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

Adze Biotechnology Australia Pty Ltd

Status and phase: Begins enrollment this month; Phase 1

Conditions: Metastatic Melanoma

Treatments: Drug: Adze1.C

Study type: Interventional

Funder types: Industry

Identifiers

NCT07086105

ADZE1.C-001

Details and patient eligibility

About

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 determine the safety of Adze1.C, how well it is tolerated, and to identify the highest dose that can be safely given.

Full 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

Dose escalation will follow a standard 3+3 design. Participants will be closely monitored for side effects for five weeks after the first injection. Those who tolerate the treatment may receive additional doses every two weeks for up to 14 weeks total.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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, 1, or 2 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Sequential Assignment

Masking: None (Open label)

---

30 participants in 1 patient group

Adze1.C Dose Escalation

Experimental group

Description:

Participants will receive Adze1.C by intratumoural injection. All will begin with a low seroconversion dose (1 million viral particles), 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.

Treatment:

Drug: Adze1.C