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

Launched by NOVARTIS PHARMACEUTICALS · Aug 16, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a treatment called lutetium (177Lu) vipivotide tetraxetan for men with a type of prostate cancer known as metastatic castration-resistant prostate cancer (mCRPC). The trial aims to see how this treatment affects patients who have different levels of kidney function, specifically those with moderate and severe kidney impairment, as well as those with normal kidney function. Researchers will look at how the treatment spreads in the body, its safety, and any potential heart rhythm issues it may cause.

To participate in this study, men aged 65 to 74 who have a specific type of imaging scan showing their cancer should have a certain level of health and kidney function. Key eligibility criteria include having a certain performance status (meaning they can carry out daily activities with some limitations), a specific level of testosterone, and stable kidney health. Participants will receive the treatment and be monitored throughout the study for any side effects or changes in their condition. It's important for potential participants to understand that there are also specific criteria that might exclude them from joining, such as prior treatments or significant heart problems.

Gender

MALE

Eligibility criteria

• Key Inclusion 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
• Key Exclusion Criteria:
• • 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
• • Other protocol-defined inclusion/exclusion criteria may apply.