A Study of [225Ac]Ac-AKY-1189 in Patients With Solid Tumors
NCT ID: NCT07020117
Last Updated: 2025-11-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
150 participants
INTERVENTIONAL
2025-08-22
2032-06-30
Brief Summary
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Detailed Description
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Part 1 is the dose escalation portion of the study, which will investigate ascending doses of \[225Ac\]Ac-AKY-1189 (up to 6 cycles) in patients with locally advanced or metastatic solid tumors. The aim of Part 1 is to determine the maximum tolerated dose (MTD) or maximum administered dose (MAD) and the recommended Phase 2 dose.
Part 2 will be the dose expansion portion of the study and will enroll locally advanced or metastatic solid tumor patients who are identified as Nectin-4 positive by \[64Cu\] Cu-AKY-1189. Part 2 aims to further assess the efficacy of \[225Ac\]Ac-AKY-1189 at the RP2D in 3 different cohorts of patients.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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[225Ac]Ac-AKY-1189
[225Ac]Ac-AKY-1189 (therapeutic)
\[225Ac\]Ac-AKY-1189 Injection
[64Cu]Cu-AKY-1189 (imaging)
\[64Cu\]Cu-AKY-1189 Injection
Interventions
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[225Ac]Ac-AKY-1189 (therapeutic)
\[225Ac\]Ac-AKY-1189 Injection
[64Cu]Cu-AKY-1189 (imaging)
\[64Cu\]Cu-AKY-1189 Injection
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
ALL
No
Sponsors
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Aktis Oncology, Inc.
INDUSTRY
Responsible Party
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Locations
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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
BAMF Health
Grand Rapids, Michigan, United States
Icahn School of Medicine at Mt. Sinai
New York, New York, United States
MD Anderson Cancer Center
Houston, Texas, United States
Countries
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Central Contacts
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Facility Contacts
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Kristin Plichta, MD, PhD
Role: backup
Role: primary
Other Identifiers
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AKY-1189-01
Identifier Type: -
Identifier Source: org_study_id
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