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

Study 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.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studied[225Ac]Ac-AKY-1189 (therapeutic) and [64Cu]Cu-AKY-1189 (imaging)

The study team can explain what participation involves.

Who it may be forNon-small cell lung cancer (NSCLC) · Locally advanced · Metastatic or stage IV

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Sep 17, 2026 · Source: ClinicalTrials.gov

Is enrollment open?Recruiting

The study is currently accepting participants.

What kind of study?Phase 1

Interventional

Where is it offered?14 U.S. locations

Locations may change over time.

Who runs it?Aktis Oncology, Inc.

Study sponsor

Study overview

What this study is about

Purpose: Treatment
Study type: Interventional
Phase: Phase 1
Sponsor: Aktis Oncology, Inc.
Interventions being studied: Drug: [225Ac]Ac-AKY-1189 (therapeutic); Drug: [64Cu]Cu-AKY-1189 (imaging)

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How this study is categorized

These labels come from structured fields and exact terms in the public record.

Cancer type

Non-small cell lung cancer (NSCLC)→

Disease setting

Locally advanced→Metastatic or stage IV→

Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion criteria

Histologic or cytologic confirmation of locally advance or metastatic disease
Radiologic confirmation on CT of at least one measurable tumor lesion per RECIST v1.1
ECOG Performance Status of 0 or 1
Adequate end-organ function
Ability to give informed consent and comply with study requirements
Patients with CNS metastases are eligible if they have received therapy and are neurologically stable, asymptomatic and not receiving corticosteroids
Documented disease progression on prior line of therapy for metastatic disease

Reasons someone may not be able to joinExclusion criteria

Prior treatment with a therapeutic radiopharmaceutical
Prior treatment with a Nectin-4 targeted therapy, except enfortumab vedotin
Received an investigational agent within the previous 28days
Prior treatment with a cytotoxic chemotherapy, targeted therapy, biologic agent, immunotherapy or external-beam radiotherapy in the 3 weeks prior to study treatment
Concurrent serious medical condition that would impair study participation or impact the assessment of treatment related toxicity

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

Study sites

U.S. locations

City of HopeDuarte, California
Hoag Memorial Hospital PresbyterianIrvine, California
Biogenix Molecular, LLCMiami, Florida
Advent Health Medical Group Radiation Oncology at Central FloridaOrlando, Florida
Moffitt Cancer CenterTampa, Florida
University of IowaIowa City, Iowa
University of KansasWestwood, Kansas
United TheranosticsGlen Burnie, Maryland
BAMF HealthGrand Rapids, Michigan
Icahn School of Medicine at Mt. SinaiNew York, New York
Memorial Sloan Kettering Cancer CenterNew York, New York
UPMCPittsburgh, Pennsylvania

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Sep 17, 2026. Always confirm current availability with the study team.

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