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

Clinicaltrials.gov ID: NCT06925737

Status RECRUITING

Phase PHASE3

Age ≥ 18 Years

Enrollments 1440

Conditions

Prostate Cancer, Prostatic Neoplasms

Drugs

Ifinatamab deruxtecan, Docetaxel, Prednisone

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,

Locations

8 locations Found with status Recruiting

Status

RECRUITING

Contact Person

Study Coordinator
616-399-6500

Study Director

Medical Director

Status

RECRUITING

Contact Person

Study Coordinator
612-341-4800

Study Director

Medical Director

Status

RECRUITING

Contact Person

Study Coordinator
612-341-4800

Study Director

Medical Director

Status

RECRUITING

Contact Person

Study Coordinator
406-238-6290

Study Director

Medical Director

Status

RECRUITING

Contact Person

Study Coordinator
402-334-4773

Study Director

Medical Director

Status

RECRUITING

Contact Person

Study Coordinator
402-334-4773

Study Director

Medical Director

Status

RECRUITING

Contact Person

Study Coordinator
551-996-5900

Study Director

Medical Director

Status

RECRUITING

Contact Person

Study Coordinator
540-982-0237

Study Director

Medical Director

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