Subjects with histologically or cytologically confirmed progressive metastatic castration-resistant prostate cancer (mCRPC) with bone metastases.
Conditions
Interventions
Experimental group:KB107 Injection
Sponsors
The affiliated hospital of southwest medical university
Eligibility
Sex/Gender
Male
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Male subjects aged >=18 and =6 months. 4. Histologically or cytologically confirmed diagnosis of prostate cancer. 5. Subjects meeting the definition of castrate-resistant prostate cancer (CRPC). 6. Disease progression despite achieving castrate levels of testosterone. 7. Prior treatment allowing the use of first-generation androgen receptor inhibitors (such as bicalutamide, etc.). 8. Received no more than 2 lines of chemotherapy during the metastatic castrate-resistant prostate cancer (mCRPC) stage. 9. Failure or intolerance to at least one novel hormonal therapy. 10. Diagnosed with multiple bone metastases by bone scan before the first dose administration. 11. Adequate organ and marrow function. 12. For male subjects with reproductive potential and their female partners, effective medical contraceptive measures should be taken during the study treatment period and for 6 months after the end of dosing. 13. Subjects voluntarily participate in this study, sign the informed consent form, and are able to comply with the study visits and related procedures as specified in the protocol.
Exclusion criteria
Exclusion criteria: 1. Received cytotoxic chemotherapy, radical radiotherapy for the primary tumor, bisphosphonate therapy within 4 weeks before the first dose, or planned to receive cytotoxic chemotherapy during the study period. 2. Underwent bone surgery for metastatic bone lesions, major surgery within 4 weeks before the first dose, or planned to undergo major surgery during the study period. 3. Received palliative external beam radiotherapy for metastatic bone lesions within 2 weeks before the first dose. 4. Received or planned to receive hemibody external beam radiotherapy for metastatic bone lesions during the study period. 5. Known to have "superscan" on bone imaging. 6. Received iodine-125 or palladium-103 brachytherapy for the primary tumor within 6 months before the first dose. 7. Had active infections requiring systemic antibiotic therapy within 2 weeks before the first dose. 8. Received prior radionuclide therapy of the same class (e.g., lutetium-177, strontium-89, samarium-153, rhenium-186, rhenium-188, or radium-223). 9. Maximum short-axis diameter of malignant lymph nodes >3 cm. 10. Known history of visceral metastasis. 11. Known pathological fractures, spinal cord compression, or clinical imaging indicating impending pathological fractures or spinal cord compression. 12. Known malignant pleural effusion, pericardial effusion, or ascites. 13. Known history of central nervous system (CNS) metastasis. 14. Presence of severe cardiovascular and cerebrovascular diseases or risk factors. 15. Uncontrolled diabetes (fasting blood glucose >=10 mmol/L on two consecutive occasions) and hypertension. 16. Toxicity from prior anticancer therapy had not resolved to ,<=Grade 1 (based on NCI-CTCAE version 5.0) or to the level specified in the inclusion and exclusion criteria before the first dose. 17. History of other malignancies within 3 years before the first dose (except for cured localized tumors, such as basal cell carcinoma or squamous cell carcinoma of the skin). 18. Subjects with severe and/or uncontrolled comorbid conditions. 19. Active hepatitis B or C. 20. Positive test for human immunodeficiency virus (HIV) or history of acquired immune deficiency syndrome (AIDS). 21. Known active syphilis infection. 22. History of allergy to radionuclides/radioactive drugs or any component of the study medication. 23. Rapid deterioration of condition during screening before the first dose. 24. Currently participating in another clinical study. 25. Presence of any unstable medical condition or clinical situation that, in the opinion of the investigator, would make the subject unsuitable for participation in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The incidence and severity of adverse events (AEs), serious adverse events (SAEs), and clinically significant abnormal laboratory test results, among other factors.;Radiation Dosimetry: Collect biodistribution and radiation dose data for the whole body and major tissues/organs at various time points after drug administration.; | — |
Secondary
| Measure | Time frame |
|---|---|
| Pain Relief Rate: The percentage of the total number of subjects who experienced effective analgesia out of the total number of subjects who underwent pain assessment.;Time to pain progression;Eastern Cooperative Oncology Group (ECOG) performance status (PS) response or progression rate;Survival without new symptomatic bone-related events (SSE-FS);Time to total alkaline phosphatase progression (TTALP);PSA50 response rate;Time to prostate-specific antigen progression (TTPSA);Best Overall Response Rate (BOR);Radiographic progression-free survival (rPFS);Overall Survival (OS); | — |
Countries
China
Contacts
Public ContactChen Yue
The affiliated hospital of southwest medical university
Outcome results
None listed