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Study of Lutetium (177Lu) Vipivotide Tetraxetan for mCRPC with Kidney Impairment

This study is looking at Lutetium (177Lu) Vipivotide Tetraxetan (also called AAA617) for men with metastatic castration-resistant prostate cancer (mCRPC). This is prostate cancer that has spread and is no longer responding to treatments that lower testosterone. Researchers want to understand how AAA617 is distributed in the body, its safety, and how it affects people with normal, moderate, or severe kidney function. You would receive AAA617 intravenously (into a vein) every six weeks. Before starting, you will have a special scan (68Ga-PSMA-11 PET/CT) to confirm your cancer is PSMA-positive. The study will measure how much radiation is absorbed by your kidneys and other organs, and how much AAA617 is in your blood over time. The study is currently unclear about its recruitment status.

Study design
This is an open-label, non-randomized study with 23 participants. It is a single-arm study, meaning all participants receive the same treatment.
What's involved
You would receive intravenous doses of AAA617 every six weeks for 3 to 6 cycles. You would also have blood draws at specific times during the first cycle.
Compensation
Not stated in the trial record.
Follow-up
After treatment, you will be asked to join a long-term follow-up study to monitor your safety for up to 10 years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06004661

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

Active, Not Recruiting
PHASE2Ages 18+InterventionalTreatment
Novartis Pharmaceuticals
~23 participants
Updated 2026-07-10 on ClinicalTrials.gov
What's tested:AAA61768Ga-PSMA-11

At a glance

Recruiting sites
0 of 9 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Absorbed radiation dose in kidneys and selected organs
Measured over Up to 36 weeks
+11 more outcomes measured

Conditions

Metastatic Castration-Resistant Prostate Cancer (mCRPC)

Explore related trials

Prostate Carcinoma

Where it's being run

9 sites across 6 states
France2
Germany2
Italy2
New York1
Andalusia1
Murcia1

Study leadership

  • Novartis Pharmaceuticals · STUDY_DIRECTOR · Novartis Pharmaceuticals

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Serum/plasma Prostate-Specific Antigen (PSA) progression defined as 2 consecutive increases in PSA over a previous reference value measured at least 1 week prior. The minimal start value is 2.0 ng/mL
Soft-tissue progression defined as an increase \>= 20% in the sum of the diameter (SOD) (short axis for nodal lesions and long axis for non-nodal lesions) of all target lesions based on the smallest SOD since treatment started or the appearance of one or more new lesions.
Progression of bone disease: evaluable disease or new bone lesions(s) by bone scan (2+2 PCWG3 criteria) 5. Documented stable chronic renal disease without evidence of further deterioration in renal function (stable chronic renal disease is defined as no significant change in renal function within 4 weeks prior to study entry. 6. Kidney function based on eGFR by Modification of Diet in Renal Disease (MDRD) equation:
Normal renal function: participants with eGFR \>= 90 mL/min/1.73m2
Moderate renal impairment: participants with eGFR \>= 30 to =\< 59 mL/min/1.73m2
Severe renal impairment: participants with eGFR \>= 15 to =\< 29 mL/min/1.73m2

Exclusion

Concomitant clinically significant cardiac arrhythmias, e.g. sustained ventricular tachycardia, and clinically significant second- or third-degree AV block without a pacemaker.
History of familial long QT syndrome or known family history of Torsades de Pointe.
Resting heart rate (12 lead ECG) \<60 bpm

What this trial measures

  • Absorbed radiation dose in kidneys and selected organsUp to 36 weeks

    The absorbed dose in kidneys and selected organs will be summarized with descriptive statistics.

  • Concentrations of AAA617 in blood over timeCycle (C) 1 Day (D) 1 (pre dose, end of infusion, 20 minutes (min), 60 min, 2 and 4 hours (h) post infusion), C1 D2 (24 h post infusion), C1 D3 (48 h post infusion), C1 D4 (72 h post infusion), C1 D6 (120-144 h post infusion). Cycle=6 weeks

    Venous whole blood samples will be collected for activity-based pharmacokinetics characterization. Blood concentration of \[177Lu\]Lu-PSMA-617 will be summarized with descriptive statistics.

