A Study to Evaluate Adze1.C in Participants With Metastatic Melanoma
ConditionMetastatic Melanoma
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorAdze Biotechnology Australia Pty Ltd
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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
Trial design
Treatments tested in this trial
- Adze1.C
Treatment groups
30 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov