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A Clinical Study of Ifinatamab Deruxtecan Based Treatment Combinations or as Monotherapy to Treat Metastatic Castrate Resistant Prostate Cancer (mCRPC) (MK-2400-01A/IDeate-Prostate02)
Sponsor: Merck Sharp & Dohme LLC
Summary
The purpose of this substudy is to assess the efficacy and safety of ifinatamab deruxtecan (I-DXd), given alone or with other treatments in participants with metastatic castration-resistant prostate cancer (mCRPC). The goals of this study are to learn about: * The safety of the study treatment and if people tolerate it. * A safe dose level of I-DXd that can be used with other treatments. * Participant levels of prostate specific antigen (PSA) during treatment.
Official title: MK-2400-01A Substudy: A Phase 1/2, Open-label Umbrella Substudy of MK-2400-U01 Master Protocol to Evaluate the Safety and Efficacy of Ifinatamab Deruxtecan-based Treatment Combinations or Ifinatamab Deruxtecan Alone in Participants With Metastatic Castration-resistant Prostate Cancer (mCRPC) (IDeate-Prostate02)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
360
Start Date
2025-07-03
Completion Date
2031-04-01
Last Updated
2026-04-02
Healthy Volunteers
No
Interventions
Docetaxel
Administered via Intravenous (IV) infusion at a specified dose on specified days
Ifinatamab Deruxtecan
Administered via IV infusion at a specified dose on specified days
MK-5684
Administered orally at a specified dose on specified days
Abiraterone
Administered orally at a specified dose on specified days
Enzalutamide
Administered orally at a specified dose on specified days
Rescue Medication
Before each dose of I-DXd, participants are required to take premedication for prevention of nausea and vomiting with a 2- or 3-drug combination regimen (eg, dexamethasone with either a 5-HT3 receptor antagonist or an NK-1 receptor antagonist as well as other drugs as indicated) per approved product label.
Locations (72)
UCSF Medical Center at Mission Bay ( Site 0034)
San Francisco, California, United States
MedStar Georgetown Cancer Institute at MedStar Washington Hospital Center ( Site 0026)
Washington D.C., District of Columbia, United States
UPMC Hillman Cancer Center ( Site 0014)
Pittsburgh, Pennsylvania, United States
The West Clinic, PLLC dba West Cancer Center ( Site 0005)
Germantown, Tennessee, United States
Fred Hutchinson Cancer Center ( Site 0013)
Seattle, Washington, United States
Instituto Alexander Fleming ( Site 0202)
Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina
Fundación CORI para la Investigación y Prevención del Cáncer ( Site 0200)
La Rioja, Argentina
Macquarie University-MQ Health Clinical Trials Unit ( Site 0801)
Macquarie University, New South Wales, Australia
Liga Norte Riograndense Contra o Câncer ( Site 0271)
Natal, Rio Grande do Norte, Brazil
Irmandade da Santa Casa de Misericórdia de Porto Alegre ( Site 0270)
Porto Alegre, Rio Grande do Sul, Brazil
Hospital Moinhos de Vento ( Site 0278)
Porto Alegre, Rio Grande do Sul, Brazil
Hospital Universitário São Francisco de Assis - Bragança Paulista ( Site 0268)
Bragança Paulista, São Paulo, Brazil
Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo (USP) ( Site 0273)
Ribeirão Preto, São Paulo, Brazil
Fundação Faculdade Regional de Medicina de São José do Rio Preto ( Site 0263)
São José do Rio Preto, São Paulo, Brazil
Hospital Alemao Oswaldo Cruz ( Site 0279)
São Paulo, São Paulo, Brazil
IPITEC ( Site 0275)
São Paulo, Brazil
IBCC - Instituto Brasileiro de Controle do Câncer ( Site 0269)
São Paulo, Brazil
BC Cancer - Vancouver Center ( Site 0103)
Vancouver, British Columbia, Canada
Sunnybrook Research Institute ( Site 0109)
Toronto, Ontario, Canada
Princess Margaret Cancer Centre ( Site 0102)
Toronto, Ontario, Canada
