A Clinical Study of Ifinatamab Deruxtecan (I-DXd) in People With Metastatic Prostate Cancer (MK-2400-001)
A Phase 3, Open-label Study of Ifinatamab Deruxtecan Versus Docetaxel in Participants With Metastatic Castration-Resistant Prostate Cancer (mCRPC) (IDeate-Prostate01)
Merck Sharp & Dohme LLC
1,440 participants
May 13, 2025
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria6
- 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 Criteria10
- 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
Interventions
Administered via intravenous (IV) infusion every 3 weeks (q3w) until disease progression, unacceptable adverse events (AEs), or other cessation of treatment
Administered via IV infusion q3W until disease progression, unacceptable adverse events (AEs), or other cessation of treatment
Oral tablet administered once per day or per approved product label
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
Locations(274)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06925737