A Study of [225Ac]Ac-AKY-1189 in Patients With Solid Tumors
Recruiting · NCT07020117 · Interventional (participants receive a specific treatment) · Lead sponsor: Aktis Oncology, Inc.
View the official record on ClinicalTrials.gov →Interventions studied
[225Ac]Ac-AKY-1189 (therapeutic)[64Cu]Cu-AKY-1189 (imaging)
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 1
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
13 locations listed across 10 US states.
- 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
- 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