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NCT06925737

A Clinical Study of Ifinatamab Deruxtecan (I-DXd) in People With Metastatic Prostate Cancer (MK-2400-001)

Last Updated: 2025-12-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

1440 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-05-13

Study Completion Date

2031-01-06

Brief Summary

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Researchers are looking for new ways to treat metastatic castration-resistant prostate cancer (mCRPC). Researchers have designed a study medicine called ifinatamab deruxtecan (also called I-DXd or MK-2400) to treat mCRPC. The goal of this study is to learn if people who receive I-DXd live longer overall and live longer without the cancer growing or spreading than people who receive chemotherapy,

Detailed Description

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Conditions

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Prostate Cancer Prostatic Neoplasms

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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I-DXd

Participants receive I-DXd 12mg/kg every 3 weeks (q3w)

Group Type EXPERIMENTAL

Ifinatamab deruxtecan

Intervention Type DRUG

Administered via intravenous (IV) infusion every 3 weeks (q3W) until disease progression, unacceptable adverse events (AEs), or other cessation of treatment

Docetaxel

Participants receive docetaxel 75 mg//m\^2 q3w and prednisone 10 mg/day or per approved product label

Group Type ACTIVE_COMPARATOR

Docetaxel

Intervention Type DRUG

Administered via IV infusion q3W until disease progression, unacceptable adverse events (AEs), or other cessation of treatment

Prednisone

Intervention Type DRUG

Oral tablet administered once per day or per approved product label

Interventions

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Ifinatamab deruxtecan

Administered via intravenous (IV) infusion every 3 weeks (q3W) until disease progression, unacceptable adverse events (AEs), or other cessation of treatment

Intervention Type DRUG

Docetaxel

Administered via IV infusion q3W until disease progression, unacceptable adverse events (AEs), or other cessation of treatment

Intervention Type DRUG

Prednisone

Oral tablet administered once per day or per approved product label

Intervention Type DRUG

Other Intervention Names

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I-DXd MK-2400 Prednisone acetate Prednisolone Prednisolone acetate

Eligibility Criteria

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Inclusion Criteria

* Has diagnosis of metastatic castration-resistant prostate cancer (mCRPC)
* Has prostate cancer progression while on androgen deprivation therapy (ADT) (or post bilateral orchiectomy) within 6 months prior to entering the study
* Has received prior treatment with 1 or 2 androgen receptor pathway inhibitor (ARPI) and progressed during or after at least 8 weeks of treatment

Exclusion Criteria

* History of (non-infectious) interstitial lung disease (ILD)/pneumonitis that required steroids
* Has uncontrolled or significant cardiovascular disease
* Has received prior treatment with a taxane-based chemotherapy agent for mCRPC

Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Director

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

Locations

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Mayo Clinic in Arizona - Phoenix ( Site 0044)

Phoenix, Arizona, United States

Site Status RECRUITING

City of Hope Comprehensive Cancer Center ( Site 0049)

Duarte, California, United States

Site Status RECRUITING

City of Hope Lennar Foundation Cancer Center ( Site 0059)

Irvine, California, United States

Site Status RECRUITING

Moores Cancer Center ( Site 0010)

La Jolla, California, United States

Site Status RECRUITING

Cedars-Sinai Medical Center ( Site 0068)

Los Angeles, California, United States

Site Status RECRUITING

UCLA Hematology/Oncology - Santa Monica ( Site 0002)

Los Angeles, California, United States

Site Status RECRUITING

University of California, Irvine (UCI) Health - UC Irvine Medical Center ( Site 0006)

Orange, California, United States

Site Status RECRUITING

Yale-New Haven Hospital-Yale Cancer Center ( Site 0050)

New Haven, Connecticut, United States

Site Status RECRUITING

Washington DC Veterans Affairs Medical Center ( Site 0056)

Washington D.C., District of Columbia, United States

Site Status RECRUITING

Mayo Clinic in Florida-Mayo Clinic Comprehensive Cancer Center ( Site 0077)

Jacksonville, Florida, United States

Site Status RECRUITING

Emory University School of Medicine- Grady Campus ( Site 0103)

Atlanta, Georgia, United States

Site Status RECRUITING

Winship Cancer Institute, Emory University ( Site 0003)

Atlanta, Georgia, United States

Site Status RECRUITING

University of Illinois at Chicago-University of Illinois Cancer Center ( Site 0063)

Chicago, Illinois, United States

Site Status RECRUITING

University of Kentucky Chandler Medical Center ( Site 0048)

Lexington, Kentucky, United States

Site Status RECRUITING

Greenebaum Comprehensive Cancer Center ( Site 0021)

Baltimore, Maryland, United States

Site Status RECRUITING

Beth Israel Deaconess Medical Center ( Site 0043)

Boston, Massachusetts, United States

Site Status RECRUITING

Dana Farber Cancer Institute ( Site 0012)

Boston, Massachusetts, United States

Site Status RECRUITING

University of Michigan ( Site 0005)

Ann Arbor, Michigan, United States

Site Status RECRUITING

Henry Ford Hospital ( Site 0035)

Detroit, Michigan, United States

Site Status RECRUITING

Cancer and Hematology Centers of Western Michigan ( Site 0015)

Grand Rapids, Michigan, United States

Site Status RECRUITING

Mayo Clinic in Rochester, Minnesota-Mayo Clinic Comprehensive Cancer Center ( Site 0078)

Rochester, Minnesota, United States

Site Status RECRUITING

HealthPartners Cancer Research Center-HealthPartners Frauenshuh Cancer Center ( Site 0032)

Saint Louis Park, Minnesota, United States

Site Status RECRUITING

HealthPartners Cancer Center at Regions Hospital ( Site 0052)

Saint Paul, Minnesota, United States

Site Status RECRUITING

St. Vincent Frontier Cancer Center-Research ( Site 0037)

Billings, Montana, United States

Site Status RECRUITING

Oncology Hematology West, PC dba Nebraska Cancer Specialists - Grand Island ( Site 0076)

Grand Island, Nebraska, United States

Site Status RECRUITING

Oncology Hematology West P.C. dba Nebraska Cancer Specialists ( Site 0026)

Omaha, Nebraska, United States

Site Status RECRUITING

John Theurer Cancer Center at Hackensack University Medical Center ( Site 0016)

Hackensack, New Jersey, United States

Site Status RECRUITING

Icahn School of Medicine at Mount Sinai ( Site 0009)

New York, New York, United States

Site Status RECRUITING

Great Lakes Cancer Care ( Site 0047)

Williamsville, New York, United States

Site Status RECRUITING

Perelman Center for Advanced Medicine ( Site 0067)

Philadelphia, Pennsylvania, United States

Site Status RECRUITING

Abramson Cancer Center - Penn Medicine ( Site 0079)

Philadelphia, Pennsylvania, United States

Site Status RECRUITING

Memphis VA Medical Center ( Site 0072)

Memphis, Tennessee, United States

Site Status RECRUITING

SCRI Oncology Partners ( Site 0074)

Nashville, Tennessee, United States

Site Status RECRUITING

UT Southwestern Medical Center ( Site 0039)

Dallas, Texas, United States

Site Status RECRUITING

University of Texas-MD Anderson Cancer Center ( Site 0055)

Houston, Texas, United States

Site Status RECRUITING

Blue Ridge Cancer Care ( Site 0024)

Roanoke, Virginia, United States

Site Status RECRUITING

VA Puget Sound Health Care System ( Site 0054)

Seattle, Washington, United States

Site Status RECRUITING

Fred Hutchinson Cancer Center ( Site 0060)

Seattle, Washington, United States

Site Status RECRUITING

Centro de Oncologia e Investigacion Buenos Aires COIBA ( Site 0136)

Berazategui, Buenos Aires, Argentina

Site Status RECRUITING

Instituto de Investigaciones Clinicas Mar del Plata ( Site 0129)

Mar del Plata, Buenos Aires, Argentina

Site Status RECRUITING

Instituto Alexander Fleming ( Site 0125)

Mar del Plata, Buenos Aires, Argentina

Site Status RECRUITING

Sanatorio Parque ( Site 0126)

Rosario, Santa Fe Province, Argentina

Site Status RECRUITING

Centro Medico Dra De Salvo ( Site 0132)

CABA, , Argentina

Site Status RECRUITING

Fundación CORI para la Investigación y Prevención del Cáncer ( Site 0131)

La Rioja, , Argentina

Site Status RECRUITING

Centro Oncologico de Integracion Regional. COIR ( Site 0130)

Mendoza, , Argentina

Site Status RECRUITING

Centro de Diagnostico Investigación y Tratamiento Oncológico (CeDIT) ( Site 0135)

Salta, , Argentina

Site Status RECRUITING

Instituto San Marcos ( Site 0137)

San Juan, , Argentina

Site Status RECRUITING

Blacktown Hospital ( Site 0154)

