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Taking people in ThailandPhase 3

Testing ifinatamab deruxtecan against docetaxel in advanced prostate cancer

Compares a study medicine with chemotherapy in men with advanced prostate cancer.

Key facts

Who runs it
Merck Sharp & Dohme LLC
Where
Bangkoknoi and Dusit, ThailandSee the 2 sitesAlso in 34 other countries, 299 sites
Trial code
Registry title
A Clinical Study of Ifinatamab Deruxtecan (I-DXd) in People With Metastatic Prostate Cancer (MK-2400-001)
Status
Recruiting
Phase
Phase 3
People taking part
1,440 people, planned
Started
13 May 2025
Expected to end
6 Jan 2031
Type of study
Interventional, 2 groupsOne group gets an existing treatment, for comparison.
Treatments tested
  • Ifinatamab deruxtecan
  • Docetaxel
  • Prednisone
  • Rescue Medication
Record updated
30 October 2026

Who can take part

AI summary

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

The registry criteria, word for word

Show all 15 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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

Where in Thailand

Also in 34 other countries, 299 sites

  • Faculty of Medicine Siriraj Hospital (Site 0885)Bangkoknoi, ThailandContact: Study CoordinatorTaking people
  • Bangkok Metropolitan Administration Medical College and Vajira Hospital (Site 0887)Dusit, ThailandContact: Study CoordinatorTaking people

About the trial

What the trial wants to find out

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.

The 2 groups in the trial

  • I-DXdTreatment being tested

    Participants receive I-DXd 12mg/kg every 3 weeks (q3w)

    Treatment: Ifinatamab deruxtecan and Rescue Medication

  • DocetaxelExisting treatment, for comparison

    Participants receive docetaxel 75 mg/m\^2 q3w and prednisone 10 mg/day or per approved product label

    Treatment: Docetaxel and Prednisone

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
Official title
A Phase 3, Open-label Study of Ifinatamab Deruxtecan Versus Docetaxel in Participants With Metastatic Castration-Resistant Prostate Cancer (mCRPC) (IDeate-Prostate01)
Plain-language title
Testing ifinatamab deruxtecan against docetaxel in advanced prostate cancerGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
30 October 2026