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

Summary

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.

Shortened from the sponsor's brief summary. View official record on ClinicalTrials.gov

Conditions studied

• Urothelial Carcinoma Bladder
• Triple Negative Breast Cancer (TNBC)
• Hormone Receptor Positive Breast Adenocarcinoma
• Non Small Cell Lung Cancer
• Cervical Adenocarcinoma
• Colorectal Adenocarcinoma
• Head and Neck Cancer

Eligibility basics and study details

Study type

Interventional

Phase

Phase 1

Ages

18 years and older

Sex

All

Healthy volunteers

Not accepted

Sponsor

Aktis Oncology, Inc.

Last updated on ClinicalTrials.gov

September 17, 2026

These are the basic criteria only. The full inclusion and exclusion criteria are on the official record, and the study team decides who can take part.

US recruiting sites