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Набира участници Фаза 1/2 NCT06863272

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)

Фаза 1/2 – комбинирано ранно изпитване
Заболявания: Castration-Resistant Prostatic Cancer Metastasis

Спонсор: Merck Sharp & Dohme LLC

Налично на: БГ
Обобщение
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.
Описание
This sub study MK-2400-01A assesses treatments for metastatic castration-resistant prostate cancer (mCRPC). The master screening protocol is MK-2400-U01
Кой може да участва
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
Интервенции
Docetaxel
DRUG
Ifinatamab Deruxtecan
DRUG
MK-5684
DRUG
Abiraterone
DRUG
Enzalutamide
DRUG
Rescue Medication
DRUG
Места на провеждане 75
Argentina (2)
Instituto Alexander Fleming ( Site 0202)
Ciudad Autónoma de Buenos Aires , Buenos Aires
Study Coordinator
Fundación CORI para la Investigación y Prevención del Cáncer ( Site 0200)
La Rioja
Study Coordinator
Австралия (1)
Macquarie University-MQ Health Clinical Trials Unit ( Site 0801)
Macquarie University , New South Wales
Study Coordinator
Бразилия (9)
Hospital Universitário São Francisco de Assis - Bragança Paulista ( Site 0268)
Bragança Paulista , São Paulo
Study Coordinator
Liga Norte Riograndense Contra o Câncer ( Site 0271)
Natal , Rio Grande do Norte
Study Coordinator
Irmandade da Santa Casa de Misericórdia de Porto Alegre ( Site 0270)
Porto Alegre , Rio Grande do Sul
Study Coordinator
Hospital Moinhos de Vento ( Site 0278)
Porto Alegre , Rio Grande do Sul
Study Coordinator
Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo (USP) ( Site 0273)
Ribeirão Preto , São Paulo
Study Coordinator
Fundação Faculdade Regional de Medicina de São José do Rio Preto ( Site 0263)
São José do Rio Preto , São Paulo
Study Coordinator
Hospital Alemao Oswaldo Cruz ( Site 0279)
São Paulo , São Paulo
Study Coordinator
IPITEC ( Site 0275)
São Paulo
Study Coordinator
IBCC - Instituto Brasileiro de Controle do Câncer ( Site 0269)
São Paulo
Study Coordinator
Канада (5)
Jewish General Hospital ( Site 0108)
Montreal , Quebec
Study Coordinator
CIUSSS de l Estrie - CHUS - Centre Hosp. Univ. Sherbrooke ( Site 0107)
Sherbrooke , Quebec
Study Coordinator
Sunnybrook Research Institute ( Site 0109)
Toronto , Ontario
Study Coordinator
Princess Margaret Cancer Centre ( Site 0102)
Toronto , Ontario
Study Coordinator
BC Cancer - Vancouver Center ( Site 0103)
Vancouver , British Columbia
Study Coordinator
Chile (5)
FALP ( Site 0232)
Santiago , Region M. de Santiago
Study Coordinator
Centro de Oncología de Precisión ( Site 0241)
Santiago , Region M. de Santiago
Study Coordinator
Bradfordhill ( Site 0231)
Santiago , Region M. de Santiago
Study Coordinator
Clinica Universidad Catolica del Maule ( Site 0236)
Talca , Maule Region
Study Coordinator
ONCOCENTRO APYS ( Site 0234)
Viña del Mar , Valparaiso
Study Coordinator
Франция (5)
Centre Hospitalier de la Côte Basque ( Site 0496)
Bayonne , Pyrenees-Atlantiques
Study Coordinator
Institut Bergonié - Centre Régional de Lutte Contre Le Cancer de Bordeaux et Sud Ouest ( Site 0498)
Bordeaux , Gironde
Study Coordinator
Centre Oscar Lambret ( Site 0495)
Lille , Nord
Study Coordinator
centre hospitalier lyon sud ( Site 0497)
Pierre-Bénite , Rhone
Study Coordinator
Institut De Cancerologie De L Ouest ( Site 0494)
Saint-Herblain , Pays de la Loire Region
Study Coordinator
Германия (3)
Universitaetsklinikum Hamburg-Eppendorf ( Site 0524)
Hamburg
Study Coordinator
NCT ( Site 0528)
Heidelberg , Baden-Wurttemberg
Study Coordinator
Universitaetsklinikum Jena ( Site 0525)
Jena , Thuringia
Study Coordinator
Ireland (2)
St Vincent's University Hospital ( Site 0463)
Dublin , Dublin
Study Coordinator
Beaumont Hospital, Dublin ( Site 0465)
Dublin
Study Coordinator
Израел (4)
Rambam Health Care Campus ( Site 0400)
Haifa
Study Coordinator
Rabin Medical Center ( Site 0402)
Petah Tikva
Study Coordinator
