Recruiting

Phase 3

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

Sponsor:

Merck Sharp & Dohme LLC

Code:

NCT06925737

Conditions

Prostate Cancer

Prostatic Neoplasms

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Ifinatamab deruxtecan

Docetaxel

Prednisone

Rescue Medication

Study Details

Brief summary:

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.

Conditions

Prostate Cancer

Prostatic Neoplasms

Study ID

NCT06925737

Start date

May 13, 2025

Status verified date

Sep, 2026

Completion date

Jan 6, 2031

Anticipated

Primary completion date

Jun 26, 2028

Anticipated

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

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 prior to Screening
Has current evidence of distant metastatic disease (M1 disease) documented by either bone lesions on bone scan and/or soft tissue disease by computed tomography (CT)/magnetic resonance imaging (MRI)
Has received prior treatment with 1 or 2 androgen receptor pathway inhibitors (ARPIs) and progressed during or after at least 8 weeks of treatment
Has provided tumor tissue from a core or excisional biopsy from soft tissue not previously irradiated and obtained after disease progression on the most recent prior therapy
Has recovered from adverse events (AEs) due to previous anticancer therapies

Exclusion Criteria:

The main exclusion criteria include but are not limited to the following:

Is unable to swallow tablets/capsules
Has any of the following indicators of interstitial lung disease (ILD)/pneumonitis:

1. Has any history of ILD/pneumonitis that required steroid use, except for a history of radiation pneumonitis that did not require steroids
2. Has current ILD/pneumonitis
3. Has a clinical or radiographic suspicion of ILD for which the diagnosis of ILD cannot be ruled out

Has clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses
Has uncontrolled or significant cardiovascular disease
Has received prior treatment with a taxane-based chemotherapy agent for metastatic castration-resistant prostate cancer (mCRPC)
Has had prior discontinuation of an antibody drug conjugate (ADC) that consists of an exatecan derivative (eg, trastuzumab deruxtecan) due to treatment-related toxicities
Has a "superscan" bone scan

Study Design

Enrollment

1440 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: I-DXd

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

active comparator: Docetaxel

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

Interventions

Ifinatamab deruxtecan

Administered via intravenous (IV) infusion every 3 weeks (q3w) until disease progression, unacceptable adverse events (AEs), or other cessation of treatment

Docetaxel

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

Prednisone

Oral tablet administered once per day or per approved product label

Rescue Medication

Before administering each dose of I-DXd, premedication is required for prevention of nausea and vomiting with a 2 or 3 drug combination regimen (eg, corticosteroids with either a 5-HT3 receptor antagonist or an NK-1 receptor antagonist and other drugs as indicated) per approved product label

Primary outcome measure

Overall Survival (OS) [ Time Frame: Up to approximately 36 months ]
Radiographic Progression Free Survival (rPFS) [ Time Frame: Up to approximately 36 months ]

Central Contacts and Locations

Central contacts

Toll Free Number

1-888-577-8839 Trialsites@msd.com

Locations

Mayo Clinic in Arizona - Phoenix ( Site 0044)

Recruiting

Phoenix, Arizona, United States, 85054

Contacts

Study Coordinator

855-776-0015

City of Hope Comprehensive Cancer Center ( Site 0049)

Recruiting

Duarte, California, United States, 91010

Contacts

Study Coordinator

626-256-4673

City of Hope Lennar Foundation Cancer Center ( Site 0059)

Recruiting

Irvine, California, United States, 92618

Contacts

Study Coordinator

626-256-4673

Moores Cancer Center ( Site 0010)

Recruiting

La Jolla, California, United States, 92093

Contacts

Study Coordinator

858-822-6100

Veterans Affairs Long Beach Healthcare System ( Site 0058)

Recruiting

Long Beach, California, United States, 90822

Contacts

Study Coordinator

562-826-8000

Cedars-Sinai Medical Center ( Site 0068)

Recruiting

Los Angeles, California, United States, 90048

Contacts

Study Coordinator

310-423-7600

UCLA Hematology/Oncology - Santa Monica ( Site 0002)

Recruiting

Los Angeles, California, United States, 90404

Contacts

Study Coordinator

310-825-2631

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

Recruiting

Orange, California, United States, 92868

Contacts

Study Coordinator

714-509-2371

Stanford Cancer Center ( Site 0046)

Recruiting

Palo Alto, California, United States, 94304

Contacts

Study Coordinator

650-725-2078

Rocky Mountain Regional Veterans Affairs Medical Center ( Site 0053)

Recruiting

Aurora, Colorado, United States, 80045

Contacts

Study Coordinator

303-399-8020

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

Recruiting

New Haven, Connecticut, United States, 06510

Contacts

Study Coordinator

203-737-6087

Veterans Affairs Connecticut Healthcare System ( Site 0062)

Recruiting

West Haven, Connecticut, United States, 06516

Contacts

Study Coordinator

203-932-5711

The GW Medical Faculty Associates ( Site 0057)

Recruiting

Washington D.C., District of Columbia, United States, 20037

Contacts

Study Coordinator

202-994-2758

Washington DC Veterans Affairs Medical Center ( Site 0056)

Recruiting

Washington D.C., District of Columbia, United States, 20422

Contacts

Study Coordinator

202-745-8000

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

Recruiting

Jacksonville, Florida, United States, 32224

Contacts

Study Coordinator

855-776-0015

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

Recruiting

Atlanta, Georgia, United States, 30303

Contacts

Study Coordinator

404-727-6123

Winship Cancer Institute, Emory University ( Site 0003)