Blacktown, New South Wales, Australia

Site Status RECRUITING

Macquarie University-MQ Health Clinical Trials Unit ( Site 0151)

Macquarie University, New South Wales, Australia

Site Status RECRUITING

Gallipoli Medical Research Ltd ( Site 0153)

Greenslopes, Queensland, Australia

Site Status RECRUITING

Peter MacCallum Cancer Centre ( Site 0152)

Melbourne, Victoria, Australia

Site Status RECRUITING

Ordensklinikum Linz GmbH Elisabethinen-Urologie ( Site 0170)

Linz, Upper Austria, Austria

Site Status RECRUITING

Klinikum Wels-Grieskirchen GmbH ( Site 0171)

Wels, Upper Austria, Austria

Site Status RECRUITING

Uniklinikum Salzburg Universitaetsklinik für Innere Medizin III ( Site 0172)

Salzburg, , Austria

Site Status RECRUITING

Hospital Mario Penna ( Site 0179)

Belo Horizonte, Minas Gerais, Brazil

Site Status RECRUITING

Hospital Universitário Evangélico Mackenzie ( Site 0181)

Curitiba, Paraná, Brazil

Site Status RECRUITING

Irmandade da Santa Casa de Misericórdia de Porto Alegre ( Site 0184)

Porto Alegre, Rio Grande do Sul, Brazil

Site Status RECRUITING

Hospital de Base de São José do Rio Preto ( Site 0176)

São José do Rio Preto, São Paulo, Brazil

Site Status RECRUITING

IPITEC ( Site 0189)

São Paulo, , Brazil

Site Status RECRUITING

IBCC - Núcleo de Pesquisa e Ensino ( Site 0183)

São Paulo, , Brazil

Site Status RECRUITING

FALP ( Site 0201)

Santiago, Region M. de Santiago, Chile

Site Status RECRUITING

Bradfordhill ( Site 0200)

Santiago, Region M. de Santiago, Chile

Site Status RECRUITING

Peking University First Hospital ( Site 1434)

Beijing, Beijing Municipality, China

Site Status RECRUITING

Shanghai General Hospital ( Site 1449)

Beijing, Beijing Municipality, China

Site Status RECRUITING

The First Affiliated Hospital of Chonqing Medical University ( Site 1406)

Chongqing, Chongqing Municipality, China

Site Status RECRUITING

Chongqing University Three Gorges Hospital ( Site 1405)

Chongqing, Chongqing Municipality, China

Site Status RECRUITING

The First Affiliated Hospital Of Fujian Medical University ( Site 1452)

Fuzhou, Fujian, China

Site Status RECRUITING

Guangzhou First People's Hospital ( Site 1410)

Guangzhou, Guangdong, China

Site Status RECRUITING

Sun Yat-Sen University Cancer Center ( Site 1467)

Guangzhou, Guangdong, China

Site Status RECRUITING

Sun Yat-sen Memorial Hospital, Sun Yat-sen University ( Site 1402)

Guangzhou, Guangdong, China

Site Status RECRUITING

Sun Yat-sen University Cancer Center ( Site 1409)

Guangzhou, Guangdong, China

Site Status RECRUITING

The Fifth Affiliated Hospital of Sun Yat-Sen University ( Site 1459)

Zhuhai, Guangdong, China

Site Status RECRUITING

Guangxi Medical University Cancer Hospital ( Site 1414)

Nanning, Guangxi, China

Site Status RECRUITING

Henan Cancer Hospital ( Site 1472)

Zhengzhou, Henan, China

Site Status RECRUITING

Union Hospital Tongji Medical College Huazhong University of Science and Technology ( Site 1424)

Wuhan, Hubei, China

Site Status RECRUITING

Hunan Cancer Hospital ( Site 1411)

Changsha, Hunan, China

Site Status RECRUITING

Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School ( Site 1425)

Nanjing, Jiangsu, China

Site Status RECRUITING

Jiangsu Province Hospital ( Site 1426)

Nanjing, Jiangsu, China

Site Status RECRUITING

Zhongda Hospital Southeast University ( Site 1427)

Nanjing, Jiangsu, China

Site Status RECRUITING

The Affiliated Hospital of Xuzhou Medical University ( Site 1438)

Xuzhou, Jiangsu, China

Site Status RECRUITING

Jilin Province People's Hospital ( Site 1461)

Changchun, Jilin, China

Site Status RECRUITING

The first affiliated Hospital of Xi an Jiaotong University ( Site 1408)

Xi'an, Shaanxi, China

Site Status RECRUITING