Actively Recruiting
An Open-label Study of Lutetium (177Lu) Vipivotide Tetraxetan in Men With Progressive PSMA-Positive Metastatic Castration-Resistant Prostate Cancer and Varying Kidney Function
Led by Novartis Pharmaceuticals · Updated on 2026-03-06
20
Participants Needed
9
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating how moderate and severe kidney problems affect the distribution, radiation dose, and safety of lutetium (177Lu) vipivotide tetraxetan (AAA617) in men with progressive PSMA-positive metastatic castration-resistant prostate cancer (mCRPC). This phase II, open-label study also examines the risk of QT interval prolongation, a heart rhythm concern, in this group. The study includes participants with normal, moderate, and severe kidney function. Participants will receive AAA617 intravenously at a dose of 7.4 GBq every 6 weeks. Those with normal or moderate kidney function will get up to 6 treatment cycles, while those with severe impairment will receive 3 cycles, with a possible extension to 6 cycles based on safety and benefit. Before treatment, all will have a 68Ga-PSMA-11 PET/CT scan to confirm PSMA positivity. After treatment, participants may join a long-term follow-up study to monitor safety for up to 10 years, or stay in this study's follow-up period for up to one year if needed. During the study, researchers will assess radiation absorbed by kidneys and other organs, blood concentrations of AAA617 over time, and related pharmacokinetic parameters. They will also monitor kidney function changes, dose adjustments, and the relationship between drug levels and QT interval changes. Safety, tumor response, and disease control will be tracked up to about 36 weeks, with longer monitoring of PSA response. The study plans to enroll about 20 participants across three kidney function groups, with regular evaluations during and after treatment.
CONDITIONS
Brief 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 confirming PSMA-positive tumors
- Castrate levels of serum/plasma testosterone (< 50 ng/dL or < 1.7 nmol/L)
- Documented progressive metastatic castration-resistant prostate cancer with at least one of PSA progression, soft-tissue progression, or bone disease progression
- Stable chronic kidney disease without significant recent deterioration
- Kidney function classified by eGFR as normal (≥ 90), moderate (30 to ≤ 59), or severe (15 to ≤ 29) mL/min/1.73m2
You will not qualify if you...
- Previous treatment with PSMA-targeted radioligand therapy
- Treatment with bone-seeking radiopharmaceuticals or hemi-body irradiation within 6 months prior to enrollment
- Use of drugs that prolong the QT interval during screening and Cycle 1 unless permanently stopped
- Severe urinary conditions such as incontinence, hydronephrosis, voiding dysfunction, or urinary obstruction requiring catheter use
- Significant cardiac arrhythmias or ECG abnormalities indicating safety risk, including sustained ventricular tachycardia, advanced AV block without pacemaker, familial long QT syndrome, or resting heart rate below 60 bpm
- Other protocol-defined criteria as applicable
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) including a 68Ga-PSMA-11 PET/CT scan to confirm PSMA positivity
Duration - Up to 36 weeks
Participants receive AAA617 intravenously once every 6 weeks for up to 6 cycles (Cohorts A and B) or up to 3 cycles with possible extension to 6 cycles (Cohort C) based on safety and benefit assessment.
Treatment visits every 6 weeks for up to 6 cycles plus pharmacokinetic blood sampling at multiple time points during Cycle 1
Duration - Up to 10 years
Participants are monitored for safety up to 1 year after the last treatment or up to 10 years if enrolled in a long-term follow-up study.
Periodic safety follow-up visits up to 1 year or longer if enrolled in a separate long-term follow-up study
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
N
Novartis Pharmaceuticals
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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