OncoMatch/Clinical Trials/NCT07020117
A Study of [225Ac]Ac-AKY-1189 in Patients With Solid Tumors
Is NCT07020117 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies multiple treatments including [225Ac]Ac-AKY-1189 (therapeutic) and [64Cu]Cu-AKY-1189 (imaging) for urothelial carcinoma bladder.
Treatment: [225Ac]Ac-AKY-1189 (therapeutic) · [64Cu]Cu-AKY-1189 (imaging) — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Urothelial Carcinoma
Triple-Negative Breast Cancer
Breast Carcinoma
Small Cell Lung Cancer
Cervical Cancer
Colorectal Cancer
Head and Neck Squamous Cell Carcinoma
Disease stage
Metastatic disease required
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: any prior line of therapy for metastatic disease — metastatic
Documented disease progression on prior line of therapy for metastatic disease
Cannot have received: therapeutic radiopharmaceutical
Prior treatment with a therapeutic radiopharmaceutical
Cannot have received: Nectin-4 targeted therapy
Exception: except enfortumab vedotin
Prior treatment with a Nectin-4 targeted therapy, except enfortumab vedotin
Cannot have received: investigational agent
Received an investigational agent within the previous 28days
Cannot have received: cytotoxic chemotherapy
Prior treatment with a cytotoxic chemotherapy...in the 3 weeks prior to study treatment
Cannot have received: targeted therapy
Prior treatment with a...targeted therapy...in the 3 weeks prior to study treatment
Cannot have received: biologic agent
Prior treatment with a...biologic agent...in the 3 weeks prior to study treatment
Cannot have received: immunotherapy
Prior treatment with a...immunotherapy...in the 3 weeks prior to study treatment
Cannot have received: external-beam radiotherapy
Prior treatment with a...external-beam radiotherapy in the 3 weeks prior to study treatment
Lab requirements
Blood counts
Adequate end-organ function
Kidney function
Adequate end-organ function
Liver function
Adequate end-organ function
Adequate end-organ function
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- City of Hope · Duarte, California
- Hoag Memorial Hospital Presbyterian · Irvine, California
- Biogenix Molecular, LLC · Miami, Florida
- University of Iowa · Iowa City, Iowa
- United Theranostics · Glen Burnie, Maryland
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify