RecruitingPhase 2NCT06004661

Study of Lutetium (177Lu) Vipivotide Tetraxetan in mCRPC Participants With Moderately and Severely Impaired and With Normal Renal Function

An Open-label Dosimetry, Biodistribution, Tolerability and Safety Study of Lutetium (177Lu) Vipivotide Tetraxetan in Participants With Progressive PSMA-Positive Metastatic Castration-Resistant Prostate Cancer (mCRPC) With Moderately and Severely Impaired and With Normal Renal Function.


Sponsor

Novartis Pharmaceuticals

Enrollment

20 participants

Start Date

Apr 4, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Sex: MALEMin Age: 18 YearsMax Age: 100 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a radioactive treatment called lutetium-177 PSMA (Lu-PSMA) in men with advanced prostate cancer that no longer responds to hormone therapy — including men with varying levels of kidney function. **You may be eligible if:** - You have prostate cancer that has spread and is no longer responding to hormone therapy (called mCRPC) - Your PSMA scan is positive - Your testosterone level is very low (castrate level) - Your cancer is progressing based on rising PSA, new bone lesions, or tumor growth **You may NOT be eligible if:** - You have previously received PSMA-targeted radioactive therapy - You have recently received certain bone-targeting radioactive treatments (e.g., Radium-223) - You have severe urinary obstruction or incontinence - You have significant heart rhythm problems - You are taking medications that prolong the heart's QT interval Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAAA617

Administered intravenously once every cycles (1 cycle = 6 weeks)

DRUG68Ga-PSMA-11

Single intravenous dose of approximately 150 MBq


Locations(9)

Mount Sinai Hosp Med School

New York, New York, United States

Novartis Investigative Site

Paris, France

Novartis Investigative Site

Vandœuvre-lès-Nancy, France

Novartis Investigative Site

Essen, Germany

Novartis Investigative Site

München, Germany

Novartis Investigative Site

Milan, Italy

Novartis Investigative Site

Naples, Italy

Novartis Investigative Site

Granada, Andalusia, Spain

Novartis Investigative Site

El Palmar, Murcia, Spain

View Full Details on ClinicalTrials.gov

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NCT06004661


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