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

Phase 1/2 Clinical Study to Evaluate the Safety, Tolerability, Radiation Dosimetry and Preliminary Efficacy of Lutetium Lu 177 JH020002 Injection in Patients With Advanced Prostate Cancer

The study is being conducted to evaluate the safety, tolerability, pharmacokinetics, radiation dosimetry, and preliminary efficacy of Lutetium Lu 177 JH020002 Injection in adult patients with advanced prostate cancer.

Inclusion Criteria:

• 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).

Exclusion Criteria:

• 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.
• 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.
• History of hypersensitivity to any of the study drugs or its excipients or to drugs of similar chemical classes.