Clinical Trial

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

Recruiting Phase 1
View on ClinicalTrials.gov →
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.
Protocol Amendment History 1 change
notable Trial sites expanded: 9 -> 12 locations 2026-07-11
Trial Details
NCT Number NCT07020117
Lead Sponsor Aktis Oncology, Inc.
Conditions 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
Enrollment 150 participants
Start Date 2025-08-22
Primary Completion 2027-12 (estimated)
Study Completion 2032-06 (estimated)
Updated on ClinicalTrials.gov 2026-07-10