RECRUITING

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

Conditions

Metastatic Castration-Resistant Prostate Cancer (mCRPC)Progressive PSMA-Positive Metastatic Castration-Resistant Prostate Cancer Prostate-specific membrane antigen PSMA Metastatic Castration-Resistant Prostate Cancer mCRPC Renal impairment Moderately impaired renal function Severely impaired renal function Normal renal function lutetium (177Lu) vipivotide tetraxetan AAA617 Dosimetry QTc prolongation post marketing requirement

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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.

Quick Facts

Study Start:2024-04-04

Study Completion:2026-10-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06004661

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 100 Years

Sexes Eligible for Study:MALE

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. An Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 2. 68Ga-PSMA-11 Positron emission tomography (PET)/CT scan positive, and eligible as determined by the sponsor's central reader. 3. A castrate level of serum/plasma testosterone (\< 50 ng/dL or \< 1.7 nmol/L). 4. Documented progressive mCRPC will be based on at least 1 of the following criteria: * 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 renal disease without evidence of renal progressive disease (stable renal disease is defined as no significant change, such as a stable eGFR, 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 * Moderate renal impairment: participants with eGFR \>= 30 to =\< 59 mL/min * Severe renal impairment: participants with eGFR \>= 15 to =\< 29 mL/min	1. Previous treatment with PSMA-targeted radioligand therapy. 2. Previous treatment with any of the following within 6 months of enrollment confirmation: Strontium-89, Samarium-153, Rhenium-186, Rhenium-188, Radium-223 or hemi-body irradiation. 3. Use of agents known to prolong the QT interval from start of screening to end of Cycle 1, unless they can be permanently discontinued for the duration of study. 4. Current severe urinary incontinence, hydronephrosis, severe voiding dysfunction, any level of urinary obstruction requiring indwelling/condom catheters. Participants with postrenal impairment, like obstructions, retroperitoneal fibrosis (eg after prostectomy) must be excluded or first resolved to ≤ Grade 1. 5. History or current diagnosis of ECG abnormalities indicating significant risk of safety for participants participating in the study such as: * 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 (physical exam or 12 lead ECG) \<60 bpm

Inclusion Criteria

Exclusion Criteria

1. An Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
2. 68Ga-PSMA-11 Positron emission tomography (PET)/CT scan positive, and eligible as determined by the sponsor's central reader.
3. A castrate level of serum/plasma testosterone (\< 50 ng/dL or \< 1.7 nmol/L).
4. Documented progressive mCRPC will be based on at least 1 of the following criteria:
* 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 renal disease without evidence of renal progressive disease (stable renal disease is defined as no significant change, such as a stable eGFR, 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
* Moderate renal impairment: participants with eGFR \>= 30 to =\< 59 mL/min
* Severe renal impairment: participants with eGFR \>= 15 to =\< 29 mL/min

1. Previous treatment with PSMA-targeted radioligand therapy.
2. Previous treatment with any of the following within 6 months of enrollment confirmation: Strontium-89, Samarium-153, Rhenium-186, Rhenium-188, Radium-223 or hemi-body irradiation.
3. Use of agents known to prolong the QT interval from start of screening to end of Cycle 1, unless they can be permanently discontinued for the duration of study.
4. Current severe urinary incontinence, hydronephrosis, severe voiding dysfunction, any level of urinary obstruction requiring indwelling/condom catheters. Participants with postrenal impairment, like obstructions, retroperitoneal fibrosis (eg after prostectomy) must be excluded or first resolved to ≤ Grade 1.
5. History or current diagnosis of ECG abnormalities indicating significant risk of safety for participants participating in the study such as:
* 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 (physical exam or 12 lead ECG) \<60 bpm

Contacts and Locations

Study Contact

Novartis Pharmaceuticals

CONTACT

1-888-669-6682

novartis.email@novartis.com

Novartis Pharmaceuticals

CONTACT

+41613241111

novartis.email@novartis.com

Principal Investigator

Novartis Pharmaceuticals

STUDY_DIRECTOR

Novartis Pharmaceuticals

Study Locations (Sites)

Mount Sinai Hosp School of Med

New York, New York, 10029

United States

Collaborators and Investigators

Sponsor: Novartis Pharmaceuticals

Novartis Pharmaceuticals, STUDY_DIRECTOR, Novartis Pharmaceuticals

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-04-04

Study Completion Date2026-10-01

Study Record Updates

Study Start Date2024-04-04

Study Completion Date2026-10-01

Terms related to this study

Keywords Provided by Researchers

Progressive PSMA-Positive Metastatic Castration-Resistant Prostate Cancer
Prostate-specific membrane antigen
PSMA
Metastatic Castration-Resistant Prostate Cancer
mCRPC
Renal impairment
Moderately impaired renal function
Severely impaired renal function
Normal renal function
lutetium (177Lu) vipivotide tetraxetan
AAA617
Dosimetry
QTc prolongation
post marketing requirement

Additional Relevant MeSH Terms

Metastatic Castration-Resistant Prostate Cancer (mCRPC)