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 · Status: ACTIVE_NOT_RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 7
Last updated 2025-12-04
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.
Conditions
Interventions
- DRUG
-
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
Sponsors & Collaborators
-
Shanghai Changzheng Hospital
lead OTHER
Principal Investigators
-
Shancheng Ren, MD,PhD · Shanghai Changzheng Hospital
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 85 Years
- Sex
- MALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-03-10
- Primary Completion
- 2025-11-11
- Completion
- 2028-11-30
Countries
- China
Study Locations
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