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

Overview

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 Participate

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

Disclaimer

This summary is based on publicly available information from clinicaltrials.gov and is intended to help patients discuss possible trial options with their oncology care team. ClinicalTrials.gov and related public listings do not independently review or approve the safety and scientific merit of every study.

Participation decisions can be made only after review by the study team and your treating clinician.