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Clinical Trial ● Currently Recruiting Phase III NCT06925737

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

A Clinical Study of Ifinatamab Deruxtecan (I-DXd) in People With Metastatic Prostate Cancer (MK-2400-001) — Recruiting • Phase III • Oncology • NCT06925737.

📅 15 May 2026 ⏱ 2 min read
Currently Recruiting
This trial is actively seeking participants in the UK. Discuss eligibility with your patient before referring.
Status
Currently Recruiting
Phase
Phase III
NCT ID
NCT06925737
Sponsor
Merck Sharp & Dohme LLC
Start
2025-05-13
ClinicaliQ Trial Snapshot
  • A Clinical Study of Ifinatamab Deruxtecan (I-DXd) in People With Metastatic Prostate Cancer (MK-2400-001) — Recruiting • Phase III • Oncology • NCT06925737.
  • What is being tested: Ifinatamab deruxtecan (I-DXd/MK-2400), a novel targeted therapy designed to treat metastatic castration-resistant prostate cancer (mCRPC), with the primary objective of evaluating its efficacy and safety profile in this patient population.
  • Patient eligibility overview: The study targets men with mCRPC who have progressed despite castration therapy; specific eligibility criteria typically include confirmed metastatic disease, adequate organ function, and prior treatment history, though full criteria would be detailed in the protocol.
Use This Page For
  • Quick orientation before opening the registry record.
  • Checking recruitment status, phase and sponsor at a glance.
  • Connecting this trial to nearby guidelines, Drug Science and education.
What This Trial Is Studying

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 Snapshot
  • : 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

Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.

Full Trial Details
View this trial on the source registry
Eligibility criteria, protocol, and results when available
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