Actively Recruiting
Study of Lutetium (177Lu) Vipivotide Tetraxetan in mCRPC Participants With Moderately and Severely Impaired and With Normal Renal Function
Led by Novartis Pharmaceuticals · Updated on 2026-03-06
20
Participants Needed
9
Research Sites
114 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study will address health authorities' requests to determine whether moderate and severe renal impairment have an impact on the biodistribution, dosimetry and safety of lutetium (177Lu) vipivotide tetraxetan (AAA617) administered to participants with progressive PSMA-positive metastatic castration-resistant prostate cancer. The study will also characterize the risk of QT prolongation of AAA617 in this participant population.
CONDITIONS
Official Title
Study of Lutetium (177Lu) Vipivotide Tetraxetan in mCRPC Participants With Moderately and Severely Impaired and With Normal Renal Function
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male participants aged 18 to 100 years
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
- Positive 68Ga-PSMA-11 PET/CT scan confirmed by sponsor's central reader
- Castrate level of serum/plasma testosterone (< 50 ng/dL or < 1.7 nmol/L)
- Documented progressive metastatic castration-resistant prostate cancer based on PSA progression, soft-tissue progression, or bone disease progression
- Stable chronic kidney disease without significant change in kidney function within 4 weeks before study entry
- Kidney function categorized by eGFR: normal (≥ 90 mL/min/1.73m2), moderate impairment (30 to ≤ 59 mL/min/1.73m2), or severe impairment (15 to ≤ 29 mL/min/1.73m2)
You will not qualify if you...
- Previous treatment with PSMA-targeted radioligand therapy
- Treatment with Strontium-89, Samarium-153, Rhenium-186, Rhenium-188, Radium-223, or hemi-body irradiation within 6 months before enrollment
- Use of drugs that prolong QT interval during screening to end of Cycle 1 unless they can be stopped permanently
- Severe urinary problems such as incontinence, hydronephrosis, severe voiding dysfunction, or urinary obstruction requiring catheters unless resolved to Grade 1 or less
- History or current heart rhythm abnormalities presenting significant safety risks, including clinically significant arrhythmias, second- or third-degree AV block without pacemaker, familial long QT syndrome, or resting heart rate below 60 bpm
- Other protocol-defined inclusion/exclusion criteria may apply
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 9 locations
1
Mount Sinai Hosp Med School
New York, New York, United States, 10029
Actively Recruiting
2
Novartis Investigative Site
Paris, France, 75014
Actively Recruiting
3
Novartis Investigative Site
Vandœuvre-lès-Nancy, France, 54511
Actively Recruiting
4
Novartis Investigative Site
Essen, Germany, 45147
Actively Recruiting
5
Novartis Investigative Site
München, Germany, 80377
Actively Recruiting
6
Novartis Investigative Site
Milan, Italy, 20141
Actively Recruiting
7
Novartis Investigative Site
Naples, Italy, 80131
Actively Recruiting
8
Novartis Investigative Site
Granada, Andalusia, Spain, 18014
Actively Recruiting
9
Novartis Investigative Site
El Palmar, Murcia, Spain, 30120
Active, Not Recruiting
Research Team
N
Novartis Pharmaceuticals
CONTACT
N
Novartis Pharmaceuticals
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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