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:
2025-12-24 @ 4:46 PM
Ignite Modification Date:
2025-12-24 @ 4:46 PM
NCT ID:
NCT07076550
Eligibility Criteria:
Inclusion Criteria:
* Able to provide written informed consent
* \[68Ga\]Ga-A9T-3202 uptake in at least one measurable lesion (per RECIST v1.1) on PET scan
* Histologically or cytologically confirmed unresectable or metastatic melanoma with disease progression on prior standard of care therapy
* Adequate ECOG performance status
* Adequate baseline organ function within 14 days of first dose of investigational product
* Recovered from side effects of prior anticancer therapy
* Women of childbearing potential (WOCBP) must have a negative pregnancy test and follow adequate birth control method(s) during the treatment period and for at least 6 months after last dose of \[225Ac\]Ac-A9-3408. Sexually active males with partners who are WOCBP must agree to adequate birth control method(s) during the treatment period and for at least 3 months after last dose of \[225Ac\]Ac-A9-3408
Exclusion Criteria:
* Previous treatment with radioactive nuclides except radioactive imaging tracers
* Treatment with another investigational product shortly prior to first dose of \[225Ac\]Ac-A9-3408 with exception of anti-PD-1/PD-L1 agents.
* Concurrent anticancer therapy
* Major surgery within 4 weeks of first dose of investigational product
* Second malignancy within 2 years
* Active, clinically serious infection
* Known infusion reactions to components of the investigational product
* Other clinically serious health conditions including cardiovascular and or severe infectious diseases
* Significant central nervous system metastatic disease
* Pregnant, breastfeeding or unwilling to practice adequate birth control method(s)
* Any condition per the opinion of the investigator that would impact the safety of the subject, protocol adherence or ability to provide informed consent
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07076550
Study Brief:
Protocol Section:
NCT07076550