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Looking for participantsPhase3

A Clinical Study of Ifinatamab Deruxtecan (I-DXd) in People With Metastatic Prostate Cancer (MK-2400-001)

Sponsor: Merck Sharp & Dohme LLC

NCT ID: NCT06925737

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Ifinatamab deruxtecan (drug), Docetaxel (drug), Prednisone (drug), Rescue Medication (drug)
How long the study runs
Study runs about 68 months (dates as stated)
About the drug or intervention
Ifinatamab deruxtecan — drug: Administered via intravenous (IV) infusion every 3 weeks (q3w) until disease progression, unacceptable adverse events (AEs), or other cessation of treatment · Docetaxel — drug: Administered via IV infusion q3W until disease progression, unacceptable adverse events (AEs), or other cessation of treatment · Prednisone — drug: Oral tablet administered once per day or per approved product label · Rescue Medication — drug: 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
Patient visit burden
Not specified by the sponsor
Type of study
Testing a treatment
Ages
18 Years and over
Who
Male
Number of participants
1,440
Started
2025-05-13
Last checked
2026-10

Plain English Summary

What is this study?

  • • Testing a new treatment for prostate cancer
  • • Phase3 - 1,440 participants
  • • Researchers are looking for new ways to treat metastatic castration-resistant prostate cancer (mCRPC)

Who can take part?

  • • Ages 18 Years and over
  • • Diagnosed with prostate cancer
  • • Male only

Where?

  • • Cambridge - Addenbrooke's Hospital ( Site 0915)
  • • London - University College London Hospital ( Site 0920)
  • • Exeter - Royal Devon & Exeter Hospital ( Site 0924)
  • • Birmingham - Queen Elizabeth Hospital Birmingham ( Site 0923)
  • • +4 more UK sites

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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.

Prostate CancerProstatic Neoplasms

How this trial compares with your answers

Answer 2 more questions to improve match

What we know so far

Condition· Matched your search
Age· Tell us your age for better matching
Gender· Tell us your sex for better matching

Still need:

  • • Tell us your age for better matching
  • • Tell us your sex for better matching

Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years and over
  • Who can join: Male only

What the study is looking for

  • ✓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...
  • ✓Has current evidence of distant that has spread disease (M1 disease) documented by either bone lesions on bone scan...
  • ✓Has received prior treatment with 1 or 2 androgen receptor pathway inhibitors (ARPIs) and progressed during or after...

Who cannot take part

  • ✗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...
  • ✗Has current ILD/pneumonitis
See the full criteria
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

Where Is This Study? (8 UK sites)

Addenbrooke's Hospital ( Site 0915)

Cambridge CB2 2QQ, United Kingdom

Recruiting
Site contact (verified)
Study Coordinator+441223805000

University College London Hospital ( Site 0920)

London NW1 2PG, United Kingdom

Recruiting
Site contact (verified)
Study Coordinator+442034477729

Royal Devon & Exeter Hospital ( Site 0924)

Exeter EX2 5DW, United Kingdom

ACTIVE_NOT_RECRUITING
Hospital R&D contact (matched)

Samantha Smart

rduh.research-eastern@nhs.net01392 406075

Queen Elizabeth Hospital Birmingham ( Site 0923)

Birmingham B15 2TH, United Kingdom

Recruiting
Site contact (verified)
Study Coordinator+441216272000

Mount Vernon Hospital ( Site 0921)

Northwood HA6 2RN, United Kingdom

Recruiting
Site contact (verified)
Study Coordinator0203 826 2020

St Bartholomew s Hospital ( Site 0925)

London EC1A 7BE, United Kingdom

Recruiting
Site contact (verified)
Study Coordinator020 7377 7000

Royal Marsden Hospital (Sutton) ( Site 0922)

Sutton SM2 5PT, United Kingdom

Recruiting
Site contact (verified)
Study Coordinator+4402087224191

Torbay Hospital ( Site 0918)

Devon TQ2 7AA, United Kingdom

Recruiting
Site contact (verified)
Study Coordinator+441803656615

How to Get in Touch

Toll Free Number

Sponsor contact

CONTACT

1-888-577-8839 Trialsites@msd.com
Data sourced from ClinicalTrials.gov · Last verified: 2026-10