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

Sponsor
Adze Biotechnology Australia Pty Ltd
Study ID
NCT07086105
Phase
PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Adze1.C — DRUG
    Conditionally replicative oncolytic adenovirus expressing CD40L, administered by intratumoural injection in dose escalation cohorts.

Study Details

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.

Key Dates

First listed
Jul 25, 2025
Start date
Oct 1, 2025
Status verified
Nov 2025
Primary completion
Oct 1, 2027
Completion
Oct 1, 2028

Study Design

Enrollment
30 participants (estimated)
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • 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.

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) ]

Central Contacts

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