TrialPath
Recruiting

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)

NCT06863272 · Merck Sharp & Dohme LLC
In plain English

Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.

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)
About this study
This sub study MK-2400-01A assesses treatments for metastatic castration-resistant prostate cancer (mCRPC). The master screening protocol is MK-2400-U01
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 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: * History of (non-infectious) interstitial lung disease (ILD)/pneumonitis that required steroids, or has current ILD/pneumonitis or suspected ILD/pneumonitis * 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
Study design
Enrollment target: 360 participants
Allocation: randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2025-07-03
Estimated completion: 2031-04-01
Last updated: 2026-05-29
Interventions
Drug: DocetaxelDrug: Ifinatamab DeruxtecanDrug: MK-5684Drug: AbirateroneDrug: EnzalutamideDrug: Rescue Medication
Primary outcomes
  • Efficacy Phase: Number of Participants Who Experience One or More Dose-Limiting Toxicities (DLTs) - Combination Arms Only (Up to approximately 21 days)
  • Efficacy Phase: Number of Participants Who Experienced an Adverse Event (AE) (Up to approximately 54 months)
  • Efficacy Phase: Number of Participants Who Discontinued Study Intervention Due to an AE (Up to approximately 24 months)
Sponsor
Merck Sharp & Dohme LLC · industry
With: Daiichi Sankyo
Contacts & investigators
ContactToll Free Number · contact · Trialsites@msd.com · 1-888-577-8839
InvestigatorMedical Director · study_director, Merck Sharp & Dohme LLC
All locations (80)
UCLA Hematology & Oncology ( Site 0003)Recruiting
Los Angeles, California, United States
University of California-Irvine Medical Center ( Site 0016)Recruiting
Orange, California, United States
UCSF Medical Center at Mission Bay ( Site 0034)Recruiting
San Francisco, California, United States
MedStar Georgetown Cancer Institute at MedStar Washington Hospital Center ( Site 0026)Recruiting
Washington D.C., District of Columbia, United States
Memorial Sloan Kettering Cancer Center ( Site 0006)Recruiting
New York, New York, United States
UPMC Hillman Cancer Center ( Site 0014)Recruiting
Pittsburgh, Pennsylvania, United States
The West Clinic, PLLC dba West Cancer Center ( Site 0005)Recruiting
Germantown, Tennessee, United States
Fred Hutchinson Cancer Center ( Site 0013)Recruiting
Seattle, Washington, United States
Instituto Alexander Fleming ( Site 0202)Recruiting
Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina
Fundación CORI para la Investigación y Prevención del Cáncer ( Site 0200)Recruiting
La Rioja, Argentina
Macquarie University-MQ Health Clinical Trials Unit ( Site 0801)Recruiting
Macquarie University, New South Wales, Australia
Liga Norte Riograndense Contra o Câncer ( Site 0271)Recruiting
Natal, Rio Grande do Norte, Brazil
Irmandade da Santa Casa de Misericórdia de Porto Alegre ( Site 0270)Recruiting
Porto Alegre, Rio Grande do Sul, Brazil
Hospital Moinhos de Vento ( Site 0278)Recruiting
Porto Alegre, Rio Grande do Sul, Brazil
Hospital Universitário São Francisco de Assis - Bragança Paulista ( Site 0268)Recruiting
Bragança Paulista, São Paulo, Brazil
Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo (USP) ( Site 0273)Recruiting
Ribeirão Preto, São Paulo, Brazil
Fundação Faculdade Regional de Medicina de São José do Rio Preto ( Site 0263)Recruiting
São José do Rio Preto, São Paulo, Brazil
Hospital Alemao Oswaldo Cruz ( Site 0279)Recruiting
São Paulo, São Paulo, Brazil
IPITEC ( Site 0275)Recruiting
São Paulo, Brazil
IBCC - Instituto Brasileiro de Controle do Câncer ( Site 0269)Recruiting
São Paulo, Brazil
BC Cancer - Vancouver Center ( Site 0103)Recruiting
Vancouver, British Columbia, Canada
Sunnybrook Research Institute ( Site 0109)Recruiting
Toronto, Ontario, Canada
Princess Margaret Cancer Centre ( Site 0102)Recruiting
Toronto, Ontario, Canada
Jewish General Hospital ( Site 0108)Recruiting
Montreal, Quebec, Canada
CIUSSS de l Estrie - CHUS - Centre Hosp. Univ. Sherbrooke ( Site 0107)Recruiting
Sherbrooke, Quebec, Canada
Clinica Universidad Catolica del Maule ( Site 0236)Recruiting
Talca, Maule Region, Chile
FALP ( Site 0232)Recruiting
Santiago, Region M. de Santiago, Chile
Centro de Oncología de Precisión ( Site 0241)Recruiting
