RECRUITING Phase 1 ClinicalTrials.gov

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

Sponsor: Aktis Oncology, Inc. • ClinicalTrials.gov ID: NCT07020117

Registry updated: 2026-09-17

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Description

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.

Interventions

[225Ac]Ac-AKY-1189 (therapeutic) (Drug)
\[225Ac\]Ac-AKY-1189 Injection
[64Cu]Cu-AKY-1189 (imaging) (Drug)
\[64Cu\]Cu-AKY-1189 Injection

Eligibility criteria

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

Conditions

Urothelial Carcinoma Bladder Triple Negative Breast Cancer (TNBC) Hormone Receptor Positive Breast Adenocarcinoma Non Small Cell Lung Cancer Cervical Adenocarcinoma Colorectal Adenocarcinoma Head and Neck Cancer

Locations

City of Hope — Duarte, California, United States
Hoag Memorial Hospital Presbyterian — Irvine, California, United States
Biogenix Molecular, LLC — Miami, Florida, United States
Advent Health Medical Group Radiation Oncology at Central Florida — Orlando, Florida, United States
Moffitt Cancer Center — Tampa, Florida, United States
University of Iowa — Iowa City, Iowa, United States
University of Kansas — Westwood, Kansas, 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
Memorial Sloan Kettering Cancer Center — New York, New York, United States
UPMC — Pittsburgh, Pennsylvania, United States
MD Anderson Cancer Center — Houston, Texas, United States
Huntsman Cancer Institute — Salt Lake City, Utah, United States

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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