Metastatic MelanomaPhase 1NCT07086105
A Study to Evaluate Adze1.C in Participants With Metastatic Melanoma
A Phase 1 study testing Adze1.C in people with Metastatic Melanoma, run by Adze Biotechnology Australia Pty Ltd at 3 sites in Australia.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Melanoma
- What is being tested?
- Adze1.C
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 3 sitesAustralia
- Study dates
- 1 Oct 2025to 1 Oct 2028
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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
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- 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.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Australia3 sites, 3 recruiting
- Recruiting
The Queen Elizabeth Hospital
Adelaide, South Australia, 5011
Rachel Roberts-Thomson, A/Prof
- Recruiting
Monash Health
Clayton, Victoria, 3168
Muhammad Alamgeer, Dr
- Recruiting
Tasman Oncology Research
Southport, Queensland, 4215
Andrew Hill, Dr
About this study
Official title: 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.
Read the 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.
- Conditions
- Metastatic Melanoma
- Being tested
- Adze1.C
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adze1.CDrug
Conditionally replicative oncolytic adenovirus expressing CD40L, administered by intratumoural injection in dose escalation cohorts.
| Study group | Role | What they receive |
|---|---|---|
| Adze1.C Dose Escalation | Experimental | 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. Receives: Drug: Adze1.C |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and severity of treatment-emergent adverse events (TEAEs)
Safety will be assessed based on the frequency, nature, and severity of TEAEs, graded per CTCAE v5.0.
Measured: From Day 1 (first dose) through Week 16 (end of treatment visit)
Incidence of dose-limiting toxicities (DLTs)
Number of participants who experience DLTs during the 5-week period following the seroconversion and escalation doses, per predefined DLT criteria.
Measured: Week 1 Day 1 to Week 6 Day 1 (5-week DLT evaluation period)
Secondary outcomes (5)
Recommended Phase 2 Dose (RP2D) determination
RP2D will be determined by the Safety Review Committee (SRC) based on cumulative safety, DLT, and tolerability data from all cohorts.
Measured: Through Week 16
Detection of viral shedding in bodily fluids
Presence of Adze1.C viral particles will be assessed in serum, saliva, stool, and urine using PCR-based methods.
Measured: From Day 1 through Week 16
Objective response rate (ORR)
Proportion of participants with complete or partial response, assessed per iRECIST.
Measured: From first dose through disease progression (estimated up to 6 months)
Progression-Free Survival (PFS)
Time from first treatment to documented disease progression or death from any cause, per iRECIST.
Measured: From first dose to disease progression or death (estimated up to 12 months)
Patient-reported quality of life using EORTC QLQ-C30
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).
Measured: From baseline to Week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2025
- Study start1 Oct 2025
- Primary completion1 Oct 2027 (estimated)
- Study completion1 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic MelanomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Adze Biotechnology Australia Pty Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07086105
- Sponsor's protocol ID
- ADZE1.C-001
- Status last verified
- Nov 2025
- First submitted
- 18 Jul 2025
- Last updated
- 8 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07086105
- Acronym / sponsor ID
- ADZE1.C-001
- Conditions
- Metastatic Melanoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Adze Biotechnology Australia Pty LtdIndustry (pharma, biotech, devices)
- Study start
- 1 Oct 2025 (actual)
- Primary completion
- 1 Oct 2027 (estimated)
- Study completion
- 1 Oct 2028 (estimated)
- First posted
- 25 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adze1.C Dose Escalation | Experimental | Drug: Adze1.CParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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).
Key exclusion criteria (18 listed)
- Uncontrolled intercurrent illness, including but not limited to:
- 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:
- History of organ transplantation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Adze1.CConditionally replicative oncolytic adenovirus expressing CD40L, administered by intratumoural injection in dose escalation cohorts. | Drug | Adze1.C Dose Escalation |
Primary outcome
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.
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.
5 secondary outcomes
Recommended Phase 2 Dose (RP2D) determination
Time frame: Through Week 16
Detection of viral shedding in bodily fluids
Time frame: From Day 1 through Week 16
Objective response rate (ORR)
Time frame: 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)
Patient-reported quality of life using EORTC QLQ-C30
Time frame: From baseline to Week 16
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Adze1.C in people with Metastatic Melanoma, run by Adze Biotechnology Australia Pty Ltd at 3 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sidney Hopps (+1.917.743.9401, sidh@adzebiotech.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and severity of treatment-emergent adverse events (TEAEs) (time frame: From Day 1 (first dose) through Week 16 (end of treatment visit)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2026; AzTrials last refreshed its copy on 26 Oct 2026.