Study of [177Lu] Lu-XT033 Injection in Patients With Metastatic Prostate Cancer

Launched by SINOTAU PHARMACEUTICAL GROUP · Oct 7, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called [177Lu] Lu-XT033 injection for patients with metastatic prostate cancer, which means the cancer has spread beyond the prostate gland. The trial aims to understand how safe and effective this treatment is, as well as how it behaves in the body. It is open to male patients aged 18 to 80 who have been diagnosed with prostate cancer and have had previous treatments. Participants must be able to give their consent and should be in relatively good health with a life expectancy of over six months.

If you choose to take part in this study, you will receive the [177Lu] Lu-XT033 injection and will be monitored closely for any side effects and how well the treatment works for you. To be eligible, you should have specific test results confirming your cancer diagnosis and have received certain prior treatments. It’s important to note that there are some conditions that would exclude someone from participating, such as having certain other cancers or recent treatments that could interfere with this study. Overall, this trial offers a potential new option for managing metastatic prostate cancer, and participants will contribute to valuable research that could help others in the future.

Gender

MALE

Eligibility criteria

• Inclusion Criteria:
• • 1. Patients must have the ability to understand and sign an approved informed consent form (ICF).
• • 2. Patients must be \>= 18 and \<＝80 years of age.
• • 3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• • 4. Patients must have a life expectancy \>6 months.
• • 5. Patients must have histological, pathological, and/or cytological confirmation of prostate cancer.
• • 6. Patients must be 68Ga-PSMA-11 Positron Emission Tomography (PET)/Computed Tomography (CT) scan positive。
• • 7. Patients must have a castrate level of serum/plasma testosterone (\<50 ng/dL or \<1.7 nmol/L).
• • 8. Patients must have received at least one NAAD (such as enzalutamide and/or abiraterone)； Patients must have been previously treated with at least 1, but no more than 2 previous taxane regimens.
• • 9. Patients must have progressive mCRPC.
• • 10. Patients must have adequate organ function。
• • 11. Subjects of childbearing potential voluntarily use an effective method of contraception, such as condoms, oral or injectable contraceptives, Intra-uterine device（IUD）,etc., during treatment and within 6 months of the last use of the trial drug.
• Exclusion Criteria:
• • 1. Previous treatment with any of the following within 6 months of enrollment: Strontium-89, Samarium-153, Rhenium-186, Rhenium-188, Radium-223, hemi-body irradiation. Previous PSMA-targeted radioligand therapy is not allowed.
• • 2. Known other malignancies.
• • 3. Any systemic anti-cancer therapy (e.g. chemotherapy, immunotherapy or biological therapy within 28 days prior to day of enrollment.
• • 4. Known hypersensitivity to the components of the study therapy or its analogs.
• • 5. A superscan as seen in the baseline bone scan.
• • 6. Patients with a history of Central Nervous System (CNS) metastases.
• • 7. Uncontrolled, intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, cardiac arrhythmia, or other severe complications.