NCT06925737

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

A Phase 3, Open-label Study of Ifinatamab Deruxtecan Versus Docetaxel in Participants With Metastatic Castration-Resistant Prostate Cancer (mCRPC) (IDeate-Prostate01)

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,440 (estimated)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Prostate Cancer
• Prostatic Neoplasms

Interventions

Type	Name	Description
DRUG	Ifinatamab deruxtecan	Administered via intravenous (IV) infusion every 3 weeks (q3w) until disease progression, unacceptable adverse events (AEs), or other cessation of treatment
DRUG	Docetaxel	Administered via IV infusion q3W until disease progression, unacceptable adverse events (AEs), or other cessation of treatment
DRUG	Prednisone	Oral tablet administered once per day or per approved product label
DRUG	Rescue Medication	Before administering each dose of I-DXd, premedication is required for prevention of nausea and vomiting with a 2 or 3 drug combination regimen (eg, corticosteroids with either a 5-HT3 receptor antagonist or an NK-1 receptor antagonist and other drugs as indicated) per approved product label

Timeline

• Start date: 2025-05-13
• Primary completion: 2028-06-26
• Completion: 2031-01-06
• First posted: 2025-04-13
• Last updated: 2026-04-13

Locations

279 sites across 34 countries: United States, Argentina, Australia, Austria, Brazil, Chile, China, Colombia, Czechia, Denmark, France, Germany, Greece, Guatemala, Hong Kong, Ireland, Israel, Italy, Japan, Malaysia, Mexico, Netherlands, Norway, Peru, Poland, Singapore, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey (Türkiye)

Regulatory

• FDA-regulated drug study