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A Phase III, Open-Label Study of Ifinatamab Deruxtecan Versus Docetaxel in Participants with Metastatic Castration-Resistant Prostate Cancer (mCRPC) (IDeate-Prostate01)

Cancer
Arash Rezazadeh Kalebasty
Prostate

Study 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,

Eligibility

  • 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
  • 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
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