Study to Evaluate the Efficacy and Safety of 177Lu-NYM032 Injection in Participants With Progressive, PSMA-Positive Metastatic Castration-Resistant Prostate Cancer (mCRPC)

Patients with PSMA positive scans will be randomized in a 2:1 ratio to receive either 177Lu-NYM032 plus best supportive/best standard of care or to receive best supportive/best standard of care only. Best supportive/best standard of care will be determined by the treating physician/investigator but will exclude investigational agents, cytotoxic chemotherapy, other systemic radioisotopes, and hemi-body radiotherapy. Novel androgen receptor pathway inhibitor (ARPI) (such as abiraterone or enzalutamide) are allowed. This open-label study consists of a 12-month enrollment phase and a 24-month follow-up phase. During the whole study period, assessments will include monitoring of patient survival, disease progression, and adverse events. A long-term follow-up period will include the collection of rPFS survival and information about new treatments, responses to new treatments, adverse events assessment, as well as blood for hematology and chemistry testing. During follow-up, patients will be contacted every 3 months (+/- 14 Days) via phone, email, or letter for 24 months or until 384 deaths have occurred. An End-of-Treatment (EOT) visit should occur once a participant discontinues study treatment for any reason. This visit should occur within 7 days of the last dose of study treatment or the date the investigator becomes aware of treatment discontinuation (whichever occurs later), but before the initiation of any subsequent anticancer therapy. A Safety Follow-up visit should occur 28 days (+7 days) after the participant's last dose of 177Lu-NYM032 Injection or the date the investigator becomes aware of treatment discontinuation (whichever occurs later), but before the initiation of any subsequent anticancer therapy outside of what is permitted by the study.