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
This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.
About the trial
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
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Mężczyźni z rakiem prostaty (gruczolakiem) potwierdzonym badaniem histologicznym, bez czystej formy drobnkomórkowej
- •Poziom PSA przy badaniu wstępnym ≥4 ng/mL ze wzrostem w ciągu 6 miesięcy przed badaniem
- •Wcześniejsze leczenie co najmniej 2 liniami terapii systemowej zatwierdzonymi do leczenia raka prostaty, w tym: nowoczesne leki antyandrogenne oraz terapia radioaktywna Lu-177-PSMA-617
- •Potwierdzony histologicznie lub cytologicznie rak nerki z składową przezroczystych komórek
- •Zaawansowany rak nerki z co najmniej jednym mierzalnym guzem
- •Wcześniejsza terapia systemowa co najmniej jedną linią, obejmująca leki immunologiczne anty-PD-1/PD-L1
✗ Disqualifies
- •Otrzymanie innego leczenia przeciwnowotworowego w ciągu ostatnich 3 tygodni lub brak pełnego wyleczenia się z poprzednich skutków ubocznych
- •Wcześniejsze inne leki biologiczne w ciągu 5 okresów półtrwania
- •Wcześniejsza terapia biologii molekularnej celującej PSMA (z wyjątkiem Lu-177-PSMA-617)
- •Wcześniejsza immunoterapia przeciwnowotworowa (faza wzrostu dawki) w ciągu 5 okresów półtrwania
- •Potrzeba ciągłego stosowania kortykosteroidów powyżej 10 mg prednizonu dziennie
Simplified criteria — AI translation
Trial details
- Minimum age
- 18 Years
- Last updated (source)
- July 9, 2026
- Sex
- No restrictions
Therapies / drugs in trial
Locations (24)
Banner MD Anderson Cancer Center
Gilbert, United States
Mayo Clinic
Phoenix, United States
University of Arizona
Tucson, United States
John Wayne Cancer Institute (JWCI)
Santa Monica, United States
Sarah Cannon Research Institute (SCRI)
Denver, United States
Yale University Hospital
New Haven, United States
Mayo Clinic Jacksonville
Jacksonville, United States
Moffitt Cancer Center - McKinley Drive
Tampa, United States
Massachusetts General Hospital
Boston, United States
Henry Ford Health
Detroit, United States
Mayo Clinic
Rochester, United States
NYU Langone Health Perlmutter Cancer Center
New York, United States
Icahn School of Medicine at Mount Sinai
New York, United States
Columbia University - The Trustees of Columbia University in the City of New York
New York, United States
Montefiore Medical Center
New York, United States
University of Rochester Medical Center (URMC) - Wilmot Cancer Institute (WCI) (James P. Wilmot Cancer Center) - Rochester
Rochester, United States
James Cancer Hospital and Solove Research Institute
Columbus, United States
Providence Portland Medical Center
Portland, United States
Oregon Health & Science University (3485 S. Bond)
Portland, United States
Thomas Jefferson University Hospital
Philadelphia, United States
Lifespan Cancer Institute
Providence, United States
MD Anderson Cancer Center
Houston, United States
Emily Couric Clinical Cancer Center
Charlottesville, United States
West Virginia University
Morgantown, United States
Trial contact
Clinical Trials Administrator
Contact information from ClinicalTrials.gov. Contact in English.
Share this trial
Data from ClinicalTrials.gov. AI-assisted translation, last sync: 7/10/2026.
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