Recruiting

Atlanta, Georgia, United States, 30322

Contacts

Study Coordinator

404-778-4824

Rush University Medical Center-Hematology and Oncology ( Site 0028)

Recruiting

Chicago, Illinois, United States, 60607

Contacts

Study Coordinator

312-563-2531

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

Recruiting

Chicago, Illinois, United States, 60612

Contacts

Study Coordinator

312-355-1625

University of Kentucky Chandler Medical Center ( Site 0048)

Recruiting

Lexington, Kentucky, United States, 40536

Contacts

Study Coordinator

866-340-4488

Greenebaum Comprehensive Cancer Center ( Site 0021)

Recruiting

Baltimore, Maryland, United States, 21201

Contacts

Study Coordinator

410-707-4011

Beth Israel Deaconess Medical Center ( Site 0043)

Recruiting

Boston, Massachusetts, United States, 02215

Contacts

Study Coordinator

617-667-2100

Dana Farber Cancer Institute ( Site 0012)

Recruiting

Boston, Massachusetts, United States, 02215

Contacts

Study Coordinator

617-632-6049

University of Michigan ( Site 0005)

Recruiting

Ann Arbor, Michigan, United States, 48109

Contacts

Study Coordinator

734-647-8902

Henry Ford Hospital ( Site 0035)

Recruiting

Detroit, Michigan, United States, 48202

Contacts

Study Coordinator

313-725-7920

Cancer and Hematology Centers of Western Michigan ( Site 0015)

Recruiting

Grand Rapids, Michigan, United States, 49503

Contacts

Study Coordinator

616-399-6500

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

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Study Coordinator

855-776-0015

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

Recruiting

Saint Louis Park, Minnesota, United States, 55426

Contacts

Study Coordinator

612-341-4800

HealthPartners Cancer Center at Regions Hospital ( Site 0052)

Recruiting

Saint Paul, Minnesota, United States, 55101

Contacts

Study Coordinator

612-341-4800

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

Recruiting

Billings, Montana, United States, 59102

Contacts

Study Coordinator

406-238-6290

Comprehensive Cancer Centers of Nevada ( Site 0082)

Recruiting

Las Vegas, Nevada, United States, 89148

Contacts

Study Coordinator

702-952-1251

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

Recruiting

Hackensack, New Jersey, United States, 07601

Contacts

Study Coordinator

551-996-5900

University of New Mexico Comprehensive Cancer Center ( Site 0022)

Recruiting

Albuquerque, New Mexico, United States, 87131

Contacts

Study Coordinator

505-272-4946

Icahn School of Medicine at Mount Sinai ( Site 0009)

Recruiting

New York, New York, United States, 10029

Contacts

Study Coordinator

212-241-6756

Great Lakes Cancer Care ( Site 0047)

Recruiting

Williamsville, New York, United States, 14221

Contacts

Study Coordinator

716-884-3000

The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive C ( Site 0061)

Recruiting

Columbus, Ohio, United States, 43221

Contacts

Study Coordinator

619-228-4010

VA Portland Health Care System ( Site 0038)

Recruiting

Portland, Oregon, United States, 97239

Contacts

Study Coordinator

503-220-8262

Perelman Center for Advanced Medicine ( Site 0067)

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Study Coordinator

215-360-0737

Abramson Cancer Center - Penn Medicine ( Site 0079)

Recruiting

Philadelphia, Pennsylvania, United States, 19106

Contacts

Study Coordinator

215-829-6088

Memphis VA Medical Center ( Site 0072)

Recruiting

Memphis, Tennessee, United States, 38105

Contacts

Study Coordinator

901-523-8990

SCRI Oncology Partners ( Site 0074)

Recruiting

Nashville, Tennessee, United States, 37203

Contacts

Study Coordinator

615-329-7640

Henry-Joyce Cancer Clinic ( Site 0042)

Recruiting

Nashville, Tennessee, United States, 37232

Contacts

Study Coordinator

615-936-8422

Parkland Health & Hospital System ( Site 0069)

Recruiting

Dallas, Texas, United States, 75235

Contacts

Study Coordinator

214-645-4673

UT Southwestern Medical Center ( Site 0039)

Recruiting

Dallas, Texas, United States, 75390

Contacts

Study Coordinator

972-332-4682

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

Recruiting

Houston, Texas, United States, 77030

Contacts

Study Coordinator

877-632-6789

Blue Ridge Cancer Care ( Site 0024)

Recruiting

Roanoke, Virginia, United States, 24014

Contacts

Study Coordinator

540-982-0237

VA Puget Sound Health Care System ( Site 0054)

Recruiting

Seattle, Washington, United States, 98108

Contacts

Study Coordinator

206-762-1010

Fred Hutchinson Cancer Center ( Site 0060)

Recruiting

Seattle, Washington, United States, 98109

Contacts

Study Coordinator

206-606-7307

University Hospital and UW Health Clinics ( Site 0065)

Recruiting

Madison, Wisconsin, United States, 53792

Contacts

Study Coordinator

608-915-0100

Medical College of Wisconsin ( Site 0008)

Recruiting

Milwaukee, Wisconsin, United States, 53226

Contacts

Study Coordinator

414-805-0509

More Information

Sponsor

Merck Sharp & Dohme LLC

Last update posted

Sep 3, 2026

Last verified

Sep, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Merck Sharp & Dohme LLC on 2026-09-03.