RecruitingPhase 1NCT07020117

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

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.

Checked against the public recordLast updated Jul 10, 2026 · Source: ClinicalTrials.gov

StatusRecruiting
PhasePhase 1
U.S. locations12
SponsorAktis Oncology, Inc.
01
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)
02
Explore related studies

How this study is categorized

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

03
Public criteria

Who may be able to participate

Inclusion 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 Exclusion 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.

04
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
  • 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
  • UPMCPittsburgh, Pennsylvania
  • MD Anderson Cancer CenterHouston, Texas
  • Huntsman Cancer InstituteSalt Lake City, Utah

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jul 10, 2026. Always confirm current availability with the study team.

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