Phase 1/2 Clinical Study of Lutetium Lu 177 JH020002 Injection in Patients With Advanced Prostate Cancer

Prior treatment

• Participants with a history of central nervous system (CNS) metastases who are neurologically unstable, symptomatic, or receiving corticosteroids for the purpose of maintaining neurologic integrity.
• Previous treatment with Strontium-89, Samarium-153, Rhenium-186, Rhenium-188, Radium-223 or hemi-body irradiation \<6 months prior to date of first administration of investigational drug.
• Previous PSMA-targeted radioligand therapy.
• Previous radiotherapy for prostate cancer within 4 weeks prior to date of first administration of investigational drug.
• Any systemic anti-cancer therapy (e.g. chemotherapy, immunotherapy, poly adenosine diphosphate-ribosyl polymerase inhibitors (PARPi) or biological therapy within 4 weeks prior to date of first administration of investigational drug.
• Must not take part in other investigational therapies within 4 weeks prior to date of first administration of investigational drug.

Other illness

• Diagnosed with other malignancies, apart from: adequately treated skin basal cell carcinoma or superficial bladder cancers from which the patient has been disease-free for more than 3 years as confirmed by a physician.
• History of hypersensitivity to any of the study drugs or its excipients or to drugs of similar chemical classes.

• Subjects are required to get informed consent prior to the trial and sign a written informed consent form voluntarily.
• Male, age ≥18 years.
• ECOG score 0 - 2.
• Must have a life expectancy \>6 months.
• Histologically and/or cytologically confirmed adenocarcinoma of the prostate (except for those with neuroendocrine or small cell prostate cancer clinical features).
• Participants must have a castrate level of serum/plasma testosterone (\< 50 ng/dl, or \< 1.7nmol/L).