NCT06925737Recruiting
A Clinical Study of Ifinatamab Deruxtecan (I-DXd) in People With Metastatic Prostate Cancer (MK-2400-001)
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.
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
Contacts
The trial team's contact details are shown on request.
See the official trial record- Status
- Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Countries
- Switzerland, France, Germany, Italy, Austria, United States, Argentina, Australia, Brazil, Chile, China, Colombia, Czechia, Denmark, Greece, Guatemala, Hong Kong, Ireland, Israel, Japan, Malaysia, Mexico, Netherlands, Norway, Peru, Poland, Singapore, South Africa, South Korea, Spain, Sweden, Taiwan, Thailand, Turkey (Türkiye), United Kingdom
- Sponsor
- Merck Sharp & Dohme LLC(Industry)
- Protocol no.
- 2400-001
- Conditions
- Prostate Cancer, Prostatic Neoplasms
- Interventions
- Drug
Treatments studied
- Ifinatamab deruxtecan
- Docetaxel
- Prednisone
- Rescue Medication
Collaborators
Daiichi Sankyo
Locations · 290
- Aarau, SwitzerlandKantonspital Aarau ( Site 0857)Recruiting at this site
- Basel, SwitzerlandUniversity Hospital Basel ( Site 0859)Recruiting at this site
- Geneva, SwitzerlandHopitaux Universitaires de Geneve HUG. ( Site 0856)Recruiting at this site
- Fribourg, SwitzerlandHFR Fribourg - Hôpital Cantonal ( Site 0858)Recruiting at this site
- Zurich, SwitzerlandStadtspital Zürich Triemli ( Site 0855)Recruiting at this site
- Suresnes, FranceHôpital Foch ( Site 0309)Recruiting at this site
- Strasbourg, FranceHopitaux Universitaires de Strasbourg- Hopital de Hautepierre ( Site 0314)Recruiting at this site
- Marseille, FranceHôpital Privé Clairval ( Site 0303)Recruiting at this site
- Caen, FranceCentre François Baclesse ( Site 0311)Recruiting at this site
- Nîmes, FranceCentre Hospitalier Universitaire de Nîmes - Institut de Canc-Medical Oncology ( Site 0313)Recruiting at this site
- Limoges, FranceClinique Francois Chenieux ( Site 0312)Recruiting at this site
- Vandœuvre-lès-Nancy, FranceInstitut de Cancérologie de Lorraine Alexis Vautrin ( Site 0307)Recruiting at this site
- Rouen, FranceCHU de Rouen ( Site 0301)Recruiting at this site
- Paris, FranceHôpital Saint-Louis ( Site 0310)Recruiting at this site
- Nürtingen, GermanyStudienpraxis Urologie ( Site 0358)Recruiting at this site
- Stuttgart, GermanyKlinikum Stuttgart - Katharinenhospital ( Site 0355)Recruiting at this site
- Munich, GermanyKlinikum der Universität München Großhadern ( Site 0366)Recruiting at this site
- Munich, Germanyklinikum rechts der isar der technischen universität münchen ( Site 0350)Recruiting at this site
- Nuremberg, GermanyKlinikum Nuernberg Nord ( Site 0353)Recruiting at this site
- Potsdam, GermanyLOGICURO GmbH ( Site 0364)Recruiting at this site
- Frankfurt am Main, GermanyUniversitätsklinikum Frankfurt Goethe-Universität ( Site 0354)Recruiting at this site
- Cologne, GermanyStudienzentrum Bayenthal Urologische Partnerschaft Koln ( Site 0365)Recruiting at this site
- Duisburg, GermanyUrologicum Duisburg ( Site 0361)Recruiting at this site
- Mainz, GermanyUniversitätsmedizin Johannes Gutenberg Universität Mainz ( Site 0362)Recruiting at this site
- Lübeck, GermanyUniversitaetsklinikum Schleswig Holstein ( Site 0360)Recruiting at this site
- Berlin, GermanyCharité Universitaetsmedizin Berlin - Campus Mitte ( Site 0352)Recruiting at this site
- Hamburg, GermanyUniversitaetsklinik Hamburg-Eppendorf ( Site 0351)Recruiting at this site
- Milan, ItalyFondazione IRCCS Istituto Nazionale dei Tumori ( Site 0500)Recruiting at this site
- Rozzano, ItalyIstituto Clinico Humanitas ( Site 0504)Recruiting at this site
- Rome, ItalyIstituto Nazionale Tumori Regina Elena ( Site 0507)Recruiting at this site
In total, worldwide, 290 of the 303 sites listed in the registry are recruiting; the other 13 are not currently recruiting.
Site status per the ClinicalTrials.gov registry (last update posted: October 15, 2026).
This status may have changed and says nothing about your eligibility: before taking any step, check with your oncologist or the site.
+ 260 more locations
Other identifiers
- U1111-1312-2498 · other registry
- 2024-517423-40-00 · other registry
- MK-2400-001 · other identifier
See also
Other versions
These results are indicative and do not replace medical advice — discuss them with your doctor.