Phase 1-1b Study of 225AcAc-A9-3408 to Assess Safety and Effectiveness in Adults With Unresectable or Metastatic Melanoma

What this Trial Is About

Researchers are studying an investigational drug called 225AcAc-A9-3408 in adults with melanoma that cannot be removed by surgery or has spread to other parts of the body. The study aims to find out the side effects of this drug and identify the highest safe dose. It also examines how well the drug shrinks melanoma tumors and measures how much of the drug reaches normal organs and tumors. Participants receive an intravenous injection of the investigational drug once every 6 weeks, for up to 6 doses. Before treatment, they are given a single intravenous dose of the diagnostic agent 68GaGa-A9T-3202 during screening. The study includes two groups a dose escalation phase to find the recommended dose and a dose expansion phase to further evaluate safety and effectiveness at that dose. During the trial, participants visit the doctors office regularly for checkups, scans, and tests, including PET scans to measure drug uptake and tumor response. Researchers monitor side effects from the first treatment until the end of the study and assess tumor responses up to one year after enrollment. The study also tracks how the drug distributes in the body and its effects on organs. Total participation may last several months depending on the treatment cycles received.

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