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Clinical Trials in China / NCT06866548
Active, not recruiting Phase EARLY_PHASE1

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

NCT06866548 · tracked via the Priya Life Science China tracker
Sponsor
Shanghai Changzheng Hospital
Phase
Phase EARLY_PHASE1
Started
2025-03-10
Last updated
2026-07-23

Condition(s) studied

mCRPC

Investigational drug(s) / intervention(s)

anti-IGF-1R mAb (Teprotumumab/IBI311) + anti-PD-1 mAb (Tislelizumab)

anti-IGF-1R mAb (Teprotumumab/IBI311) + anti-PD-1 mAb (Tislelizumab): Drug: Teprotumumab/IBI311 Given by IV infusion Initiate dosing with 10 mg/kg for first infusion, followed by 20 mg/kg every 3 weeks. Drug: Tislelizumab Given by IV infusion 200 mg every 3 weeks

Study summary

This trial is designed to evaluate the safety and efficacy of anti-IGF-1R mAb in combination with anti-PD-1 mAb in patients with mCRPC.

Eligibility

Sex
MALE
Min age
18 Years
Max age
85 Years
Healthy volunteers
No
Inclusion Criteria: 1. Men over 18 years old and under 85 years old; 2. Diagnosed with prostate adenocarcinoma by prostate biopsy pathology report; 3. Patients with metastatic castration-resistant prostate adenocarcinoma (mCRPC); 4. evidence of metastatic bone lesions on imaging such as PSMA-PET-CT or bone metastasis imaging ECT; 5. Serum testosterone in the depot range (\< 50 ng/dL or 1.75 nmol/L); 6. Patients need to be willing to undergo pre- and on-treatment biopsy; 7. ECOG score ≤ 2; 8. Expected survival time of 6 months or more; 9. Substantially normal bone marrow, liver and kidney function: 1. white blood cell (WBC) \> 3 x 10\^9 cells/L 2. Absolute neutrophil count (ANC) \> 1×10\^9 cells/L 3. Hemoglobin \>9.0 g/dL 4. Platelet count \>100×10\^9/L 5. Serum creatinine \<1.5 × upper limit of normal (ULN) 6. Serum total bilirubin \<1.5 × ULN 7. Serum glutamine aminotransferase \<3 × ULN 8. Aspartate aminotransferase \<3 × ULN 10. willingness to cooperate and complete study follow-up and related tests. 11. The subject or his/her representative voluntarily participates in the study and signs a written informed consent; and 12. The questionnaire can be completed in Chinese. 13. The patient has been informed of the trial; Exclusion Criteria: 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;

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Shanghai Changzheng Hospital Shanghai Shanghai Municipality

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06866548 on ClinicalTrials.gov ↗ ← All trials in China