Jewish General Hospital ( Site 0108)
Montreal, Quebec, Canada
Clinica Universidad Catolica del Maule ( Site 0236)
Talca, Maule Region, Chile
FALP ( Site 0232)
Santiago, Region M. de Santiago, Chile
Centro de Oncología de Precisión ( Site 0241)
Santiago, Region M. de Santiago, Chile
Bradfordhill ( Site 0231)
Santiago, Region M. de Santiago, Chile
ONCOCENTRO APYS ( Site 0234)
Viña del Mar, Región de Valparaíso, Chile
Institut Bergonié - Centre Régional de Lutte Contre Le Cancer de Bordeaux et Sud Ouest ( Site 0498)
Bordeaux, Gironde, France
Centre Oscar Lambret ( Site 0495)
Lille, Nord, France
Institut De Cancerologie De L Ouest ( Site 0494)
Saint-Herblain, Pays de la Loire Region, France
Centre Hospitalier de la Côte Basque ( Site 0496)
Bayonne, Pyrenees-Atlantiques, France
centre hospitalier lyon sud ( Site 0497)
Pierre-Bénite, Rhone, France
NCT ( Site 0528)
Heidelberg, Baden-Wurttemberg, Germany
Universitaetsklinikum Jena ( Site 0525)
Jena, Thuringia, Germany
Universitaetsklinikum Hamburg-Eppendorf ( Site 0524)
Hamburg, Germany
St Vincent's University Hospital ( Site 0463)
Dublin, Dublin, Ireland
Beaumont Hospital, Dublin ( Site 0465)
Dublin, Ireland
Rambam Health Care Campus ( Site 0400)
Haifa, Israel
Rabin Medical Center ( Site 0402)
Petah Tikva, Israel
Sheba Medical Center ( Site 0401)
Ramat Gan, Israel
Sourasky Medical Center ( Site 0403)
Tel Aviv, Israel
A.O.U. Federico II di Napoli ( Site 0435)
Naples, Napoli, Italy
AOU San Luigi Gonzaga di Orbassano ( Site 0434)
Orbassano, Torino, Italy
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia ( Site 0432)
Brescia, Italy
Fondazione IRCCS Istituto Nazionale Dei Tumori ( Site 0431)
Milan, Italy
Fondazione Policlinico Universitario Agostino Gemelli ( Site 0433)
Roma, Italy
Ziekenhuis Gelderse Vallei ( Site 0683)
Ede, Gelderland, Netherlands
UMC St. Radboud ( Site 0679)
Nijmegen, Gelderland, Netherlands
Nij Smellinghe ( Site 0684)
Drachten, Provincie Friesland, Netherlands
Auckland City Hospital ( Site 0831)
Auckland, New Zealand
Uniwersytecki Szpital Kliniczny w Poznaniu ( Site 0590)
Poznan, Greater Poland Voivodeship, Poland
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie ( Site 0586)
Warsaw, Masovian Voivodeship, Poland
Uniwersyteckie Centrum Kliniczne ( Site 0588)
Gdansk, Pomeranian Voivodeship, Poland
Szpital Wojewódzki im. M.Kopernika Oddział Onk. Klinicznej z Pododdziałem Chemioterapii Jednodniowej ( Site 0587)
Koszalin, West Pomeranian Voivodeship, Poland
Asan Medical Center ( Site 0925)
Songpagu, Seoul, South Korea
Severance Hospital Yonsei University Health System ( Site 0924)
Seoul, South Korea
Samsung Medical Center ( Site 0926)
Seoul, South Korea
ICO L Hospitalet ( Site 0617)
L Hospitalet Del Llobregat, Barcelona, Spain
Hospital Universitario Ramon y Cajal ( Site 0620)
Madrid, Spain
Hospital Clinico San Carlos ( Site 0618)
Madrid, Spain
Hospital Universitario 12 de Octubre ( Site 0622)
Madrid, Spain
Hospital Universitario Virgen del Rocio ( Site 0619)
Seville, Spain
Taichung Veterans General Hospital ( Site 0902)
Taichung, Taiwan
Taipei Veterans General Hospital ( Site 0901)
Taipei, Taiwan
Baskent University Dr. Turgut Noyan Research and Training Center ( Site 0650)
Adana, Turkey (Türkiye)
Hacettepe Universitesi Tip Fakultesi ( Site 0648)
Ankara, Turkey (Türkiye)
Ankara Bilkent Şehir Hastanesi ( Site 0654)
Ankara, Turkey (Türkiye)
Koç Üniversitesi Hastanesi ( Site 0656)
Istanbul, Turkey (Türkiye)
Istanbul Universitesi Cerrahpasa ( Site 0649)
Istanbul, Turkey (Türkiye)
Addenbrooke's Hospital ( Site 0747)
Cambridge, Cambridgeshire, United Kingdom
St Bartholomew's Hospital ( Site 0749)
London, London, City of, United Kingdom
Royal Free Hospital ( Site 0743)
London, London, City of, United Kingdom
Royal Marsden Hospital (Sutton) ( Site 0741)
London, Surrey, United Kingdom