Study

Overview

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

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,

Study Type:

Interventional

Study Phase:

Phase 3

Estimated Enrollment:

1440

Study Start Date:

May 2025

Estimated Study Completion Date:

January 2031

Estimated Primary Completion Date:

June 2028

Eligibility

Ages Eligible for Study:

18 years and older

Genders Eligible for Study:

Male

Accepts Healthy Volunteers:

No

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

United States Toll Free Number 1-800-770-4674

duarte, California, 91010
Irvine, California, 92618
La Jolla, California, 92093
Atlanta, Georgia, 30303
Atlanta, Georgia, 30322
Grand Rapids, Michigan, 49503
Saint Paul, Minnesota, 55101
St. Louis Park, Minnesota, 55426
Billings, Montana, 59102
Grand Island, Nebraska, 68803
Omaha, Nebraska, 68130
Hackensack, New Jersey, 07601
Dallas, Texas, 75390
Roanoke, Virginia, 24014

Results

Click here to access ClinicalTrials.gov site to view results.

Study Detail

A clinical study of ifinatamab deruxtecan (I-DXd) in people with metastatic prostate cancer (MK-2400-001)

Overview

Eligibility

CRITERIA

Locations

Results