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

Prior treatment

• 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

Other illness

• 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 not require steroids
  • Has current ILD/pneumonitis
  • 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

Other

• The main exclusion criteria include but are not limited to the following:
• Is unable to swallow tablets/capsules
• Has a "superscan" bone scan

• 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