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

RecruitingPhase 3

Sponsor: Merck Sharp & Dohme LLC

Conditions: Prostate Cancer, Prostatic Neoplasms

Interventions: Ifinatamab deruxtecan, Docetaxel, Prednisone, Rescue Medication

Countries: United States, Argentina, Australia, Austria, Brazil, Chile, China, Colombia

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 overview

Sex: MALE

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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

Locations (294)

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
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
Washington D.C., District of Columbia, United States
Jacksonville, Florida, United States
Atlanta, Georgia, United States
Atlanta, Georgia, United States
Chicago, Illinois, United States
Chicago, Illinois, United States
Lexington, Kentucky, United States
Baltimore, Maryland, United States
Boston, Massachusetts, United States
Boston, Massachusetts, United States
Ann Arbor, Michigan, United States
Detroit, Michigan, United States
Grand Rapids, Michigan, United States
Rochester, Minnesota, United States
Saint Louis Park, Minnesota, United States
Saint Paul, Minnesota, United States
Billings, Montana, United States
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