This is a first-in-human Phase 1b, 2-part, multicenter open-label clinical study to evaluate safety and efficacy of a Nectin-4 radiopharmaceutical (\[225Ac\]Ac-AKY-1189) in patients with locally advanced or metastatic solid tumors and to establish the maximum tolerated dose (MTD) or maximum administered dose (MAD) and the recommended Phase 2 dose.
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Part 1: Number of Patients with Dose-Limiting Toxicities
Timeframe: From enrollment to the end of Cycle 1 (each cycle is 28 days)
Part 1: Occurence of Adverse Events by Severity
Timeframe: Up to the End of Treatment (30 days after the last dose)
Part 2: Objective Response Rate (ORR)
Timeframe: Up to 30 days following last administration