RecruitingPhase 1Phase 2NCT05125016

A Trial to Find Out if REGN4336 is Safe and How Well it Works Alone and in Combination With Cemiplimab or REGN5678 for Adult Participants With Advanced Prostate Cancer

Phase 1/2 Study of REGN4336 (a PSMAxCD3 Bispecific Antibody) Administered Alone or in Combination With Cemiplimab or REGN5678 (a PSMAxCD28 Bispecific Antibody) in Patients With Metastatic Castration-Resistant Prostate Cancer


Sponsor

Regeneron Pharmaceuticals

Enrollment

370 participants

Start Date

Nov 30, 2021

Study Type

INTERVENTIONAL

Conditions

Summary

This study is researching an investigational drug called REGN4336. Some participants may receive additional investigational drugs in combination with REGN4336. These additional drugs include REGN5678, cemiplimab and sarilumab. The main purpose of this study is to determine the safety, tolerability (how the body reacts to the drug) and effectiveness of REGN4336 alone, in combination with cemiplimab, or in combination with REGN5678. REGN4336, cemiplimab and REGN5678 are a type of treatment for cancer called immunotherapy,and are intended to activate T-cells to attack cancer cells. This study has 2 parts. The purpose of Part 1 is to determine a safe dose of REGN4336 when given alone or when given in combination with cemiplimab or REGN5678. The purpose of Part 2 is to use the REGN4336 dose(s) determined in Part 1 to further test how well REGN4336 works to shrink tumors either when given alone or in combination with cemiplimab or REGN5678. This study is looking at several other research questions, including: * What side effects may happen from taking REGN4336 alone, in combination with cemiplimab, or in combination with REGN5678? * How much REGN4336 is in the blood at different times when it is given alone, in combination with cemiplimab, or in combination with REGN5678? * Does the body make antibodies against the study drugs (REGN4336, cemiplimab, or REGN5678)?


Eligibility

Sex: MALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing a new drug called REGN4336 — alone and combined with either cemiplimab (an immunotherapy) or REGN5678 (another investigational drug) — in men with advanced prostate cancer that has stopped responding to hormone therapy (metastatic castration-resistant prostate cancer). REGN4336 is a bispecific antibody designed to direct immune T cells to attack prostate cancer cells. **You may be eligible if...** - You are 18 or older with confirmed metastatic castration-resistant prostate cancer (not pure small-cell type) - Your PSA is at least 4 ng/mL and rising, or you have measurable disease progression on scans - You have progressed on at least 2 prior lines of therapy including at least one second-generation anti-androgen (like enzalutamide or abiraterone) - You are in adequate general health with organ function meeting study requirements **You may NOT be eligible if...** - You have small cell or neuroendocrine prostate cancer - You have active brain metastases or leptomeningeal disease - You have autoimmune conditions requiring systemic treatment - You have had certain prior treatments (PSMA-targeted therapy, prior bispecific antibodies) - You are on immunosuppressive therapy 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

DRUGREGN4336

Administered once weekly (QW) by subcutaneous (SC) injection, or intravenous (IV) infusion

DRUGCemiplimab

Administered concomitantly every 3 weeks (Q3W) by IV infusion

DRUGREGN5678

Administered concomitantly QW by IV infusion

DRUGSarilumab

Administered once by IV infusion as prophylaxis prior to REGN4336 IV


Locations(14)

Stanford University Medical Center - Blake Wilbur Drive

Palo Alto, California, United States

Yale University Hospital

New Haven, Connecticut, United States

Norton Cancer Institute

Louisville, Kentucky, United States

University of Maryland Greenebaum Cancer Center

Baltimore, Maryland, United States

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, United States

Roswell Park Cancer Institute

Buffalo, New York, United States

Atrium Health Levine Cancer Institute

Charlotte, North Carolina, United States

The Ohio State University James Cancer Hospital

Columbus, Ohio, United States

Penn Medicine University of Pennsylvania Health System

Philadelphia, Pennsylvania, United States

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, United States

Fox Chase Cancer Center

Philadelphia, Pennsylvania, United States

Fox Chase Cancer Center

Philadelphia, Pennsylvania, United States

MD Anderson Cancer Center

Houston, Texas, United States

Medical College of Wisconsin

Milwaukee, Wisconsin, United States

View Full Details on ClinicalTrials.gov

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NCT05125016


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