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

What this study is about

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.

Who can join (things the study team will check)

✅ You may be able to join if…

• 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

🚫 You may not be able to join if…

• Is unable to swallow tablets/capsules
• 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
• 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
• Has a "superscan" bone scan

Where this trial is running

• Mayo Clinic in Arizona - Phoenix ( Site 0044), Phoenix, Arizona, United States
• City of Hope Comprehensive Cancer Center ( Site 0049), Duarte, California, United States
• City of Hope Lennar Foundation Cancer Center ( Site 0059), Irvine, California, United States
• Moores Cancer Center ( Site 0010), La Jolla, California, United States
• Veterans Affairs Long Beach Healthcare System ( Site 0058), Long Beach, California, United States
• Cedars-Sinai Medical Center ( Site 0068), Los Angeles, California, United States
• UCLA Hematology/Oncology - Santa Monica ( Site 0002), Los Angeles, California, United States
• University of California, Irvine (UCI) Health - UC Irvine Medical Center ( Site 0006), Orange, California, United States
• Stanford Cancer Center ( Site 0046), Palo Alto, California, United States
• Rocky Mountain Regional Veterans Affairs Medical Center ( Site 0053), Aurora, Colorado, United States
• Yale-New Haven Hospital-Yale Cancer Center ( Site 0050), New Haven, Connecticut, United States
• Veterans Affairs Connecticut Healthcare System ( Site 0062), West Haven, Connecticut, United States

+ 284 more sites.

Who to contact

Toll Free Number · 1-888-577-8839 · Trialsites@msd.com

It's completely normal to call and ask questions before deciding anything. Mention the study ID: NCT06925737.