Last updated 6 days ago
A Clinical Study of Ifinatamab Deruxtecan (I-DXd) in People With Metastatic Prostate Cancer (MK-2400-001)
1440 patients around the world
Available in Mexico, Guatemala, Argentina, United States
Merck Sharp & Dohme LLC
33Research sites
1440Patients around the world
This study is for people with
Prostate cancer
Metastatic prostate cancer
Castration resistant prostate cancer
Requirements for the patient
From 18 Years
Male
Medical requirements
- 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.
- 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.Has any history of ILD/pneumonitis that required steroid use, except for a history of radiation pneumonitis that did not require steroids.Has current ILD/pneumonitis.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.
Sites
Fundación Cori para la Investigación y Prevención del Cáncer - La Rioja
Recruiting
Instituto de Investigaciones Clínicas Mar del Plata
Recruiting
Instituto San Marcos Investigación - San Juan
Recruiting
Centro Oncológico de Integración Regional C.O.I.R. - Mendoza
Recruiting
Centro de Diagnóstico Investigación y Tratamiento - CEDIT - Salta
Recruiting
Fundación Respirar
Recruiting
Instituto Médico Especializado Alexander Fleming - CABA, Buenos Aires
Recruiting
Sanatorio Parque - Rosario
Recruiting
Centro de Oncología e Investigación Buenos Aires COIBA
Recruiting
Instituto Mário Penna
Recruiting
StudyIDeate-Prostate01
SponsorMerck Sharp & Dohme LLC
Study typeInterventional
Conditions
Metastatic prostate cancerCastration resistant prostate cancer
Requirements
From 18 YearsMale
Unique study IDclinicaltrials.gov
NCT06925737
