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New treatment option for Prostate Cancer
Official title A Clinical Study of Ifinatamab Deruxtecan (I-DXd) in People With Metastatic Prostate Cancer (MK-2400-001)
ClinicalTrials.gov ID: NCT06925737
What this study is testing
What is Ifinatamab deruxtecan?
Ifinatamab deruxtecan is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for prostate cancer.
Also referred to as I-DXd, MK-2400.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, men only
You may be able to join if
- The main 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...
- Has received prior treatment with 1 or 2 androgen receptor pathway inhibitors (ARPIs) and progressed during or after at least 8 weeks of treatment
You likely can't join 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
See the full eligibility criteria
- The main 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Phoenix, Arizona, United States
- Duarte, California, United States
- Irvine, California, United States
- La Jolla, California, United States
- Long Beach, California, United States
- Los Angeles, California, United States
- Orange, California, United States
- Palo Alto, California, United States
- Aurora, Colorado, United States
- New Haven, Connecticut, United States
- West Haven, Connecticut, United States
- Washington D.C., District of Columbia, United States
- Jacksonville, Florida, United States
- Atlanta, Georgia, United States
- Chicago, Illinois, United States
- Lexington, Kentucky, United States
- Baltimore, Maryland, United States
- Boston, Massachusetts, United States
- Ann Arbor, Michigan, United States
- Detroit, Michigan, United States
+ 227 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Phoenix, Arizona, United States; Duarte, California, United States; Irvine, California, United States; La Jolla, California, United States; Long Beach, California, United States; Los Angeles, California, United States and 241 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.