Metastatic Castration-resistant Prostate Neoplasms
Conditions
Interventions
Experimental group:Pasritamig + Best Supportive Care (BSC)
Control group:Placebo+ Best Supportive Care (BSC)
Sponsors
Fudan University Shanghai Cancer Center
Eligibility
Sex/Gender
Male
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. When signing the informed consent form, the individual must be at least 18 years old (or reach the legal age of adulthood recognized by the country/region where the study is conducted). 2. Histologically diagnosed as prostate adenocarcinoma. 3. mCRPC: At the time of screening, there must be bone metastasis and/or any lymph node metastasis, and there must be no clear evidence of internal organ metastasis. The PSA at screening must be >= 2 ng/mL. 4. The PSA at screening must be >= 2 ng/mL. 5. The investigator believes that the clinical trial is the most appropriate next treatment option. 6. The subject must have received all treatments deemed clinically appropriate by the investigator and available for prolonging life. Previous treatments can be used to treat any disease stage (not limited to mCRPC). 7. At least 2 weeks must be discontinued from any other anti-cancer treatment or investigational drugs before the first administration of the study drug. 8. The subject must have undergone adequate recovery from any recent surgery or trauma. 9. The laboratory test indicators of renal function, liver function, and hematology must be within the required range. 10. The ECOG performance status score must be 0-2. 11. Renal function, liver function, and hematological laboratory test indicators must be within the required range. 12. The subject must agree to comply with the following requirements during the study treatment and within 3 months after the last administration of the study treatment: • Not to donate gametes (i.e., sperm) or freeze gametes for future use in assisted reproduction. • When there is a possibility of sperm transmission/sperm ejaculation, an external condom must be worn. • If the subject can produce sperm and the female partner has fertility, the female partner must adopt an effective contraceptive method. 13. The subject must sign the informed consent form (ICF), indicating that they understand the purpose of the study and the required procedures, and are willing to participate in this study. 14. The subject must be willing and able to follow the lifestyle restriction requirements stipulated in the study protocol.
Exclusion criteria
Exclusion criteria: 1. Have received organ transplantation or bone marrow transplantation. 2. The study treatment is for the first administration within 1 month before the occurrence of venous thromboembolic events (such as pulmonary embolism) during the first administration; simple ( 2 L/min) to maintain adequate oxygenation. 6. Suspected or known to be allergic, hypersensitive or intolerant to the excipients of Pasritamig (refer to the latest version of Pasritamig IB). 7. The subject had or had concurrent a second malignant tumor (excluding the study disease), and its natural course or treatment may interfere with any study safety endpoint or the efficacy of the study treatment. 8. Had cardiovascular system diseases within 6 months before the first administration of the study treatment. 9. Has a history of brain or meningeal prostate cancer metastasis. 10. Has known HIV positivity and meets the laboratory test values defined in the protocol. 11. Has active or chronic hepatitis B virus (HBV) or hepatitis C virus (HCV) infection. 12. Has received KLK2 targeted therapy before. 13. Has received any CD3 targeted therapy before. 14. Has received immunosuppressive doses of systemic drugs within 3 days before the first administration of the study treatment, such as glucocorticoids (dose > 10 mg/day prednisone or equivalent drugs). 15. Has received any live attenuated vaccine or plans to receive any live attenuated vaccine within 4 weeks before the first administration of the study treatment. Live attenuated influenza vaccine can be administered at the latest 7 days before the study treatment. 16. Any serious underlying disease or other issues that may impair the subject's ability to receive or tolerate the planned treatment, understand the informed consent form, or any condition that the investigator considers not in the best interests of the subject (such as harming health), or any condition that may hinder, limit or confuse the assessment as stipulated in the study protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall Survival (OS); | — |
Secondary
| Measure | Time frame |
|---|---|
| Number of Participants with Abnormalities in Clinical Laboratory Assessments;Time to Deterioration in Fatigue;Progression-Free Survival (PFS);Time to Pain Progression (TTPP);Radiographic Progression-free Survival (rPFS);Time to Skeletal-Related Event;Time to Prostate Specific Antigen (PSA) Progression;Number of Participants with Adverse Events (AEs);Time to Symptomatic Progression; | — |
Countries
China
Contacts
Public ContactYe Dingwei
Fudan University Shanghai Cancer Center
Outcome results
None listed