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

RECRUITINGPhase 3Sponsored by Merck Sharp & Dohme LLC
Actively Recruiting
PhasePhase 3
SponsorMerck Sharp & Dohme LLC
Started2025-05-13
Est. completion2028-06-26
Eligibility
Age18 Years+
SexMALE
Healthy vol.Accepted
Locations46 sites
View on ClinicalTrials.gov →

NCT06925737

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-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

Age: 18 Years+Sex: MALEHealthy volunteers accepted
Inclusion Criteria:

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 Criteria:

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

Conditions3

CancerProstate CancerProstatic Neoplasms

Locations46 sites

Mayo Clinic in Arizona - Phoenix ( Site 0044)
Phoenix, Arizona, 85054
Study Coordinator855-776-0015
City of Hope Comprehensive Cancer Center ( Site 0049)
Duarte, California, 91010
Study Coordinator626-256-4673
City of Hope Lennar Foundation Cancer Center ( Site 0059)
Irvine, California, 92618
Study Coordinator626-256-4673
Moores Cancer Center ( Site 0010)
La Jolla, California, 92093
Study Coordinator858-822-6100
Cedars-Sinai Medical Center ( Site 0068)
Los Angeles, California, 90048
Study Coordinator310-423-7600

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