Actively Recruiting
A Study of [225Ac]Ac-AKY-1189 in Patients With Solid Tumors
Led by Aktis Oncology, Inc. · Updated on 2026-04-21
150
Participants Needed
9
Research Sites
353 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study of [225Ac]Ac-AKY-1189 in Patients With Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologic or cytologic confirmation of locally advanced 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
You will not qualify if you...
- Prior treatment with a therapeutic radiopharmaceutical
- Prior treatment with a Nectin-4 targeted therapy, except enfortumab vedotin
- Received an investigational agent within the previous 28 days
- Prior treatment with 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
AI-Screening
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Trial Site Locations
Total: 9 locations
1
City of Hope
Duarte, California, United States, 91010
Actively Recruiting
2
Hoag Memorial Hospital Presbyterian
Irvine, California, United States, 92618
Actively Recruiting
3
Biogenix Molecular, LLC
Miami, Florida, United States, 33165
Actively Recruiting
4
University of Iowa
Iowa City, Iowa, United States, 52242
Actively Recruiting
5
United Theranostics
Glen Burnie, Maryland, United States, 21061
Actively Recruiting
6
BAMF Health
Grand Rapids, Michigan, United States, 49503
Actively Recruiting
7
Icahn School of Medicine at Mt. Sinai
New York, New York, United States, 10029
Actively Recruiting
8
UPMC
Pittsburgh, Pennsylvania, United States, 15232
Actively Recruiting
9
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
J
Janet Horton, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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