A Clinical Study of Ifinatamab Deruxtecan (I-DXd) in People With Metastatic Prostate Cancer (MK-2400-001)
Trial Status: active
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.
Inclusion Criteria
- 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 sponsor and potential other locations can be found on ClinicalTrials.gov for NCT06925737.
Locations matching your search criteria
United States
Arizona
Scottsdale
Mayo Clinic in Arizona
Status: Active
Name Not AvailableCalifornia
Duarte
City of Hope Comprehensive Cancer Center
Status: Active
Name Not AvailableIrvine
City of Hope at Irvine Lennar
Status: Active
Contact: Charles B Nguyen
Phone: 949-780-5454
Email: charnguyen@coh.org
La Jolla
UC San Diego Moores Cancer Center
Status: Active
Name Not AvailableLos Angeles
UCLA / Jonsson Comprehensive Cancer Center
Status: Active
Contact: Soheila Abbassi
Phone: 424-410-9033
Email: Sabbassi@mednet.ucla.edu
Orange
UC Irvine Health/Chao Family Comprehensive Cancer Center
Status: Active
Name Not AvailablePalo Alto
Stanford Cancer Institute Palo Alto
Status: Approved
Name Not AvailableConnecticut
New Haven
Yale University
Status: Active
Name Not AvailableNorth Haven
Yale-New Haven Hospital North Haven Medical Center
Status: Active
Name Not AvailableStamford
Smilow Cancer Hospital Care Center at Long Ridge
Status: Active
Name Not AvailableTrumbull
Smilow Cancer Hospital Care Center-Trumbull
Status: Active
Name Not AvailableFlorida
Jacksonville
Mayo Clinic in Florida
Status: Active
Name Not AvailableGeorgia
Atlanta
Emory Saint Joseph's Hospital
Status: Active
Contact: Mehmet Asim Bilen
Phone: 404-778-3693
Email: mehmet.a.bilen@emory.edu
Emory University Hospital Midtown
Status: Active
Name Not AvailableGrady Health System
Status: Active
Name Not AvailableEmory University Hospital/Winship Cancer Institute
Status: Active
Name Not AvailableKentucky
Lexington
University of Kentucky/Markey Cancer Center
Status: Active
Name Not AvailableMaryland
Baltimore
University of Maryland/Greenebaum Cancer Center
Status: Active
Contact: Shawn Adams
Phone: 410-328-8610
Email: shawn.adams@umm.edu
Massachusetts
Boston
Dana-Farber Cancer Institute
Status: Active
Name Not AvailableBrigham and Women's Hospital
Status: Active
Name Not AvailableMichigan
Ann Arbor
University of Michigan Rogel Cancer Center
Status: Active
Name Not AvailableMinnesota
Rochester
Mayo Clinic in Rochester
Status: Active
Name Not AvailableNew Jersey
Hackensack
Hackensack University Medical Center
Status: Active
Name Not AvailableNew Mexico
Albuquerque
University of New Mexico Cancer Center
Status: Active
Name Not AvailableNew York
New York
Icahn School of Medicine at Mount Sinai
Status: Active
Name Not AvailableOhio
Columbus
Ohio State University Comprehensive Cancer Center
Status: Active
Name Not AvailablePennsylvania
Philadelphia
University of Pennsylvania/Abramson Cancer Center
Status: Active
Name Not AvailableTexas
Dallas
UT Southwestern/Simmons Cancer Center-Dallas
Status: Active
Name Not AvailableHouston
M D Anderson Cancer Center
Status: Active
Name Not AvailableWashington
Seattle
Fred Hutch/University of Washington/Seattle Children's Cancer Consortium
Status: Active
Name Not AvailableWisconsin
Madison
University of Wisconsin Carbone Cancer Center - University Hospital
Status: Active
Name Not AvailableTrial PhasePhase III
Trial Typetreatment
Lead OrganizationMerck Sharp and Dohme LLC
- Primary ID2400-001
- Secondary IDsNCI-2025-03471, 2024-517423-40, 2024-517423-40-00, MK-2400-001, U1111-1312-2498
- ClinicalTrials.gov IDNCT06925737