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RECRUITING
NCT07887971
PHASE1

A Study of [225Ac]Ac-AKY-2519 in Patients With B7-H3 Expressing Solid Tumors

Sponsor: Aktis Oncology, Inc.

View on ClinicalTrials.gov

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

Interventions

DRUG

[225Ac]Ac-AKY-2519 (therapeutic)

\[225Ac\]Ac-AKY-2519 Injection

DRUG

[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