion Criteria:

1. Male or female participants aged 18 years or older at Screening.
2. Histologically confirmed unresectable Stage IIIB to IV metastatic melanoma.
3. Refractory to, or unsuitable for, standard treatment options as determined by the investigator.
4. Not a suitable candidate for curative resection.
5. Presence of measurable disease per iRECIST (excluding irradiated lesions unless progression post-radiation is documented).
6. ECOG performance status of 0 or 1 at Screening.
7. Willing and able to provide written informed consent and comply with study procedures.

Exclusion Criteria:

1. 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
   * Psychiatric illness or social conditions that limit compliance
2. Immunocompromised status or known HIV infection with ongoing antiretroviral therapy.
3. Active or clinically significant liver disease, including:

   * Hepatitis B surface antigen (HBsAg) positive
   * Hepatitis C virus RNA positive
4. History of organ transplantation.
5. Prior treatment with adenovirus therapy.
6. Prior oncolytic virus treatment within 2 months of Screening.
7. Use of systemic immunosuppressants or immune-modifying drugs at Screening or planned during study.
8. Use of cidofovir within 14 days of Adze1.C dosing.
9. Any other condition which, in the investigator's judgment, would make the participant inappropriate for the study.

Where this trial is running

Southport, Queensland and 2 other locations

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

Study contacts

• Study coordinator: Sidney Hopps

Conditions Metastatic Melanoma