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NCT06863272PHASE1, PHASE2Recruiting

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)

Merck Sharp & Dohme LLC

Start Date

7/3/2025

Completion Date

4/1/2031

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.

Detailed Description

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

Age Range: 18 years to No maximum

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

Interventions

DRUG

Docetaxel

DRUG

Ifinatamab Deruxtecan

DRUG

Opevesostat

DRUG

Abiraterone

DRUG

Enzalutamide

DRUG

Rescue Medication

Interested in This Trial?

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Conditions

Castration-Resistant Prostatic CancerMetastasis

Locations

UCLA Hematology & Oncology ( Site 0003)

Los Angeles, California 90095

United States

University of California-Irvine Medical Center ( Site 0016)

Orange, California 92868

United States

UCSF Medical Center at Mission Bay ( Site 0034)

San Francisco, California 94158

United States

MedStar Georgetown Cancer Institute at MedStar Washington Hospital Center ( Site 0026)

Washington D.C., District of Columbia 20010

United States

University of Michigan ( Site 0021)

Ann Arbor, Michigan 48109

United States

Memorial Sloan Kettering Cancer Center ( Site 0006)

New York, New York 10065

United States

UPMC Hillman Cancer Center ( Site 0014)

Pittsburgh, Pennsylvania 15232

United States

The West Clinic, PLLC dba West Cancer Center ( Site 0005)

Germantown, Tennessee 38138

United States

Fred Hutchinson Cancer Center ( Site 0013)

Seattle, Washington 98109

United States

Instituto Alexander Fleming ( Site 0202)

Ciudad Autónoma de Buenos Aires, Buenos Aires C1426ANZ

Argentina

Fundación CORI para la Investigación y Prevención del Cáncer ( Site 0200)

La Rioja, F5300COE

Argentina

Macquarie University-MQ Health Clinical Trials Unit ( Site 0801)

Macquarie University, New South Wales 2109

Australia

Liga Norte Riograndense Contra o Câncer ( Site 0271)

Natal, Rio Grande do Norte 59062-000

Brazil

Irmandade da Santa Casa de Misericórdia de Porto Alegre ( Site 0270)

Porto Alegre, Rio Grande do Sul 90020-090

Brazil

Hospital Moinhos de Vento ( Site 0278)

Porto Alegre, Rio Grande do Sul 90035-001

Brazil

Hospital Universitário São Francisco de Assis - Bragança Paulista ( Site 0268)

Bragança Paulista, São Paulo 12916-542

Brazil

Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo (USP) ( Site 0273)

Ribeirão Preto, São Paulo 14048900

Brazil

Fundação Faculdade Regional de Medicina de São José do Rio Preto ( Site 0263)

São José do Rio Preto, São Paulo 15090-000

Brazil

Hospital Alemao Oswaldo Cruz ( Site 0279)

São Paulo, São Paulo 01327-001

Brazil

IPITEC ( Site 0275)

São Paulo, 01221-020

Brazil

IBCC - Instituto Brasileiro de Controle do Câncer ( Site 0269)

São Paulo, 03102-006

Brazil

BC Cancer - Vancouver Center ( Site 0103)

Vancouver, British Columbia V5Z 4E6

Canada

Sunnybrook Research Institute ( Site 0109)

Toronto, Ontario M4N 3M5

Canada

Princess Margaret Cancer Centre ( Site 0102)

Toronto, Ontario M5G 2M9

Canada

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

Sherbrooke, Quebec J1H 5N4

Canada

Clinica Universidad Catolica del Maule ( Site 0236)

Talca, Maule Region 3465584

Chile

FALP ( Site 0232)

Santiago, Region M. de Santiago 7500921

Chile

Centro de Oncología de Precisión ( Site 0241)

Santiago, Region M. de Santiago 7560908

Chile

Bradfordhill ( Site 0231)

Santiago, Region M. de Santiago 8420383

Chile

ONCOCENTRO APYS ( Site 0234)

Viña del Mar, Valparaiso 2520598

Chile

Institut Bergonié - Centre Régional de Lutte Contre Le Cancer de Bordeaux et Sud Ouest ( Site 0498)

Bordeaux, Gironde 33000

France

Centre Oscar Lambret ( Site 0495)

Lille, Nord 59000

France

Institut De Cancerologie De L Ouest ( Site 0494)

Saint-Herblain, Pays de la Loire Region 44800

France

Centre Hospitalier de la Cote Basque ( Site 0496)

Bayonne, Pyrenees-Atlantiques 64100

France

centre hospitalier lyon sud ( Site 0497)

Pierre-Bénite, Rhone 69310

France

NCT ( Site 0528)

Heidelberg, Baden-Wurttemberg 69120

Germany

Universitaetsklinikum Ulm. ( Site 0530)

