Substudy 01A: Safety and Efficacy of Opevesostat (MK-5684)-Based Treatment Combinations or Opevesostat Alone in Participants With Metastatic Castration-resistant Prostate Cancer (mCRPC) (MK-5684-01A)
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
Substudy 01A is part of a larger research study that is testing experimental treatments for metastatic castration-resistant prostate cancer (mCRPC). The larger study is the umbrella study (U01). The goal of substudy 01A is to evaluate the safety and efficacy of opevesostat-based treatment combinations, or as a single agent, in participants with mCRPC. This substudy will have two phases: a safety lead-in phase and an efficacy phase. The safety lead-in phase will be used to evaluate the safety and tolerability, and to establish a recommended Phase 2 dose (RP2D) for the opevesostat-based treatment combinations. There will be no hypothesis testing in this study.
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Potwierdzony nowotwór gruczołowy prostaty
- •Rak prostaty przerzutowy (rozprzestrzeniający się na inne części ciała)
- •Poprzednie leczenie hormonalne nie zadziałało lub przestało działać
- •Leczenie lekami zmniejszającymi androgenę (hormony płciowe) rozpoczęte w ciągu 6 miesięcy
- •Poprzednie leczenie 1-2 nowymi lekami hormonalnymi
- •HIV dodatni - tylko jeśli dobrze kontrolowany lekami
- •Zapalenie wątroby typu B - tylko jeśli przyjmuje leki i wirus jest niewykrywalny
- •Zapalenie wątroby typu C - tylko jeśli wirus jest niewykrywalny
✗ Disqualifies
- •Zaburzenia pracy przysadki mózgowej
- •Niekontrolowana cukrzyca
- •Aktywne problemy z sercem lub naczyniami krwionośnymi w ostatnich 6 miesiącach
- •Zawał serca w ostatnich 6 miesiącach
Simplified criteria — AI translation
Trial details
- Minimum age
- 18 Years
- Last updated (source)
- October 6, 2026
- Sex
- No restrictions
Therapies / drugs in trial
Locations (77)
UCSD Moores Cancer Center ( Site 0039)
La Jolla, United States
UCLA Hematology/Oncology - Santa Monica ( Site 0044)
Los Angeles, United States
University of Miami Hospital and Clinics, Sylvester Cancer Center-Cancer Research Services ( Site 0051)
Miami, United States
University of Maryland-Greenebaum Comprehensive Cancer Center ( Site 0049)
Baltimore, United States
Rutgers Cancer Institute of New Jersey ( Site 0033)
New Brunswick, United States
University Hospitals Cleveland Medical Center ( Site 0043)
Cleveland, United States
MEDICAL COLLEGE OF WISCONSIN-Cancer Center Clinical Trials Office ( Site 0020)
Milwaukee, United States
Macquarie University-MQ Health Clinical Trials Unit ( Site 0108)
Macquarie University, Australia
Gallipoli Medical Research Ltd-GMRF CTU ( Site 0107)
Greenslopes, Australia
Peter MacCallum Cancer Centre-Parkville Cancer Clinical Trials Unit (PCCTU) ( Site 0110)
Melbourne, Australia
Centre Hospitalier de l'Université de Montréal ( Site 0200)
Montreal, Canada
Jewish General Hospital ( Site 0206)
Montreal, Canada
Centre intégré de cancérologie du CHU de Québec Université Laval, Hôpital de l'Enfant-Jésus ( Site 0207)
Québec, Canada
CIDO SpA-Oncology ( Site 0302)
Temuco, Chile
Clinica Universidad Catolica del Maule-Oncology ( Site 0304)
Talca, Chile
Fundación Arturo López Pérez ( Site 0301)
Santiago, Chile
Pontificia Universidad Catolica de Chile ( Site 0303)
Santiago, Chile
Bradfordhill ( Site 0300)
Santiago, Chile
FUNDACION CTIC CENTRO DE TRATAMIENTO E INVESTIGACION SOBRE CANCER LUIS CARLOS SARMIENTO ANGULO ( Site 0406)
Bogotá, Colombia
Clinica Colsanitas S.A, Sede Clínica Universitaria Colombia ( Site 0402)
Bogotá, Colombia
Sociedad De Oncología y Hematología Del Cesar SAS-Oncology ( Site 0400)
Valledupar, Colombia
IMAT S.A.S ( Site 0404)
Montería, Colombia
Fundación Valle del Lili-Oncology CIC ( Site 0403)
Cali, Colombia
Herlev and Gentofte Hospital ( Site 0501)
Copenhagen, Denmark
Aalborg Universitetshospital, Syd ( Site 0503)
Aalborg, Denmark
Vaasan Keskussairaala ( Site 0603)
Vaasa, Finland
Helsinki University Hospital - Comprehensive Cancer Center (HYKS - Syöpäkeskus) ( Site 0604)
Helsinki, Finland
Docrates Syöpäsairaala ( Site 0602)
Helsinki, Finland
Institut Bergonié - Centre Régional de Lutte Contre Le Cancer de Bordeaux et Sud Ouest ( Site 0703)
