XCancer

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

Description:

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

Government Study Link:

NCT07020117 - Click here to see study on

ClinicalTrials.gov

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
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