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.
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.
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.
Sequential
Lutetium Lu 177 JH020002 Injection
DrugPatients will receive Lutetium Lu 177 JH020002 Injection every 6 weeks for a maximum of 6 doses. Doses range between 1.85 and 8.88 GBq (50-240 mCi)
Dose Limiting Toxicity (DLT) (Phase 1)
Incidence of adverse events, serious adverse events, and clinical laboratory abnormalities defined as dose-limiting toxicities (DLTs).
Maximum Tolerated Dose (MTD) (Phase 1)
The maximum tolerated dose is among the explored dose levels.
Recommended Phase 2 Dose (RP2D) (Phase 1)
To identify the expansion phase dose of Lutetium Lu 177 JH020002 Injection.
PSA response rate
PSA response rate is the proportion of PSA responders, defined as a participant who has achieved PSA decrease of \>= 50% from baseline that is confirmed by a second consecutive PSA measurement \>= 4 weeks later. Determination of response status will be based on PCWG3 recommendations.
Radiation Dosimetry
Absorbed dose estimated in organs and tumor lesions.
Maximum plasma concentration (Cmax)
Pharmacokinetics (PK) characterization of Lutetium Lu 177 JH020002.
Time to maximum plasma concentration (Tmax)
Pharmacokinetics (PK) characterization of Lutetium Lu 177 JH020002.
Terminal elimination half-life (t1/2)
Pharmacokinetics (PK) characterization of Lutetium Lu 177 JH020002.
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