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

NCT07086105 | Recruiting Phase 1

• 1 other identifier: ADZE1.C-001
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 3

Brief 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. 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.

Conditions

Metastatic Melanoma

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Week 1 Day 1 to Week 6 Day 1 (5-week DLT evaluation period)

Secondary Outcomes (5)

• Recommended Phase 2 Dose (RP2D) determination

  Through Week 16

• Detection of viral shedding in bodily fluids

  From Day 1 through Week 16

• Objective response rate (ORR)

  From first dose through disease progression (estimated up to 6 months)

• Progression-Free Survival (PFS)

  From first dose to disease progression or death (estimated up to 12 months)

• Patient-reported quality of life using EORTC QLQ-C30

  From baseline to Week 16

Study Arms (1)

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.

Drug: Adze1.C

Interventions

Adze1.C DRUG

Conditionally replicative oncolytic adenovirus expressing CD40L, administered by intratumoural injection in dose escalation cohorts.

Adze1.C Dose Escalation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Adze Biotechnology Australia Pty Ltd: lead

Study Sites (3)

Tasman Oncology Research

Southport, Queensland, 4215, Australia

RECRUITING

The Queen Elizabeth Hospital

Adelaide, South Australia, 5011, Australia

RECRUITING

Monash Health

Clayton, Victoria, 3168, Australia

RECRUITING

MeSH Terms

Conditions

Melanoma

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Sidney Hopps

CONTACT

+1.917.743.9401; sidh@adzebiotech.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 18, 2025
• First Posted: July 25, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): October 1, 2028
• Last Updated: July 8, 2026

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

AU (3)