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RECRUITING
NCT07020117
PHASE1

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

Sponsor: Aktis Oncology, Inc.

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.

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

Interventions

DRUG

[225Ac]Ac-AKY-1189 (therapeutic)

\[225Ac\]Ac-AKY-1189 Injection

DRUG

[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