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RECRUITING Phase 1 / Phase 2 ClinicalTrials.gov

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 • ClinicalTrials.gov ID: NCT06863272

Registry updated: 2026-10-09
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Description

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.

Interventions

  • Docetaxel (Drug)
    Administered via Intravenous (IV) infusion at a specified dose on specified days
  • Ifinatamab Deruxtecan (Drug)
    Administered via IV infusion at a specified dose on specified days
  • Opevesostat (Drug)
    Administered orally at a specified dose on specified days
  • Abiraterone (Drug)
    Administered orally at a specified dose on specified days
  • Enzalutamide (Drug)
    Administered orally at a specified dose on specified days
  • Rescue Medication (Drug)
    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.

Eligibility criteria

Inclusion Criteria: The main inclusion criteria include but are not limited to the following: * Has histologically- or cytologically-confirmed adenocarcinoma of the prostate without small cell histology * Has prostate cancer progression while on androgen deprivation therapy (ADT) (or post bilateral orchiectomy) within 6 months before Screening * Has current evidence of distant metastatic disease * Has received prior treatment with 1 or 2 androgen receptor pathway inhibitors (ARPIs) and progressed during or after treatment * Participants receiving bone resorptive therapy (including, but not limited to bisphosphonate or denosumab) must have been on stable doses for ≥4 weeks before allocation/randomization * An Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 assessed within 10 days before allocation/randomization * Has prior treatment with poly-ADP-ribose polymerase inhibitors (PARPi) if indicated by local approved regimen or were deemed ineligible to receive PARPi by the investigator Exclusion Criteria: The main exclusion criteria include but are not limited to the following: * Has any history of interstitial lung disease (ILD)/pneumonitis irrespective of steroid use (except for a history of radiation pneumonitis that did not require steroids), current ILD, clinical or radiographic suspicion of ILD for which the diagnosis of ILD cannot be ruled out * Clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses * Uncontrolled or significant cardiovascular disease * History of pituitary dysfunction * Poorly controlled diabetes mellitus * History or current condition of adrenal insufficiency (eg, Addison's disease) * Has received prior treatment with taxane-based chemotherapy agent for metastatic castration-resistant prostate cancer (mCRPC). * Chronic steroid treatment (dose of \>10 mg daily prednisone equivalent), except for low-dose inhaled steroids (for asthma/chronic obstructive pulmonary disease), topical steroids (for mild skin conditions), or intra-articular steroid injections * Received prior radiotherapy within 2 weeks of start of study intervention, or has radiation-related toxicities, requiring corticosteroids * Known additional malignancy that is progressing or has required active treatment within the past 3 years * Known active central nervous system (CNS) metastases and/or carcinomatous meningitis * Active autoimmune disease that has required systemic treatment in the past 2 years * History of allogeneic tissue/solid organ transplant

Conditions

Castration-Resistant Prostatic Cancer Metastasis

Locations

  • UCLA Hematology & Oncology ( Site 0003) — Los Angeles, California, United States
  • University of California-Irvine Medical Center ( Site 0016) — Orange, California, United States
  • 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
  • University of Michigan ( Site 0021) — Ann Arbor, Michigan, 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
  • Fundación Arturo López Pérez ( 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 Cote 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 Ulm. ( Site 0530) — Ulm, 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
  • Tallaght University Hospital ( Site 0462) — Dublin, Ireland
  • Rambam Health Care Campus ( Site 0400) — Haifa, Israel
  • Hadassah Medical Center ( Site 0404) — Jerusalem, 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
  • 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
  • A.O.U. Federico II di Napoli ( Site 0435) — Naples, 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)
  • Recep Tayyip Erdogan University Training and Research Hospital ( Site 0655) — Rize, 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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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record