A Study to Evaluate Adze1.C in Participants With Metastatic Melanoma

July 6, 2026 updated by: Adze Biotechnology Australia Pty Ltd

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 is Phase I, open label, multi-center clinical trial evaluating an investigational treatment, Adze1.C. Adze1.C is a type of oncolytic virus therapy for adults with advanced Melanoma that have not responded to standard treatments. Oncolytic viruses are designed to infect and destroy cancer cells and have the potential to stimulate the immune system to fight tumors. The purpose of this study is to assess preliminary efficacy, determine the safety of Adze1.C, how well it is tolerated, and to identify the highest dose that can be safely given.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This Phase 1, multicenter, open-label, dose-escalation study is designed to evaluate the safety, tolerability, pharmacodynamics, and preliminary efficacy of Adze1.C, a conditionally replicative oncolytic adenovirus encoding CD40L, in participants with metastatic melanoma.

Up to 30 participants will be enrolled across three sequential dose cohorts. All participants will first receive a low initial (seroconversion) dose of Adze1.C injected directly into their tumour. Three weeks later, they will receive a higher dose based on their assigned cohort:

cohort 1: Adze1.C 1 × 10E8 vp

cohort 2: Adze1.C 1 × 10E9 vp

cohort 3: Adze1.C 1 × 10E10 vp

The study will use a stepwise dose-escalation approach (3+3 design) to evaluate safety. Participants will receive injections every 2 weeks and will be monitored closely for side effects throughout the study. Safety during the first 5 weeks after starting treatment will be used to help determine whether the dose can be increased for future participants. Participants who remain eligible may continue receiving treatment for up to 14 weeks.

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Australia
    • Queensland
      • Southport, Queensland, Australia, 4215
        • Recruiting
        • Tasman Oncology Research
        • Principal Investigator:
          • Andrew Hill, Dr
    • South Australia
      • Adelaide, South Australia, Australia, 5011
        • Recruiting
        • The Queen Elizabeth Hospital
        • Contact:
          • Rachel Roberts-Thomson, A/Prof
    • Victoria
      • Clayton, Victoria, Australia, 3168
        • Recruiting
        • Monash Health
        • Principal Investigator:
          • Muhammad Alamgeer, Dr

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Adze1.C Dose Escalation

Participants will receive Adze1.C by intratumoural injection. All will begin with a low seroconversion dose (1 million viral particles (vp)), followed three weeks later by an escalation dose based on cohort assignment:

Cohort 1: 100 million vp Cohort 2: 1 billion vp Cohort 3: 10 billion vp

Doses are given every two weeks for up to 14 weeks. Dose escalation follows a 3+3 design to evaluate safety, tolerability, and early signs of efficacy.
Drug: Adze1.C
Conditionally replicative oncolytic adenovirus expressing CD40L, administered by intratumoural injection in dose escalation cohorts.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence and severity of treatment-emergent adverse events (TEAEs)
Time Frame: From Day 1 (first dose) through Week 16 (end of treatment visit)
Safety will be assessed based on the frequency, nature, and severity of TEAEs, graded per CTCAE v5.0.
From Day 1 (first dose) through Week 16 (end of treatment visit)
Incidence of dose-limiting toxicities (DLTs)
Time Frame: Week 1 Day 1 to Week 6 Day 1 (5-week DLT evaluation period)
Number of participants who experience DLTs during the 5-week period following the seroconversion and escalation doses, per predefined DLT criteria.
Week 1 Day 1 to Week 6 Day 1 (5-week DLT evaluation period)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recommended Phase 2 Dose (RP2D) determination
Time Frame: Through Week 16
RP2D will be determined by the Safety Review Committee (SRC) based on cumulative safety, DLT, and tolerability data from all cohorts.
Through Week 16
Detection of viral shedding in bodily fluids
Time Frame: From Day 1 through Week 16
Presence of Adze1.C viral particles will be assessed in serum, saliva, stool, and urine using PCR-based methods.
From Day 1 through Week 16
Objective response rate (ORR)
Time Frame: From first dose through disease progression (estimated up to 6 months)
Proportion of participants with complete or partial response, assessed per iRECIST.
From first dose through disease progression (estimated up to 6 months)
Progression-Free Survival (PFS)
Time Frame: From first dose to disease progression or death (estimated up to 12 months)
Time from first treatment to documented disease progression or death from any cause, per iRECIST.
From first dose to disease progression or death (estimated up to 12 months)
Patient-reported quality of life using EORTC QLQ-C30
Time Frame: From baseline to Week 16
The EORTC QLQ-C30 is a widely used and validated 30-item questionnaire used to assess quality of life (QoL) in cancer patients. Scores are transformed to a 0-100 scale. For functional scales and global health status/QoL, higher scores indicate better functioning or quality of life. For symptom scales/items, higher scores reflect greater symptom burden (i.e., worse outcome).
From baseline to Week 16

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Adze Biotechnology Australia Pty Ltd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2025

Primary Completion (Estimated)

October 1, 2027

Study Completion (Estimated)

October 1, 2028

Study Registration Dates

First Submitted

July 18, 2025

First Submitted That Met QC Criteria

July 18, 2025

First Posted (Actual)

July 25, 2025

Study Record Updates

Last Update Posted (Actual)

July 8, 2026

Last Update Submitted That Met QC Criteria

July 6, 2026

Last Verified

November 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ADZE1.C-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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