An Open-label Dosimetry, Tolerability and Safety Study of lutetium (177Lu) vipivotide tetraxetan in Patients with Progressive PSMA-Positive Metastatic Castration-Resistant Prostate Cancer (mCRPC) with Moderately and Severely Impaired and with Normal Renal Function

Prior treatment

• Previous treatment with PSMA-targeted radioligand therapy.
• 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.

Other illness

• 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 prostatectomy) must be excluded or first resolved to ≤ Grade 1

Lab values

• 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.
• 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 (12 lead ECG) <60 bpm

• An Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
• 68Ga-PSMA-11 Positron emission tomography (PET)/CT scan positive, and eligible as determined by the sponsor’s central reader
• A castrate level of serum/plasma testosterone (< 50 ng/dL or < 1.7 nmol/L).
• 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, Scher et al 2016).
• 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 as documented by ≤ 20% difference between two separate eGFR measurements calculated with the MDRD equation. In addition, all eGFR values available within 3 months prior to study entry should be classified in the same eGFR category as the calculated eGFR at screening).
• Kidney function based on eGFR by Modification of Diet in Renal Disease (MDRD) equation (at first screening assessment): • 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