RecruitingPhase 1NCT06826768

A Ph Ib Study of REGN5678 Plus Cemiplimab in Patients With mCRPC

A Phase Ib Clinical Trial to Optimize Risk Benefit of REGN5678 (PSMAxCD28 Bispecific Antibody) Plus Cemiplimab (Anti-PD-1 Monoclonal Antibody) in Patients With Metastatic Castration-resistant Prostate Cancer


Sponsor

M.D. Anderson Cancer Center

Enrollment

60 participants

Start Date

Jul 9, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

A single-center phase Ib/II dose escalation and dose-expansion clinical trial of REGN5678 plus cemiplimab


Eligibility

Sex: MALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing REGN5678 (a bispecific antibody that targets both PSMA on prostate cancer cells and CD28 on immune cells) combined with cemiplimab (an immunotherapy drug) in men with metastatic prostate cancer that is no longer responding to hormone therapy. **You may be eligible if...** - You are 18 or older and male - You have metastatic castration-resistant prostate cancer (mCRPC — prostate cancer that has spread and is not responding to standard hormone therapy) - Your cancer has progressed despite prior treatments - You have measurable disease or rising PSA - Your organ function and blood counts are within acceptable ranges **You may NOT be eligible if...** - You have active autoimmune disease - You have significant brain metastases - You have received prior immunotherapy targeting PSMA - You are on chronic immunosuppressive steroids - You have active serious infections Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGREGN5678

Given by IV infusion

DRUGCemiplimab

Given by IV infusion


Locations(1)

The University of Texas M. D. Anderson Cancer Center

Houston, Texas, United States

View Full Details on ClinicalTrials.gov

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NCT06826768


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