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RecruitingPhase 1Phase 2NCT03972657

A Trial to Find Out if REGN5678 (Nezastomig) is Safe and How Well it Works Alone or in Combination With Cemiplimab for Adult Participants With Metastatic Castration-Resistant Prostate Cancer and Other Tumors

A Phase 1/2 Study of REGN5678 (Anti-PSMAxCD28) With or Without Cemiplimab (Anti-PD-1) in Patients With Metastatic Castration-Resistant Prostate Cancer and Other Tumors Associated With PSMA Expression

Sponsor

Regeneron Pharmaceuticals

Enrollment

345 participants

Start Date

Aug 12, 2019

Study Type

INTERVENTIONAL

Conditions

Metastatic Castration-resistant Prostate Cancer (mCRPC)Clear-Cell Renal-Cell Carcinoma (ccRCC)

Summary

The main purpose of this study is to determine the safety, tolerability (how the body reacts to the drug\[s\]) and effectiveness (ability to treat the cancer) of REGN5678 (Nezastomig) alone, or in combination with cemiplimab. The study has 2 parts. The goal of Part 1 (dose escalation) is to determine a safe dose(s) of REGN5678 when it is given alone or in combination with cemiplimab. The goal of Part 2 (dose expansion) is to use the REGN5678 drug dose(s) found in Part 1 to see how well REGN5678 alone or in combination with cemiplimab works to shrink tumors. This study is looking at several other research questions, including: 1. Side effects that may be experienced by taking REGN5678 alone or in combination with cemiplimab 2. How REGN5678 alone or in combination with cemiplimab works in the body 3. How much REGN5678 and/or cemiplimab are present in the blood 4. To see if REGN5678 alone or in combination with cemiplimab works to reduce the size of the tumor by helping the immune system destroy the tumor

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests an experimental drug called REGN5678 (nezastomig) alone or combined with cemiplimab (an immunotherapy) in men with advanced prostate cancer that no longer responds to hormone therapy, and in patients with advanced kidney cancer (clear cell type). **You may be eligible if...** - (Prostate cancer) You are a man with confirmed prostate adenocarcinoma, a PSA level of 4 or higher that has risen in the past 6 months, and you have already tried at least 2 standard therapies including a second-generation anti-androgen and a lutetium-based treatment - (Kidney cancer) You have confirmed clear cell renal cell carcinoma that has progressed or is not responding to prior treatment **You may NOT be eligible if...** - You have pure small cell prostate cancer - You have not received the required prior therapies - Your overall health or organ function does not meet study requirements 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

Administered as per the protocol

DRUGCemiplimab

Administered as per the protocol

Locations(21)

Banner MD Anderson Cancer Center

Gilbert, Arizona, United States

Mayo Clinic

Phoenix, Arizona, United States

University of Arizona

Tucson, Arizona, United States

John Wayne Cancer Institute (JWCI)

Santa Monica, California, United States

Sarah Cannon Research Institute (SCRI)

Denver, Colorado, United States

Yale University Hospital

New Haven, Connecticut, United States

Mayo Clinic Jacksonville

Jacksonville, Florida, United States

Moffitt Cancer Center - McKinley Drive

Tampa, Florida, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Mayo Clinic

Rochester, Minnesota, United States

NYU Langone Health Perlmutter Cancer Center

New York, New York, United States

Icahn School of Medicine at Mount Sinai

New York, New York, United States

Columbia University - The Trustees of Columbia University in the City of New York

New York, New York, United States

Montefiore Medical Center

New York, New York, United States

University of Rochester Medical Center (URMC) - Wilmot Cancer Institute (WCI) (James P. Wilmot Cancer Center) - Rochester

Rochester, New York, United States

Providence Portland Medical Center

Portland, Oregon, United States

Oregon Health & Science University (3485 S. Bond)

Portland, Oregon, United States

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, United States

Lifespan Cancer Institute

Providence, Rhode Island, United States

MD Anderson Cancer Center

Houston, Texas, United States

Emily Couric Clinical Cancer Center

Charlottesville, Virginia, United States

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NCT03972657

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