PRadR 2 - A single center, open-label, Phase I study evaluating 161Tb-PSMA therapy in adult patients with metastatic clear cell renal cell carcinoma

Metastatic clear cell renal cell carcinoma

Dose-limiting toxicities (DLT) defined as the following adverse events (AEs) graded according to NCI CTCAE V6.0, assessed as related to 161Tb-PSMA-1, occurring during the first cycle of treatment (i.e., 6 weeks)

Objective Response Rate (ORR) defined as the rate of patients with a complete or partial response (CR or PR) according to RECIST v1.1., Objective Response Rate at 24 weeks (ORR-24W) defined as the rate of patients with a complete or partial response (CR or PR) according to RECIST v1.1, 24 weeks after first dose., Disease Control Rate after 24 weeks of treatment (DCR24w) defined as the rate of patients with a stable disease, a complete or a partial response at 24 weeks after treatment start according to RECIST v1.1., Best Overall Response Rate (BORR), Duration of response (DOR) defined as the time from the date of first documented response until date of documented progression per RECIST 1.1 or death due to any cause., Progression Free Survival (PFS) defined as the time from treatment start until the date of documented progression or death due to any cause., Overall Survival (OS) defined as the time from treatment start to the date of death., Nature, incidence, severity and relatedness to study treatment of AEs and AESIs graded using Common Terminology Criteria for Adverse Events (CTCAE) V6.0

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