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

Recruiting now · Phase 3

Conditions studied: Prostate Cancer, Prostatic Neoplasms

In brief

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.

Key facts

Study ID

NCT06925737

Run by

Merck Sharp & Dohme LLC

People needed

1440

Starts

2025-05-13

Expected to finish

2031-01-06

Last updated by the study team

2026-07-17

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• The main exclusion criteria include but are not limited to the following:
• 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 it is running

• City of Hope Comprehensive Cancer Center ( Site 0049) — Duarte, California, United States (enrolling)
• City of Hope Lennar Foundation Cancer Center ( Site 0059) — Irvine, California, United States (enrolling)
• Moores Cancer Center ( Site 0010) — La Jolla, California, United States (enrolling)
• Veterans Affairs Long Beach Healthcare System ( Site 0058) — Long Beach, California, United States (enrolling)
• Cedars-Sinai Medical Center ( Site 0068) — Los Angeles, California, United States (enrolling)
• UCLA Hematology/Oncology - Santa Monica ( Site 0002) — Los Angeles, California, United States (enrolling)
• University of California, Irvine (UCI) Health - UC Irvine Medical Center ( Site 0006) — Orange, California, United States (enrolling)
• Stanford Cancer Center ( Site 0046) — Palo Alto, California, United States (enrolling)
• Rocky Mountain Regional Veterans Affairs Medical Center ( Site 0053) — Aurora, Colorado, United States (enrolling)
• Yale-New Haven Hospital-Yale Cancer Center ( Site 0050) — New Haven, Connecticut, United States (enrolling)
• Veterans Affairs Connecticut Healthcare System ( Site 0062) — West Haven, Connecticut, United States (enrolling)
• The GW Medical Faculty Associates ( Site 0057) — Washington D.C., District of Columbia, United States (enrolling)
• Washington DC Veterans Affairs Medical Center ( Site 0056) — Washington D.C., District of Columbia, United States (enrolling)
• Mayo Clinic in Florida-Mayo Clinic Comprehensive Cancer Center ( Site 0077) — Jacksonville, Florida, United States (enrolling)
• Emory University School of Medicine- Grady Campus ( Site 0103) — Atlanta, Georgia, United States (enrolling)
• Winship Cancer Institute, Emory University ( Site 0003) — Atlanta, Georgia, United States (enrolling)
• Rush University Medical Center-Hematology and Oncology ( Site 0028) — Chicago, Illinois, United States (enrolling)
• University of Illinois at Chicago-University of Illinois Cancer Center ( Site 0063) — Chicago, Illinois, United States (enrolling)
• University of Kentucky Chandler Medical Center ( Site 0048) — Lexington, Kentucky, United States (enrolling)
• Greenebaum Comprehensive Cancer Center ( Site 0021) — Baltimore, Maryland, United States (enrolling)
• Beth Israel Deaconess Medical Center ( Site 0043) — Boston, Massachusetts, United States (enrolling)
• Dana Farber Cancer Institute ( Site 0012) — Boston, Massachusetts, United States (enrolling)
• University of Michigan ( Site 0005) — Ann Arbor, Michigan, United States (enrolling)
• Henry Ford Hospital ( Site 0035) — Detroit, Michigan, United States (enrolling)
• Mayo Clinic in Arizona - Phoenix ( Site 0044) — Phoenix, Arizona, United States (enrolling)

Full record on ClinicalTrials.gov

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