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

Primary Investigator
Reichert, Zachery
Status
OPEN TO ACCRUAL
Phase
III
NCT Number
NCT06925737
UM Number
2025.038
Age Group
Adults
Management Group
CTSU - Oncology
Oncology Group
Genitourinary Oncology
ID (Protocol)
58121
Secondary Protocol No
HUM00271757
Scope
Unspecified
Sponsor Type
Industry
Disease Site
Prostate
Summary
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: Inclusion Criteria
  •   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
Exclusion Criteria
  •   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