NCT06866548

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

• Status: Active Not Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 7 (estimated)
• Sponsor: Shanghai Changzheng Hospital · Academic / Other
• Sex: Male
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This trial is designed to primarily confirm the safety and tolerability of anti-IGF-1R mAb (Teprotumumab/IBI311) in combination with anti-PD-1 mAb (Tislelizumab) using the recommended dose level for patients with mCRPC patients. Additionally，this trial is aimed to evaluate the clinical efficacy of anti-IGF-1R mAb combined with anti-PD-1 mAb in the treatment of mCRPC patients and to investigate whether the combined treatment can enhance endocrine therapy sensitivity in mCRPC patients. As for exploratory objectives，the trial is designed to identify and validate predictive biomarkers associated with therapeutic efficacy and safety profiles of the combination regimen in mCRPC patients.

Conditions

• mCRPC

Interventions

Type	Name	Description
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

Timeline

• Start date: 2025-03-10
• Primary completion: 2025-11-11
• Completion: 2028-11-01
• First posted: 2025-03-10
• Last updated: 2025-12-04

Locations

1 site across 1 country: China