Overview

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.

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• Prior treatment with a therapeutic radiopharmaceutial
• 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
• Concurrent serious medical condition that would impair study participation or impact the assessment of treatment related toxicity