  • Area under the serum concentration-time curve from time zero to the time of last quantifiable concentration (AUClast) of 177Lu-PSMA-617Cycle (C) 1 Day (D) 1 (pre dose, end of infusion, 20 minutes (min), 60 min, 2 and 4 hours (h) post infusion), C1 D2 (24 h post infusion), C1 D3 (48 h post infusion), C1 D4 (72 h post infusion), C1 D6 (120-144 h post infusion). Cycle=6 weeks

    Venous whole blood samples will be collected for activity-based pharmacokinetics characterization. AUClast will be listed and summarized using descriptive statistics.

  • Time of maximum observed drug concentration occurrence (Tmax) of 177Lu-PSMA-617Cycle (C) 1 Day (D) 1 (2 and 4 hours (h) post infusion), C1 D2 (24 h post infusion), C1 D3 (48 h post infusion), C1 D4 (72 h post infusion), C1 D6 (120-144 h post infusion). Cycle = 6 weeks

    Venous whole blood samples will be collected for activity-based pharmacokinetics characterization. Tmax will be listed and summarized using descriptive statistics.

  • Observed maximum plasma concentration (Cmax) of 177Lu-PSMA-617Cycle (C) 1 Day (D) 1 (pre dose, end of infusion, 20 minutes (min), 60 min, 2 and 4 hours (h) post infusion), C1 D2 (24 h post infusion), C1 D3 (48 h post infusion), C1 D4 (72 h post infusion), C1 D6 (120-144 h post infusion). Cycle=6 weeks

    Venous whole blood samples will be collected for activity-based pharmacokinetics characterization. Cmax will be listed and summarized using descriptive statistics.

  • Terminal elimination half-life (T^1/2) of 177Lu-PSMA-617Cycle (C) 1 Day (D) 1 (pre dose, end of infusion, 20 minutes (min), 60 min, 2 and 4 hours (h) post infusion), C1 D2 (24 h post infusion), C1 D3 (48 h post infusion), C1 D4 (72 h post infusion), C1 D6 (120-144 h post infusion). Cycle=6 weeks

    Venous whole blood samples will be collected for activity-based pharmacokinetics characterization. The half-live will be listed and summarized using descriptive statistics

  • Area under the concentration-time curve from time zero (pre-dose) extrapolated to infinite time (AUCinf) of 177Lu-PSMA-617Cycle (C) 1 Day (D) 1 (pre dose, end of infusion, 20 minutes (min), 60 min, 2 and 4 hours (h) post infusion), C1 D2 (24 h post infusion), C1 D3 (48 h post infusion), C1 D4 (72 h post infusion), C1 D6 (120-144 h post infusion). Cycle=6 weeks

    Venous whole blood samples will be collected for activity-based pharmacokinetics characterization. AUC(0-inf) will be listed and summarized using descriptive statistics.

  • Total systemic clearance for intravenous administration (CL) of 177Lu-PSMA-617Cycle (C) 1 Day (D) 1 (pre dose, end of infusion, 20 minutes (min), 60 min, 2 and 4 hours (h) post infusion), C1 D2 (24 h post infusion), C1 D3 (48 h post infusion), C1 D4 (72 h post infusion), C1 D6 (120-144 h post infusion). Cycle=6 weeks

    Venous whole blood samples will be collected for activity-based pharmacokinetics characterization. CL will be listed and summarized using descriptive statistics.

  • Volume of distribution during the terminal phase following intravenous elimination (Vz) of 177Lu-PSMA-617Cycle (C) 1 Day (D) 1 (pre dose, end of infusion, 20 minutes (min), 60 min, 2 and 4 hours (h) post infusion), C1 D2 (24 h post infusion), C1 D3 (48 h post infusion), C1 D4 (72 h post infusion), C1 D6 (120-144 h post infusion). Cycle=6 weeks

    Venous whole blood samples will be collected for activity-based pharmacokinetics characterization. Vz will be listed and summarized using descriptive statistics.

  • Change from baseline in eGFRat screening and at every visit, assessed up to 1 year after last treatment

    Change from baseline of eGFR will be summarized for each post-dose (post-baseline) timepoint. The summary includes table with descriptive statistics at baseline, post-baseline time points and change from baseline to post-baseline timepoints.

  • Dose modifications for AAA617Up to 36 weeks

    Dose modifications (dose interruptions and reductions) for AAA617 will be assessed and summarized using descriptive statistics.

  • Dose intensity for AAA617Up to 36 weeks

    Dose intensity for AAA617 will be assessed and summarized using descriptive statistics.