A Study of [225Ac]Ac-AKY-1189 in Patients With Solid Tumors
Recruiting now · Phase 1
Conditions studied: 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
In brief
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.
Key facts
- Study ID
- NCT07020117
- Run by
- Aktis Oncology, Inc.
- People needed
- 150
- Starts
- 2025-08-22
- Expected to finish
- 2032-06-01
- Last updated by the study team
- 2026-07-10
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- City of Hope — Duarte, California, United States (enrolling)
- Hoag Memorial Hospital Presbyterian — Irvine, California, United States (enrolling)
- Biogenix Molecular, LLC — Miami, Florida, United States (enrolling)
- Advent Health Medical Group Radiation Oncology at Central Florida — Orlando, Florida, United States (enrolling)
- University of Iowa — Iowa City, Iowa, United States (enrolling)
- University of Kansas — Westwood, Kansas, United States (enrolling)
- United Theranostics — Glen Burnie, Maryland, United States (enrolling)
- BAMF Health — Grand Rapids, Michigan, United States (enrolling)
- Icahn School of Medicine at Mt. Sinai — New York, New York, United States (enrolling)
- UPMC — Pittsburgh, Pennsylvania, United States (enrolling)
- MD Anderson Cancer Center — Houston, Texas, United States (enrolling)
- Huntsman Cancer Institute — Salt Lake City, Utah, United States (enrolling)
Full record on ClinicalTrials.gov
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