NECTINIUM-2: A Phase 1b, 2 Part, Multicenter, Single Arm, Open Label Study to Evaluate the Safety and Efficacy of a Nectin-4 Radiopharmaceutical ([225Ac]Ac-AKY-1189) in Patients With Previously Treated Locally Advanced or Metastatic Solid Tumors
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 Part 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
• Ability to give informed consent and comply with study requirements
• Patients with CNS metastases are eligible if they have received therapy and are neurologically stable, asymptomatic and not receiving corticosteroids
• Documented disease progression on prior line of therapy for metastatic disease