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:
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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 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

Exclusion Criteria: 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:

1. Has any history of ILD/pneumonitis that required steroid use, except for a history of radiation pneumonitis that did not require steroids

2. Has current ILD/pneumonitis

3. 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
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