A Clinical Study of Ifinatamab Deruxtecan (I-DXd) in People With Metastatic Prostate Cancer (MK-2400-001)
Sponsor: Merck Sharp & Dohme LLC
ClinicalTrials ID:NCT06925737
This study evaluates ifinatamab deruxtecan (I-DXd) for treating mCRPC. Eligible participants have mCRPC with progression on ADT and prior ARPI treatment. Interventions include I-DXd and standard chemotherapy (docetaxel with prednisone). I-DXd and docetaxel are administered via IV every 3 weeks, while prednisone is taken orally daily.
Patient Parameters
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Program Overview
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 Criteria
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
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Cancer and Hematology Centers of Western Michigan ( Site 0015) | 49503 | Grand Rapids | Michigan |
| St. Vincent Frontier Cancer Center-Research ( Site 0037) | 59102 | Billings | Montana |
| Blue Ridge Cancer Care ( Site 0024) | 24014 | Roanoke | Virginia |
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