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New treatment option for Urothelial Carcinoma Bladder
Official title A Study of [225Ac]Ac-AKY-1189 in Patients With Solid Tumors
ClinicalTrials.gov ID: NCT07020117
What this study is testing
What is [225Ac]Ac-AKY-1189 (therapeutic)?
[225Ac]Ac-AKY-1189 (therapeutic) is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for urothelial carcinoma bladder.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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
You likely can't join 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...
- Concurrent serious medical condition that would impair study participation or impact the assessment of treatment related toxicity
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Duarte, California, United States
- Irvine, California, United States
- Miami, Florida, United States
- Orlando, Florida, United States
- Iowa City, Iowa, United States
- Westwood, Kansas, United States
- Glen Burnie, Maryland, United States
- Grand Rapids, Michigan, United States
- New York, New York, United States
- Pittsburgh, Pennsylvania, United States
- Houston, Texas, United States
- Salt Lake City, Utah, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Duarte, California, United States; Irvine, California, United States; Miami, Florida, United States; Orlando, Florida, United States; Iowa City, Iowa, United States; Westwood, Kansas, United States and 6 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.