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
This trial does not accept healthy volunteersQualifiers
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
Design model
Sequential
Treatments tested in this trial
Adze1.C
DrugConditionally replicative oncolytic adenovirus expressing CD40L, administered by intratumoural injection in dose escalation cohorts.
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: Adze1.C Dose EscalationExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
From Day 1 (first dose) through Week 16 (end of treatment visit)2
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.
Time frame
Week 1 Day 1 to Week 6 Day 1 (5-week DLT evaluation period)Secondary outcomes
1
Recommended Phase 2 Dose (RP2D) determination
RP2D will be determined by the Safety Review Committee (SRC) based on cumulative safety, DLT, and tolerability data from all cohorts.
Time frame
Through Week 162
Detection of viral shedding in bodily fluids
Presence of Adze1.C viral particles will be assessed in serum, saliva, stool, and urine using PCR-based methods.
Time frame
From Day 1 through Week 163
Objective response rate (ORR)
Proportion of participants with complete or partial response, assessed per iRECIST.
Time frame
From first dose through disease progression (estimated up to 6 months)4
Progression-Free Survival (PFS)
Time from first treatment to documented disease progression or death from any cause, per iRECIST.
Time frame
From first dose to disease progression or death (estimated up to 12 months)Sponsors and contacts
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Source ClinicalTrials.gov