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A Study of [225Ac]Ac-AKY-2519 in Patients With B7-H3 Expressing Solid Tumors
Sponsor: Aktis Oncology, Inc.
Summary
This is a Phase 1b, 2-part, multi-center, open-label study to evaluate the safety, tolerability, dosimetry, and pharmacokinetics (PK) of \[64Cu\]Cu-AKY-2519 and/or \[225Ac\]Ac-AKY-2519, as well as the preliminary anti-tumor activity of \[225Ac\]Ac-AKY-2519 in participants with B7-H3 imaging positive solid tumors.
Official title: BActinium-2: A Phase 1b, 2 Part, Multicenter, Open Label Study to Evaluate the Safety and Efficacy of Intravenous Administration of a B7-H3 Radiopharmaceutical ([225Ac]Ac AKY 2519) in Participants With B7-H3 Imaging Positive Solid Tumors
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
152
Start Date
2026-11
Completion Date
2033-12
Last Updated
2026-11-02
Healthy Volunteers
No
Conditions
Interventions
[225Ac]Ac-AKY-2519 (therapeutic)
\[225Ac\]Ac-AKY-2519 Injection
[64Cu]Cu-AKY-2519 (imaging)
\[64Cu\]Cu-AKY-2519 Injection
Locations (2)
Biogenix Molecular, LLC
Miami, Florida, United States
MD Anderson Cancer Center
Houston, Texas, United States