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MGF Igf-1-ec

IGF-1Ec, IGF-1Eb, Mechano-Growth Factor

Quick Stats
Studies 62
Trials 100
Overview Studies Clinical Trials
Active Not Recruiting EARLY PHASE1 INTERVENTIONAL 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

View on ClinicalTrials.gov Updated Dec 15, 2025

Brief 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.

Interventions

Name: anti-IGF-1R mAb (Teprotumumab/IBI311) + anti-PD-1 mAb (Tislelizumab)
Type: DRUG
Description: 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

Primary Outcomes

Measure: Safety and adverse event incidence rate
TimeFrame: Through primary completion of study which may take up to 6 months.
Description: Incidence rate of adverse events graded according to the National Cancer Institute Common Criteria for Adverse Events (NCI CTCAE) version 5.0.

Trial Information

NCT ID

NCT06866548

Status

Active Not Recruiting

Study Type

INTERVENTIONAL

Phases

EARLY PHASE1

Sponsor

Shanghai Changzheng Hospital

Last Updated

December 15, 2025