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

Launched by BIVISION PHARMACEUTICALS, INC. · Nov 14, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called Lutetium Lu 177 JH020002 Injection for men with advanced prostate cancer. The goal of the study is to find out how safe the treatment is, how well it works, and to learn more about how the body processes the medication. Researchers want to know if it can help patients with this type of cancer and how it affects their health.

To participate in this trial, men must be at least 18 years old and have a specific type of prostate cancer confirmed by medical tests. They should also have a good performance status, meaning they are generally healthy and can carry out daily activities. Participants need to have a life expectancy of more than six months and must meet certain health criteria regarding hormone levels and previous cancer treatments. If you join the study, you will receive the Lutetium injection and be monitored closely by healthcare professionals to keep track of your health and any side effects. This trial is currently looking for volunteers, so if you or a loved one are interested, it's a good idea to talk to your doctor for more information.

Gender

MALE

Eligibility criteria

• 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.