Sheba Medical Center ( Site 0401)
Ramat Gan
Study Coordinator
Sourasky Medical Center ( Site 0403)
Tel Aviv
Study Coordinator
Италия (5)
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia ( Site 0432)
Brescia
Study Coordinator
Fondazione IRCCS Istituto Nazionale Dei Tumori ( Site 0431)
Milan
Study Coordinator
A.O.U. Federico II di Napoli ( Site 0435)
Naples , Napoli
Study Coordinator
AOU San Luigi Gonzaga di Orbassano ( Site 0434)
Orbassano , Torino
Study Coordinator
Fondazione Policlinico Universitario Agostino Gemelli ( Site 0433)
Roma
Study Coordinator
Нидерландия (3)
Nij Smellinghe ( Site 0684)
Drachten , Provincie Friesland
Study Coordinator
Ziekenhuis Gelderse Vallei ( Site 0683)
Ede , Gelderland
Study Coordinator
UMC St. Radboud ( Site 0679)
Nijmegen , Gelderland
Study Coordinator
New Zealand (1)
Auckland City Hospital ( Site 0831)
Auckland
Study Coordinator
Полша (4)
Uniwersyteckie Centrum Kliniczne ( Site 0588)
Gdansk , Pomeranian Voivodeship
Study Coordinator
Szpital Wojewódzki im. M.Kopernika Oddział Onk. Klinicznej z Pododdziałem Chemioterapii Jednodniowej ( Site 0587)
Koszalin , West Pomeranian Voivodeship
Study Coordinator
Uniwersytecki Szpital Kliniczny w Poznaniu ( Site 0590)
Poznan , Greater Poland Voivodeship
Study Coordinator
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie ( Site 0586)
Warsaw , Masovian Voivodeship
Study Coordinator
Южна Корея (3)
Severance Hospital Yonsei University Health System ( Site 0924)
Seoul
ACTIVE_NOT_RECRUITING
Samsung Medical Center ( Site 0926)
Seoul
Study Coordinator
Asan Medical Center ( Site 0925)
Songpagu , Seoul
Study Coordinator
Испания (5)
ICO L Hospitalet ( Site 0617)
L Hospitalet Del Llobregat , Barcelona
Study Coordinator
Hospital Universitario Ramon y Cajal ( Site 0620)
Madrid
Study Coordinator
Hospital Clinico San Carlos ( Site 0618)
Madrid
Study Coordinator
Hospital Universitario 12 de Octubre ( Site 0622)
Madrid
Study Coordinator
Hospital Universitario Virgen del Rocio ( Site 0619)
Seville
Study Coordinator
Taiwan (2)
Taichung Veterans General Hospital ( Site 0902)
Taichung
Study Coordinator
Taipei Veterans General Hospital ( Site 0901)
Taipei
Study Coordinator
Турция (6)
Baskent University Dr. Turgut Noyan Research and Training Center ( Site 0650)
Adana
Study Coordinator
Hacettepe Universitesi Tip Fakultesi ( Site 0648)
Ankara
Study Coordinator
Ankara Universitesi Tip Fakultesi Hastanesi ( Site 0653)
Ankara
Study Coordinator
Ankara Bilkent Şehir Hastanesi ( Site 0654)
Ankara
Study Coordinator
Koç Üniversitesi Hastanesi ( Site 0656)
Istanbul
Study Coordinator
Istanbul Universitesi Cerrahpasa ( Site 0649)
Istanbul
Study Coordinator
Великобритания (4)
Addenbrooke's Hospital ( Site 0747)
Cambridge , Cambridgeshire
Study Coordinator
St Bartholomew's Hospital ( Site 0749)
London , London, City of
Study Coordinator
Royal Free Hospital ( Site 0743)
London , London, City of
Study Coordinator
Royal Marsden Hospital (Sutton) ( Site 0741)
London , Surrey
Study Coordinator
САЩ (6)
The West Clinic, PLLC dba West Cancer Center ( Site 0005)
Germantown , Tennessee
Study Coordinator
Memorial Sloan Kettering Cancer Center ( Site 0006)
New York , New York
Study Coordinator
UPMC Hillman Cancer Center ( Site 0014)
Pittsburgh , Pennsylvania
Study Coordinator
UCSF Medical Center at Mission Bay ( Site 0034)
San Francisco , California
Study Coordinator
Fred Hutchinson Cancer Center ( Site 0013)
Seattle , Washington
Study Coordinator
MedStar Georgetown Cancer Institute at MedStar Washington Hospital Center ( Site 0026)
Washington D.C. , District of Columbia
Study Coordinator
Технически детайли
Статус
Набира участници
Фаза
Фаза 1/2
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
18 Years
Здрави доброволци
Не
Начална дата
03.07.2025
Крайна дата
01.04.2031
Регистрационен номер
NCT06863272
Източник
clinicaltrials.gov
Запитване за медицински туризъм

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