Bordeaux, France
Hopitaux Universitaires de Strasbourg ( Site 0700)
Strasbourg, France
Hôpital Européen Georges Pompidou-Service d'Oncologie Médicale ( Site 0702)
Paris, France
Gustave Roussy ( Site 0701)
Villejuif, France
Universitaetsklinikum Heidelberg ( Site 0805)
Heidelberg, Germany
Universitaetsklinikum Tuebingen-Urologie ( Site 0801)
Tübingen, Germany
klinikum rechts der isar der technischen universität münchen-Urologische Klinik und Poliklinik ( Site 0802)
Munich, Germany
Charité Universitaetsmedizin Berlin - Campus Mitte ( Site 0800)
Berlin, Germany
Universitaetsklinikum Hamburg-Eppendorf-Onkologisches Zentrum ( Site 0804)
Hamburg, Germany
St. Vincent's University Hospital ( Site 0901)
Dublin, Ireland
Cork University Hospital ( Site 0902)
Cork, Ireland
Tallaght University Hospital ( Site 0900)
Dublin, Ireland
Rambam Health Care Campus-Oncology Division ( Site 1002)
Haifa, Israel
Rabin Medical Center ( Site 1001)
Petah Tikva, Israel
Sheba Medical Center ( Site 1000)
Ramat Gan, Israel
Fondazione Policlinico Universitario Agostino Gemelli IRCCS -Medical Oncology ( Site 1102)
Rome, Italy
Fondazione IRCCS Istituto Nazionale dei Tumori-Struttura Complessa Oncologia Medica 1 ( Site 1103)
Milan, Italy
Istituto Clinico Humanitas-U.O di Oncologia medica ed Ematologia ( Site 1101)
Rozzano, Italy
Azienda Ospedaliera Universitaria Integrata Verona - Ospedal-Centro Ricerche Cliniche di Verona ( Site 1100)
Verona, Italy
Toho University Sakura Medical Center ( Site 1201)
Sakura, Japan
Yokohama City University Medical Center ( Site 1203)
Yokohama, Japan
The Jikei University Hospital ( Site 1202)
Mitato, Japan
Kyushu University Hospital ( Site 1204)
Fukuoka, Japan
Auckland City Hospital ( Site 1333)
Auckland, New Zealand
Centrum Onkologii im. Prof. Franciszka Lukaszczyka ( Site 1402)
Bydgoszcz, Poland
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Oddzial Badan Wczesnych Faz ( Site 1400)
Warsaw, Poland
Uniwersyteckie Centrum Kliniczne ( Site 1405)
Gdansk, Poland
Asan Medical Center-Oncology ( Site 1500)
Songpagu, South Korea
Severance Hospital, Yonsei University Health System-Medical oncology ( Site 1502)
Seoul, South Korea
Samsung Medical Center-Division of Hematology/Oncology ( Site 1501)
Seoul, South Korea
Institut Català d'Oncologia - L'Hospitalet-Medical Oncology ( Site 1603)
L'Hospitalet de Llobregat, Spain
Hospital Universitario Ramón y Cajal-Medical Oncology ( Site 1600)
Madrid, Spain
Hospital Universitari Vall d'Hebron-Departamento de Oncologia- VHIO ( Site 1602)
Barcelona, Spain
Hospital General Universitario Gregorio Marañón ( Site 1601)
Madrid, Spain
Hospital Clinico San Carlos-Oncology Department ( Site 1604)
Madrid, Spain
Chang Gung Memorial Hospital at Kaohsiung-Oncology and Hematology ( Site 1704)
Kaohsiung Niao Sung Dist, Taiwan
China Medical University Hospital ( Site 1703)
Taichung, Taiwan
Taipei Veterans General Hospital ( Site 1701)
Taipei, Taiwan
Chang Gung Medical Foundation-Linkou Branch-Medical Oncology ( Site 1702)
Taoyuan, Taiwan
Baskent University Dr. Turgut Noyan Research and Training Center-ONCOLOGY ( Site 1802)
Adana, Turkey (Türkiye)
Hacettepe Universite Hastaneleri-oncology hospital ( Site 1800)
Ankara, Turkey (Türkiye)
Ankara Bilkent Şehir Hastanesi ( Site 1801)
Ankara, Turkey (Türkiye)
Istanbul Universitesi Cerrahpasa-Medical Oncology ( Site 1804)
Istanbul, Turkey (Türkiye)
TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi-oncology ( Site 1803)
Istanbul, Turkey (Türkiye)
Addenbrooke's Hospital ( Site 1902)
Cambridge, United Kingdom
The Beatson West of Scotland Cancer Centre ( Site 1904)
Glasgow, United Kingdom
Royal Preston Hospital-Lancashire Clinical Research Facility ( Site 1900)
Preston, United Kingdom
University College London Hospital ( Site 1905)
London, United Kingdom
Queen Elizabeth Hospital Birmingham ( Site 1903)
Birmingham, United Kingdom
Trial contact
Toll Free Number
Contact information from ClinicalTrials.gov. Contact in English.
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Data from ClinicalTrials.gov. AI-assisted translation, last sync: 9/4/2026.
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