Santiago, Region M. de Santiago, Chile
Bradfordhill ( Site 0231)Recruiting
Santiago, Region M. de Santiago, Chile
ONCOCENTRO APYS ( Site 0234)Recruiting
Viña del Mar, Valparaiso, Chile
Institut Bergonié - Centre Régional de Lutte Contre Le Cancer de Bordeaux et Sud Ouest ( Site 0498)Recruiting
Bordeaux, Gironde, France
Centre Oscar Lambret ( Site 0495)Recruiting
Lille, Nord, France
Institut De Cancerologie De L Ouest ( Site 0494)Recruiting
Saint-Herblain, Pays de la Loire Region, France
Centre Hospitalier de la Côte Basque ( Site 0496)Recruiting
Bayonne, Pyrenees-Atlantiques, France
centre hospitalier lyon sud ( Site 0497)Recruiting
Pierre-Bénite, Rhone, France
NCT ( Site 0528)Recruiting
Heidelberg, Baden-Wurttemberg, Germany
Universitaetsklinikum Jena ( Site 0525)Recruiting
Jena, Thuringia, Germany
Universitaetsklinikum Hamburg-Eppendorf ( Site 0524)Recruiting
Hamburg, Germany
St Vincent's University Hospital ( Site 0463)Recruiting
Dublin, Dublin, Ireland
Beaumont Hospital, Dublin ( Site 0465)Recruiting
Dublin, Ireland
Tallaght University Hospital ( Site 0462)Recruiting
Dublin, Ireland
Rambam Health Care Campus ( Site 0400)Recruiting
Haifa, Israel
Hadassah Medical Center ( Site 0404)Recruiting
Jerusalem, Israel
Rabin Medical Center ( Site 0402)Recruiting
Petah Tikva, Israel
Sheba Medical Center ( Site 0401)Recruiting
Ramat Gan, Israel
Sourasky Medical Center ( Site 0403)Recruiting
Tel Aviv, Israel
AOU San Luigi Gonzaga di Orbassano ( Site 0434)Recruiting
Orbassano, Torino, Italy
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia ( Site 0432)Recruiting
Brescia, Italy
Fondazione IRCCS Istituto Nazionale Dei Tumori ( Site 0431)Recruiting
Milan, Italy
A.O.U. Federico II di Napoli ( Site 0435)Recruiting
Naples, Italy
Fondazione Policlinico Universitario Agostino Gemelli ( Site 0433)Recruiting
Roma, Italy
Ziekenhuis Gelderse Vallei ( Site 0683)Recruiting
Ede, Gelderland, Netherlands
UMC St. Radboud ( Site 0679)Recruiting
Nijmegen, Gelderland, Netherlands
Nij Smellinghe ( Site 0684)Recruiting
Drachten, Provincie Friesland, Netherlands
Auckland City Hospital ( Site 0831)Recruiting
Auckland, New Zealand
Uniwersytecki Szpital Kliniczny w Poznaniu ( Site 0590)Recruiting
Poznan, Greater Poland Voivodeship, Poland
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie ( Site 0586)Recruiting
Warsaw, Masovian Voivodeship, Poland
Uniwersyteckie Centrum Kliniczne ( Site 0588)Recruiting
Gdansk, Pomeranian Voivodeship, Poland
Szpital Wojewódzki im. M.Kopernika Oddział Onk. Klinicznej z Pododdziałem Chemioterapii Jednodniowej ( Site 0587)Recruiting
Koszalin, West Pomeranian Voivodeship, Poland
Asan Medical Center ( Site 0925)Recruiting
Songpagu, Seoul, South Korea
Severance Hospital Yonsei University Health System ( Site 0924)Active Not Recruiting
Seoul, South Korea
Samsung Medical Center ( Site 0926)Recruiting
Seoul, South Korea
ICO L Hospitalet ( Site 0617)Recruiting
L Hospitalet Del Llobregat, Barcelona, Spain
Hospital Universitario Ramon y Cajal ( Site 0620)Recruiting
Madrid, Spain
Hospital Clinico San Carlos ( Site 0618)Recruiting
Madrid, Spain
Hospital Universitario 12 de Octubre ( Site 0622)Recruiting
Madrid, Spain
Hospital Universitario Virgen del Rocio ( Site 0619)Recruiting
Seville, Spain
Taichung Veterans General Hospital ( Site 0902)Recruiting
Taichung, Taiwan
Taipei Veterans General Hospital ( Site 0901)Recruiting
Taipei, Taiwan
Baskent University Dr. Turgut Noyan Research and Training Center ( Site 0650)Recruiting
Adana, Turkey (Türkiye)
Hacettepe Universitesi Tip Fakultesi ( Site 0648)Recruiting
Ankara, Turkey (Türkiye)
Ankara Universitesi Tip Fakultesi Hastanesi ( Site 0653)Recruiting
Ankara, Turkey (Türkiye)
Ankara Bilkent Şehir Hastanesi ( Site 0654)Recruiting
Ankara, Turkey (Türkiye)
Koç Üniversitesi Hastanesi ( Site 0656)Recruiting
Istanbul, Turkey (Türkiye)
Istanbul Universitesi Cerrahpasa ( Site 0649)Recruiting
Istanbul, Turkey (Türkiye)
Recep Tayyip Erdogan University Training and Research Hospital ( Site 0655)Recruiting
Rize, Turkey (Türkiye)
Addenbrooke's Hospital ( Site 0747)Recruiting
Cambridge, Cambridgeshire, United Kingdom
St Bartholomew's Hospital ( Site 0749)Recruiting
London, London, City of, United Kingdom
Royal Free Hospital ( Site 0743)Recruiting
London, London, City of, United Kingdom
Royal Marsden Hospital (Sutton) ( Site 0741)Recruiting
London, Surrey, United Kingdom
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) · TrialPath