Clinical Trial · NCT07020117

A Study of [225Ac]Ac-AKY-1189 in Patients With Solid Tumors

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 Phase 2 dose.

Sponsor

Unknown Organization

Phase

Phase 1

Contacts

Janet Horton, MD (CONTACT)

aky-1189-01inquiries@aktisoncology.com

978-208-3986

ClinicalTrials.gov

NCT07020117

Drug / Compound

AKY-1189

Isotope(s):

Target(s):

Nectin-4

Ligand Class: Small Proteins and Antibody Fragments

AKY-1189

Isotope(s):

Target(s):

Nectin-4

Ligand Class: Small Proteins and Antibody Fragments

Eligibility

Inclusion

Radiologic confirmation on CT of at least one measurable tumor lesion per RECIST v1.1
Histologic or cytologic confirmation of locally advance or metastatic disease
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

Prior treatment with a cytotoxic chemotherapy, targeted therapy, biologic agent, immunotherapy or external-beam radiotherapy in the 3 weeks prior to study treatment
Prior treatment with a therapeutic radiopharmaceutical
Prior treatment with a Nectin-4 targeted therapy, except enfortumab vedotin