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

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,

CONDITIONS

Prostate Cancer, Prostatic Neoplasms

PRODUCT

I-DXd

GENDER

MALE

AGE

18 Years

SPONSOR

Merck Sharp & Dohme LLC

COLLABORATOR

Daiichi Sankyo

TRIAL RUNS IN

216 Global Locations

A Phase 3, Open-label Study of Ifinatamab Deruxtecan Versus Docetaxel in Participants With Metastatic Castration-Resistant Prostate Cancer (mCRPC) (IDeate-Prostate01)

  • The main inclusion criteria include but are not limited to the following:
  • Has diagnosis of metastatic castration-resistant prostate cancer (mCRPC)
  • Has prostate cancer progression while on androgen deprivation therapy (ADT) (or post bilateral orchiectomy) within 6 months prior to entering the study
  • Has received prior treatment with 1 or 2 androgen receptor pathway inhibitor (ARPI) and progressed during or after at least 8 weeks of treatment
  • The main exclusion criteria include but are not limited to the following:
  • History of (non-infectious) interstitial lung disease (ILD)/pneumonitis that required steroids
  • Has uncontrolled or significant cardiovascular disease
  • Has received prior treatment with a taxane-based chemotherapy agent for mCRPC
This was last updated on 2025-11-06 19:34:19.078.

The content contained is taken is taken directly from public registry ClinicalTrials.gov and has not been edited.

Information about pipeline compounds or investigational uses of compounds does not imply FDA approval for these compounds or uses, nor does it establish the safety or efficacy of these compounds or uses. There is no guarantee that the pipeline compounds or investigational uses will receive FDA approval. Daiichi Sankyo does not recommend or suggest use of its medicines in a manner inconsistent with FDA-approved labeling.