Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:24 AM
Ignite Modification Date:
2025-12-25 @ 3:24 AM
NCT ID:
NCT07086105
Eligibility Criteria:
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 or 1 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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07086105
Study Brief:
Protocol Section:
NCT07086105