Ulm, Baden-Wurttemberg 89081

Germany

Universitaetsklinikum Jena ( Site 0525)

Jena, Thuringia 07747

Germany

Universitaetsklinikum Hamburg-Eppendorf ( Site 0524)

Hamburg, 20246

Germany

St Vincent's University Hospital ( Site 0463)

Dublin, Dublin D04 T6F4

Ireland

Beaumont Hospital, Dublin ( Site 0465)

Dublin, D09 V2N0

Ireland

Tallaght University Hospital ( Site 0462)

Dublin, D24 NR0A

Ireland

Rambam Health Care Campus ( Site 0400)

Haifa, 3109601

Israel

Hadassah Medical Center ( Site 0404)

Jerusalem, 9112001

Israel

Rabin Medical Center ( Site 0402)

Petah Tikva, 4941492

Israel

Sheba Medical Center ( Site 0401)

Ramat Gan, 5265601

Israel

Sourasky Medical Center ( Site 0403)

Tel Aviv, 6423906

Israel

AOU San Luigi Gonzaga di Orbassano ( Site 0434)

Orbassano, Torino 10143

Italy

Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia ( Site 0432)

Brescia, 25123

Italy

Fondazione IRCCS Istituto Nazionale Dei Tumori ( Site 0431)

Milan, 20133

Italy

A.O.U. Federico II di Napoli ( Site 0435)

Naples, 80131

Italy

Fondazione Policlinico Universitario Agostino Gemelli ( Site 0433)

Roma, 00168

Italy

Ziekenhuis Gelderse Vallei ( Site 0683)

Ede, Gelderland 6716 RP

Netherlands

UMC St. Radboud ( Site 0679)

Nijmegen, Gelderland 6525 GA

Netherlands

Nij Smellinghe ( Site 0684)

Drachten, Provincie Friesland 9202 NN

Netherlands

Auckland City Hospital ( Site 0831)

Auckland, 1023

New Zealand

Uniwersytecki Szpital Kliniczny w Poznaniu ( Site 0590)

Poznan, Greater Poland Voivodeship 60-355

Poland

Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie ( Site 0586)

Warsaw, Masovian Voivodeship 02-781

Poland

Uniwersyteckie Centrum Kliniczne ( Site 0588)

Gdansk, Pomeranian Voivodeship 80-214

Poland

Szpital Wojewódzki im. M.Kopernika Oddział Onk. Klinicznej z Pododdziałem Chemioterapii Jednodniowej ( Site 0587)

Koszalin, West Pomeranian Voivodeship 75-581

Poland

Asan Medical Center ( Site 0925)

Songpagu, Seoul 05505

South Korea

Severance Hospital Yonsei University Health System ( Site 0924)

Seoul, 03722

South Korea

Samsung Medical Center ( Site 0926)

Seoul, 06351

South Korea

ICO L Hospitalet ( Site 0617)

L Hospitalet Del Llobregat, Barcelona 08908

Spain

Hospital Universitario Ramon y Cajal ( Site 0620)

Madrid, 28034

Spain

Hospital Clinico San Carlos ( Site 0618)

Madrid, 28040

Spain

Hospital Universitario 12 de Octubre ( Site 0622)

Madrid, 28041

Spain

Hospital Universitario Virgen del Rocio ( Site 0619)

Seville, 41013

Spain

Taichung Veterans General Hospital ( Site 0902)

Taichung, 40705

Taiwan

Taipei Veterans General Hospital ( Site 0901)

Taipei, 11217

Taiwan

Baskent University Dr. Turgut Noyan Research and Training Center ( Site 0650)

Adana, 01250

Turkey (Türkiye)

Hacettepe Universitesi Tip Fakultesi ( Site 0648)

Ankara, 06230

Turkey (Türkiye)

Ankara Universitesi Tip Fakultesi Hastanesi ( Site 0653)

Ankara, 06620

Turkey (Türkiye)

Ankara Bilkent Şehir Hastanesi ( Site 0654)

Ankara, 06800

Turkey (Türkiye)

Koç Üniversitesi Hastanesi ( Site 0656)

Istanbul, 34010

Turkey (Türkiye)

Istanbul Universitesi Cerrahpasa ( Site 0649)

Istanbul, 34098

Turkey (Türkiye)

Recep Tayyip Erdogan University Training and Research Hospital ( Site 0655)

Rize, 53020

Turkey (Türkiye)

Addenbrooke's Hospital ( Site 0747)

Cambridge, Cambridgeshire CB2 2QQ

United Kingdom

St Bartholomew's Hospital ( Site 0749)

London, London, City of EC1A 7BE

United Kingdom

Royal Free Hospital ( Site 0743)

London, London, City of NW3 2QG

United Kingdom

Royal Marsden Hospital (Sutton) ( Site 0741)

London, Surrey SM3 5PT

United Kingdom