Status:
RECRUITING
A Clinical Study of Ifinatamab Deruxtecan (I-DXd) in People With Metastatic Prostate Cancer (MK-2400-001)
Lead Sponsor:
Merck Sharp & Dohme LLC
Collaborating Sponsors:
Daiichi Sankyo
Conditions:
Prostate Cancer
Prostatic Neoplasms
Eligibility:
MALE
18+ years
Phase:
PHASE3
Brief 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-...
Eligibility Criteria
Inclusion
- The main inclusion criteria include but are not limited to the following:
- Has diagnosis of metastatic castration-resistant prostate cancer (mCRPC)
- Has prostate cancer progression while on androgen deprivation therapy (ADT) (or post bilateral orchiectomy) within 6 months prior to entering the study
- Has received prior treatment with 1 or 2 androgen receptor pathway inhibitor (ARPI) and progressed during or after at least 8 weeks of treatment
Exclusion
- The main exclusion criteria include but are not limited to the following:
- History of (non-infectious) interstitial lung disease (ILD)/pneumonitis that required steroids
- Has uncontrolled or significant cardiovascular disease
- Has received prior treatment with a taxane-based chemotherapy agent for mCRPC
Key Trial Info
Start Date :
May 13 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 6 2031
Estimated Enrollment :
1440 Patients enrolled
Trial Details
Trial ID
NCT06925737
Start Date
May 13 2025
End Date
January 6 2031
Last Update
January 9 2026
Active Locations (250)
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1
Mayo Clinic in Arizona - Phoenix ( Site 0044)
Phoenix, Arizona, United States, 85054
2
City of Hope Comprehensive Cancer Center ( Site 0049)
Duarte, California, United States, 91010
3
City of Hope Lennar Foundation Cancer Center ( Site 0059)
Irvine, California, United States, 92618
4
Moores Cancer Center ( Site 0010)
La Jolla, California, United States, 92093