Safety and Efficacy Evaluation of Anti IGF-1R Monoclonal Antibody Combined With Anti-PD-1 Monoclonal Antibody in Treatment in Patients With Metastatic Castration-Resistant Prostate Cancer

1. Histologically predominantly other types of prostate cancer, such as sarcomas, lymphomas, small cell tumors, and neuroendocrine tumors;

2. Active infection requiring parenteral antibiotic therapy or causing fever (temperature \> 100.5 o F or 38.1 o C) within 1 week prior to enrollment;

3. have received systemic, ongoing immunosuppressive therapy within 14 days prior to receiving study treatment (except for adrenal replacement steroid doses not exceeding 10 mg prednisone equivalent per day in the absence of active autoimmune disease or short-term steroid therapy (\<5 days) within 7 days prior to initiation of study treatment);

4. Subjects with severe cardiovascular disease;

1. New York Heart Association (NYHA) Stage III or IV congestive heart failure;

2. episode of myocardial infarction or coronary artery bypass grafting (CABG) ≤ 6 months prior to enrollment;

3. clinically significant ventricular arrhythmia, or history of unexplained syncope, non-vasovagal or not due to dehydration;

4. history of severe non-ischemic cardiomyopathy;

5. reduced left ventricular ejection fraction (LVEF \<55%), abnormal septal thickness and atrial size associated with myocardial amyloidosis, as assessed by echocardiography or multigated circuit exploration (MUGA) scan;

5. Organ function is in the following abnormalities:

1. serum aspartate aminotransferase or alanine aminotransferase \> 2.5\*ULN; CK \> \*ULN; CK-MB \> \*ULN; TnT \> 1.5\*ULN;

2. Total bilirubin \> 1.5\*ULN;

3. partial thromboplastin time or activated partial thromboplastin time or international normalized ratio \> 1.5\*ULN in the absence of anticoagulant therapy;

6. Patients who have planned or may plan to undergo extracorporeal radiation therapy or surgery for prostate cancer during the study period;

7. Prior anti-IGF-1R monotherapy and any immune checkpoint inhibitor therapy;

8. Intolerance to anti-IGF-1R monotherapy drugs and immune checkpoint inhibitors;

9. uncontrolled major active infectious disease, cardiovascular disease, pulmonary disease, hematologic disease, or psychiatric disease;

10. In the opinion of the investigator, not suitable for participation in this clinical study;

What this study is about