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)
Status: Recruiting
Location: See all (74) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
⁃ 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
Locations
United States
California
UCSF Medical Center at Mission Bay ( Site 0034)
RECRUITING
San Francisco
Washington, D.c.
MedStar Georgetown Cancer Institute at MedStar Washington Hospital Center ( Site 0026)
RECRUITING
Washington D.c.
Pennsylvania
UPMC Hillman Cancer Center ( Site 0014)
RECRUITING
Pittsburgh
Tennessee
The West Clinic, PLLC dba West Cancer Center ( Site 0005)
RECRUITING
Germantown
Washington
Fred Hutchinson Cancer Center ( Site 0013)
RECRUITING
Seattle
Other Locations
Argentina
Instituto Alexander Fleming ( Site 0202)
RECRUITING
Ciudad Autónoma De Buenos Aires
Fundación CORI para la Investigación y Prevención del Cáncer ( Site 0200)
RECRUITING
La Rioja
Australia
Macquarie University-MQ Health Clinical Trials Unit ( Site 0801)
RECRUITING
Macquarie University
Brazil
Hospital Universitário São Francisco de Assis - Bragança Paulista ( Site 0268)
RECRUITING
Bragança Paulista
Liga Norte Riograndense Contra o Câncer ( Site 0271)
RECRUITING
Natal
Hospital Moinhos de Vento ( Site 0278)
RECRUITING
Porto Alegre
Irmandade da Santa Casa de Misericórdia de Porto Alegre ( Site 0270)
RECRUITING
Porto Alegre
Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo (USP) ( Site 0273)
RECRUITING
Ribeirão Preto
Fundação Faculdade Regional de Medicina de São José do Rio Preto ( Site 0263)
RECRUITING
São José Do Rio Preto
Hospital Alemao Oswaldo Cruz ( Site 0279)
RECRUITING
São Paulo
IBCC - Instituto Brasileiro de Controle do Câncer ( Site 0269)
RECRUITING
São Paulo
IPITEC ( Site 0275)
RECRUITING
São Paulo
Canada
Jewish General Hospital ( Site 0108)
RECRUITING
Montreal
CIUSSS de l Estrie - CHUS - Centre Hosp. Univ. Sherbrooke ( Site 0107)
RECRUITING
Sherbrooke
Princess Margaret Cancer Centre ( Site 0102)
RECRUITING
Toronto
Sunnybrook Research Institute ( Site 0109)
RECRUITING
Toronto
BC Cancer - Vancouver Center ( Site 0103)
RECRUITING
Vancouver
Chile
Bradfordhill ( Site 0231)
RECRUITING
Santiago
Centro de Oncología de Precisión ( Site 0241)
RECRUITING
Santiago
FALP ( Site 0232)
RECRUITING
Santiago
Clinica Universidad Catolica del Maule ( Site 0236)
RECRUITING
Talca
ONCOCENTRO APYS ( Site 0234)
RECRUITING
Viña Del Mar
France
Centre Hospitalier de la Côte Basque ( Site 0496)
RECRUITING
Bayonne
Institut Bergonié - Centre Régional de Lutte Contre Le Cancer de Bordeaux et Sud Ouest ( Site 0498)
RECRUITING
Bordeaux
Centre Oscar Lambret ( Site 0495)
RECRUITING
Lille
centre hospitalier lyon sud ( Site 0497)
RECRUITING
Pierre-bénite
Institut De Cancerologie De L Ouest ( Site 0494)
RECRUITING
Saint-herblain
Germany
Universitaetsklinikum Hamburg-Eppendorf ( Site 0524)
RECRUITING
Hamburg
NCT ( Site 0528)
RECRUITING
Heidelberg
Universitaetsklinikum Jena ( Site 0525)
RECRUITING
Jena
Ireland
Beaumont Hospital, Dublin ( Site 0465)
RECRUITING
Dublin
St Vincent's University Hospital ( Site 0463)
RECRUITING
Dublin
Israel
Rambam Health Care Campus ( Site 0400)
RECRUITING
Haifa
Rabin Medical Center ( Site 0402)
RECRUITING
Petah Tikva
Sheba Medical Center ( Site 0401)
RECRUITING
Ramat Gan
Sourasky Medical Center ( Site 0403)
RECRUITING
Tel Aviv
Italy
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia ( Site 0432)
RECRUITING
Brescia
Fondazione IRCCS Istituto Nazionale Dei Tumori ( Site 0431)
RECRUITING
Milan
A.O.U. Federico II di Napoli ( Site 0435)
