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RECRUITING
NCT07086105
PHASE1

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

Sponsor: Adze Biotechnology Australia Pty Ltd

View on ClinicalTrials.gov

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

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

30

Start Date

2025-10-01

Completion Date

2027-07-01

Last Updated

2025-11-21

Healthy Volunteers

No

Interventions

DRUG

Adze1.C

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

Locations (3)

Tasman Oncology Research

Southport, Queensland, Australia

The Queen Elizabeth Hospital

Adelaide, South Australia, Australia

Monash Health

Clayton, Victoria, Australia