Phase
Condition
Metastatic Melanoma
Melanoma
Treatment
Adze1.C
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
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 theinvestigator.
Not a suitable candidate for curative resection.
Presence of measurable disease per iRECIST (excluding irradiated lesions unlessprogression post-radiation is documented).
ECOG performance status of 0 or 1 at Screening.
Willing and able to provide written informed consent and comply with studyprocedures.
Exclusion
Exclusion Criteria:
- 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
Immunocompromised status or known HIV infection with ongoing antiretroviral therapy.
Active or clinically significant liver disease, including:
Hepatitis B surface antigen (HBsAg) positive
Hepatitis C virus RNA positive
History of organ transplantation.
Prior treatment with adenovirus therapy.
Prior oncolytic virus treatment within 2 months of Screening.
Use of systemic immunosuppressants or immune-modifying drugs at Screening or plannedduring study.
Use of cidofovir within 14 days of Adze1.C dosing.
Any other condition which, in the investigator's judgment, would make theparticipant inappropriate for the study.
Study Design
Study Description
Connect with a study center
Tasman Oncology Research
Southport, Queensland 4215
AustraliaSite Not Available
Tasman Oncology Research
Southport 2148928, Queensland 2152274 4215
AustraliaActive - Recruiting
The Queen Elizabeth Hospital
Adelaide, South Australia 5011
AustraliaSite Not Available
The Queen Elizabeth Hospital
Adelaide 2078025, South Australia 2061327 5011
AustraliaSite Not Available
Monash Health
Clayton 2171400, Victoria 2145234 3168
AustraliaSite Not Available

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