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A Study of [225Ac]Ac-AKY-1189 in Patients With Solid Tumors
Sponsor: Aktis Oncology, Inc.
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.
Official title: NECTINIUM-2: A Phase 1b, 2 Part, Multicenter, Single Arm, Open Label Study to Evaluate the Safety and Efficacy of a Nectin-4 Radiopharmaceutical ([225Ac]Ac-AKY-1189) in Patients With Previously Treated Locally Advanced or Metastatic Solid Tumors
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
150
Start Date
2025-08-22
Completion Date
2032-06
Last Updated
2026-03-04
Healthy Volunteers
No
Conditions
Interventions
[225Ac]Ac-AKY-1189 (therapeutic)
\[225Ac\]Ac-AKY-1189 Injection
[64Cu]Cu-AKY-1189 (imaging)
\[64Cu\]Cu-AKY-1189 Injection
Locations (9)
City of Hope
Duarte, California, United States
Hoag Memorial Hospital Presbyterian
Irvine, California, United States
Biogenix Molecular, LLC
Miami, Florida, United States
University of Iowa
Iowa City, Iowa, United States
United Theranostics
Glen Burnie, Maryland, United States
BAMF Health
Grand Rapids, Michigan, United States
Icahn School of Medicine at Mt. Sinai
New York, New York, United States
UPMC
Pittsburgh, Pennsylvania, United States
MD Anderson Cancer Center
Houston, Texas, United States