RECRUITING
Naples
AOU San Luigi Gonzaga di Orbassano ( Site 0434)
RECRUITING
Orbassano
Fondazione Policlinico Universitario Agostino Gemelli ( Site 0433)
RECRUITING
Roma
Netherlands
Nij Smellinghe ( Site 0684)
RECRUITING
Drachten
Ziekenhuis Gelderse Vallei ( Site 0683)
RECRUITING
Ede
UMC St. Radboud ( Site 0679)
RECRUITING
Nijmegen
New Zealand
Auckland City Hospital ( Site 0831)
RECRUITING
Auckland
Poland
Uniwersyteckie Centrum Kliniczne ( Site 0588)
RECRUITING
Gdansk
Szpital Wojewódzki im. M.Kopernika Oddział Onk. Klinicznej z Pododdziałem Chemioterapii Jednodniowej ( Site 0587)
RECRUITING
Koszalin
Uniwersytecki Szpital Kliniczny w Poznaniu ( Site 0590)
RECRUITING
Poznan
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie ( Site 0586)
RECRUITING
Warsaw
Republic of Korea
Samsung Medical Center ( Site 0926)
RECRUITING
Seoul
Severance Hospital Yonsei University Health System ( Site 0924)
ACTIVE_NOT_RECRUITING
Seoul
Asan Medical Center ( Site 0925)
RECRUITING
Songpagu
Spain
ICO L Hospitalet ( Site 0617)
RECRUITING
L Hospitalet Del Llobregat
Hospital Clinico San Carlos ( Site 0618)
RECRUITING
Madrid
Hospital Universitario 12 de Octubre ( Site 0622)
RECRUITING
Madrid
Hospital Universitario Ramon y Cajal ( Site 0620)
RECRUITING
Madrid
Hospital Universitario Virgen del Rocio ( Site 0619)
RECRUITING
Seville
Taiwan
Taichung Veterans General Hospital ( Site 0902)
RECRUITING
Taichung
Taipei Veterans General Hospital ( Site 0901)
RECRUITING
Taipei
Turkey
Baskent University Dr. Turgut Noyan Research and Training Center ( Site 0650)
RECRUITING
Adana
Ankara Bilkent Şehir Hastanesi ( Site 0654)
RECRUITING
Ankara
Ankara Universitesi Tip Fakultesi Hastanesi ( Site 0653)
RECRUITING
Ankara
Hacettepe Universitesi Tip Fakultesi ( Site 0648)
RECRUITING
Ankara
Istanbul Universitesi Cerrahpasa ( Site 0649)
RECRUITING
Istanbul
Koç Üniversitesi Hastanesi ( Site 0656)
RECRUITING
Istanbul
United Kingdom
Addenbrooke's Hospital ( Site 0747)
RECRUITING
Cambridge
Royal Free Hospital ( Site 0743)
RECRUITING
London
Royal Marsden Hospital (Sutton) ( Site 0741)
RECRUITING
London
St Bartholomew's Hospital ( Site 0749)
RECRUITING
London
Contact Information
Primary
Toll Free Number
Trialsites@msd.com
1-888-577-8839
Time Frame
Start Date: 2025-07-03
Estimated Completion Date: 2031-04-01
Participants
Target number of participants: 360
Treatments
Active_comparator: Docetaxel
Participants will receive docetaxel at a determined dose every 3 weeks (Q3W) for a maximum of 10 cycles. Each cycle is 21 days.
Experimental: Ifinatamab Deruxtecan (I-DXd)
Participants will receive I-DXd at a determined dose Q3W until unacceptable toxicity, progressive disease (PD), death or withdrawal of consent.
Experimental: I-DXd + MK-5684
Following a dose escalation regimen with I-DXd, participants will receive I-DXd at a determined dose until unacceptable toxicity, PD, death or withdrawal of consent PLUS MK-5684 at a determined dose until any of the criterion for discontinuation of study intervention is met.
Experimental: I-DXd +ARPI (Abiraterone or Enzalutamide)
Following a dose escalation regimen with I-DXd, participants will receive I-DXd at a determined dose until unacceptable toxicity, PD, death or withdrawal of consent PLUS ARPI (Androgen Receptor Pathway Inhibitor) - Abiraterone acetate OR Enzalutamide at a determined dose until any of the criterion for discontinuation of study intervention is met.
Related Therapeutic Areas
Sponsors
Collaborators: Daiichi Sankyo
Leads: Merck Sharp & Dohme LLC