Ifinatamab Deruxtecan Versus Docetaxel in Metastatic Castration-Resistant Prostate Cancer

Purpose of Study

What is the Purpose of this Study?

The purpose of this study is to evaluate the safety and effectiveness of an experimental drug called ifinatamab deruxtecan (I-DXd) in treating people with metastatic castration-resistant prostate cancer (mCRPC), as compared to the standard-of-care treatment, docetaxel. The study focuses on adults who have mCRPC that has worsened after previous treatment. Researchers will also evaluate whether participants who receive I-DXd experience longer periods of time before their pain increases, compared to participants who receive docetaxel. I-DXd is an antibody drug conjugate. The goal of an antibody drug conjugate is for the antibody to bind to a tumor cell, allowing the anticancer drug to enter directly. This targeted delivery of an anticancer drug to the tumor is expected to reduce the side effects when compared to a non targeted anticancer drug. Study procedures include physical exam, imaging scans, blood and urine sample collection, tumor biopsies and drug administration. Participants will be randomly assigned to 1 of 2 groups. One group will receive I-DXd, and the other will receive docetaxel and prednisone/prednisolone. Docetaxel is the standard-of-care drug for mCRPC. Prednisone/prednisolone is a steroid that may help prevent or reduce the side effects of docetaxel.


Study Eligibility

Eligibility


  • * Has histologically- or cytologically-confirmed adenocarcinoma of the prostate without small cell histology
  • * Has prostate cancer progression while on androgen deprivation therapy (ADT) (or post bilateral orchiectomy) within 6 months prior to Screening
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Study Sites

Where can I participate?



  • CS Cancer at Beverly Hills : Maria Tarallo
  • CS Cancer at Cedars-Sinai Medical Center : Maria Tarallo


More about this Clinical Trial

What is the full name of this clinical trial?

MK-2400-001: A Phase 3, Open-label Study of Ifinatamab Deruxtecan Versus Docetaxel in Participants with Metastatic Castration-Resistant Prostate Cancer

Study Details
Disease Type/Condition

Prostate

Principal Investigator
1

Posadas, Edwin

Co-Investigators

David Hoffman, Jeremy Lorber, Jun Gong, Kevin Scher

Age Group

Adult

Phase

III

IRB Number

STUDY00004085

ClinicalTrials.gov ID

NCT06925737

Key Eligibility
ClinicalTrials.gov

How do I learn more about this study?

Name

Maria Tarallo

Email

Maria.Tarallo@cshs.org
Study Detail
Disease Type/Condition

Prostate

Principal Investigator

Posadas, Edwin

Age Group

Adult

Phase

III

IRB Number

MK-2400-001

ClinicalTrials.gov ID

NCT06925737

Key Eligibility
ClinicalTrials.gov

Contact
Name

Maria Tarallo

Email
Maria.Tarallo@cshs.org