RecruitingPhase 1NCT07020117

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

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

Sponsor

Aktis Oncology, Inc.

Enrollment

150 participants

Start Date

Aug 22, 2025

Study Type

INTERVENTIONAL

Conditions

Urothelial Carcinoma Bladder

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new targeted radioactive treatment called [225Ac]Ac-AKY-1189 in patients with advanced solid tumors, to find the safest dose and see if it can slow or shrink cancer. **You may be eligible if...** - You have locally advanced or metastatic solid cancer confirmed by biopsy - Your cancer has at least one measurable tumor visible on CT scan - You are generally functional (ECOG 0–1) - Your cancer has progressed on at least one prior treatment - You have brain metastases that are stable and not requiring steroids **You may NOT be eligible if...** - You have previously received a therapeutic radiopharmaceutical - You have previously received a Nectin-4 targeted therapy (other than enfortumab vedotin) - You have received an investigational drug within the past 28 days - You have significant heart, liver, or kidney problems Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

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NCT07020117

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