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
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)
How this study is categorized
These labels come from structured fields and exact terms in the public record.
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.
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.