RecruitingPhase 1Phase 2NCT06863272

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)

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)

Sponsor

Merck Sharp & Dohme LLC

Enrollment

360 participants

Start Date

Jul 3, 2025

Study Type

INTERVENTIONAL

Conditions

Metastasis Castration-Resistant Prostatic Cancer

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a drug called ifinatamab deruxtecan (IFD) — alone or in combination with other cancer treatments — in men with metastatic castration-resistant prostate cancer (mCRPC), meaning prostate cancer that has spread and is no longer responding to hormone-blocking therapy. **You may be eligible if...** - You have confirmed prostate adenocarcinoma (non-small cell type) that has spread to other parts of the body - Your cancer has continued to grow despite androgen deprivation therapy (hormone treatment) - You have been previously treated with 1 or 2 androgen receptor pathway inhibitors (ARPIs) and your cancer has progressed - Any bone-strengthening medications are at a stable dose for at least 4 weeks **You may NOT be eligible if...** - Your prostate cancer is small cell type - You have not received prior ARPI therapy - Your cancer is not metastatic - You have certain serious medical conditions that make these drugs unsafe 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

DRUGDocetaxel

Administered via Intravenous (IV) infusion at a specified dose on specified days

DRUGIfinatamab Deruxtecan

Administered via IV infusion at a specified dose on specified days

DRUGMK-5684

Administered orally at a specified dose on specified days

DRUGAbiraterone

Administered orally at a specified dose on specified days

DRUGEnzalutamide

Administered orally at a specified dose on specified days

DRUGRescue 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(75)

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

Memorial Sloan Kettering Cancer Center ( Site 0006)

New York, New York, 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

CIUSSS de l Estrie - CHUS - Centre Hosp. Univ. Sherbrooke ( Site 0107)

Sherbrooke, 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, Valparaiso, 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 Universitesi Tip Fakultesi Hastanesi ( Site 0653)

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

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NCT06863272

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