A Phase 1-1b Study to Evaluate the Safety, Efficacy and Dosimetry of Study Drug A9-3408 in Subjects With Metastatic Melanoma

Launched by ALPHA-9 ONCOLOGY USA INC. · Jul 11, 2025

Keywords

ClinConnect Summary

This clinical trial is testing a new drug called A9-3408 to see if it is safe and effective for adults with melanoma, a type of skin cancer, that has spread to other parts of the body or cannot be removed by surgery. The study aims to find out what side effects the drug may cause and the highest safe dose that can be given. Participants will receive the drug once every six weeks, up to six times, and will have regular visits to the doctor for checkups and tests to monitor their health and how well the treatment is working.

To join this trial, adults who have a confirmed diagnosis of melanoma that has progressed despite previous treatments may be eligible. They need to have a certain type of tumor visible on a special scan, be in generally good health, and have recovered from any side effects of earlier cancer treatments. Women who could become pregnant and sexually active men must agree to use birth control during the study and for some time afterward. People who have had recent major surgery, serious infections, or other serious health problems may not be able to participate. This study is not yet recruiting patients but aims to gather important information about this new treatment option for advanced melanoma.

Gender

ALL

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