A Clinical Study of Ifinatamab Deruxtecan (I-DXd) in People With Metastatic Prostate Cancer (MK-2400-001)
A Clinical Study of Ifinatamab Deruxtecan (I-DXd) in People With Metastatic Prostate Cancer (MK-2400-001)
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.
Prostate
Phase III
Adults
Chemotherapy - cytotoxic,
Mol. targeted/Immunotherapy/Biologics
Docetaxel (Taxotere),
Ifinatamab Deruxtecan,
Prednisone
Schaffer, Kerry
International
Vanderbilt University
05-13-2026
Eligibility
18 Years and older
MALE
false
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
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
