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
Recruiting now · Phase 1/Phase 2
Conditions studied: Metastatic Castration-Resistant Prostate Cancer (mCRPC), Clear Cell Renal Cell Carcinoma (ccRCC)
In brief
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
Key facts
- Study ID
- NCT03972657
- Run by
- Regeneron Pharmaceuticals
- People needed
- 345
- Starts
- 2019-08-12
- Expected to finish
- 2027-11-15
- Last updated by the study team
- 2026-07-09
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- West Virginia University — Morgantown, West Virginia, United States (enrolling)
- Mayo Clinic — Phoenix, Arizona, United States (enrolling)
- University of Arizona — Tucson, Arizona, United States (enrolling)
- John Wayne Cancer Institute (JWCI) — Santa Monica, California, United States (enrolling)
- Sarah Cannon Research Institute (SCRI) — Denver, Colorado, United States (enrolling)
- Yale University Hospital — New Haven, Connecticut, United States (enrolling)
- Mayo Clinic Jacksonville — Jacksonville, Florida, United States (enrolling)
- Moffitt Cancer Center - McKinley Drive — Tampa, Florida, United States (enrolling)
- Massachusetts General Hospital — Boston, Massachusetts, United States (enrolling)
- Henry Ford Health — Detroit, Michigan, United States (enrolling)
- Mayo Clinic — Rochester, Minnesota, United States (enrolling)
- NYU Langone Health Perlmutter Cancer Center — New York, New York, United States (enrolling)
- Icahn School of Medicine at Mount Sinai — New York, New York, United States (enrolling)
- Columbia University - The Trustees of Columbia University in the City of New York — New York, New York, United States (enrolling)
- Montefiore Medical Center — New York, New York, United States (enrolling)
- University of Rochester Medical Center (URMC) - Wilmot Cancer Institute (WCI) (James P. Wilmot Cancer Center) - Rochester — Rochester, New York, United States (enrolling)
- James Cancer Hospital and Solove Research Institute — Columbus, Ohio, United States (enrolling)
- Banner MD Anderson Cancer Center — Gilbert, Arizona, United States (enrolling)
- Oregon Health & Science University (3485 S. Bond) — Portland, Oregon, United States (enrolling)
- Thomas Jefferson University Hospital — Philadelphia, Pennsylvania, United States (enrolling)
- Lifespan Cancer Institute — Providence, Rhode Island, United States (enrolling)
- MD Anderson Cancer Center — Houston, Texas, United States (enrolling)
- Emily Couric Clinical Cancer Center — Charlottesville, Virginia, United States (enrolling)
- Providence Portland Medical Center — Portland, Oregon, United States
Full record on ClinicalTrials.gov
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