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

ID#: NCT06925737

Age: 18 years - 66+

Gender: Male

Healthy Subjects: No

Study Phase: Phase 3

Recruitment Status: Recruiting

Start Date: May 13, 2025

End Date: January 06, 2031

Contact Information:
Toll Free Number
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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
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