Testing ifinatamab deruxtecan against docetaxel in advanced prostate cancer
Compares a study medicine with chemotherapy in men with advanced prostate cancer.
Plain-language title generated from the registry record
Registry title: A Clinical Study of Ifinatamab Deruxtecan (I-DXd) in People With Metastatic Prostate Cancer (MK-2400-001)
Key facts
- Where
- Guadalajara, Mexico City, Monterrey, Oaxaca City, and Pachuca, MexicoSee the 6 sites
- Phase
- Phase 3
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for men with prostate cancer that has spread and no longer responds to hormone-lowering treatment. It compares ifinatamab deruxtecan with docetaxel chemotherapy.
- Age
- 18 years or older
- Sex
- Men only
- Disease stage
- Prostate adenocarcinoma (not small cell) that has spread to distant sites, with growth despite androgen deprivation therapy within the last 6 months
- Earlier treatment
- Must have had 1 or 2 androgen receptor pathway inhibitors and progressed during or after at least 8 weeks of treatment. Must not have had taxane chemotherapy for metastatic castration-resistant prostate cancer.
- Biomarker or test result
- A tumor tissue sample from a soft tissue biopsy, not previously irradiated and taken after the latest progression, must be provided
Main reasons for not taking part
- Cannot swallow tablets or capsules
- Past or current interstitial lung disease or pneumonitis that needed steroids
- Severe lung problems from other lung illnesses
- Uncontrolled or significant heart or blood vessel disease
- Stopped an earlier exatecan-derivative antibody drug conjugate (such as trastuzumab deruxtecan) because of side effects
Read by machine on 10 November 2026.
Where in Mexico
- CIO - Centro de Inmuno-Oncología de Occidente (Site 0541)Guadalajara, MexicoTaking people
- Higiea Oncologia (Site 0542)Mexico City, MexicoTaking people
- Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran (Site 0545)Mexico City, MexicoTaking people
- Laboratorio de Patología Clínica del Hospital Universitario "Dr. José Eleuterio González" (Site 0540)Monterrey, MexicoTaking people
- Centro de Investigacion Clinica de Oaxaca (Site 0543)Oaxaca City, MexicoTaking people
- Grupo Ollin Care (Site 0544)Pachuca, MexicoTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Merck Sharp & Dohme LLC
- Trial code
- NCT06925737EU 2024-517423-40-00
- Record updated
- 30 October 2026
- Original description
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.Read full original descriptionShow less
A Phase 3, Open-label Study of Ifinatamab Deruxtecan Versus Docetaxel in Participants With Metastatic Castration-Resistant Prostate Cancer (mCRPC) (IDeate-Prostate01)
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: 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: 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 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; The main exclusion criteria include but are not limited to the following:; Is unable to swallow tablets/capsules; Has a "superscan" bone scan.