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.
Histologic or cytologic confirmation of locally advance or metastatic disease
Radiologic confirmation on CT of at least one measurable tumor lesion per RECIST v1.1
ECOG Performance Status of 0 or 1
Adequate end-organ function
Prior treatment with a therapeutic radiopharmaceutical
Prior treatment with a Nectin-4 targeted therapy, except enfortumab vedotin
Received an investigational agent within the previous 28days
Prior treatment with a cytotoxic chemotherapy, targeted therapy, biologic agent, immunotherapy or external-beam radiotherapy in the 3 weeks prior to study treatment