Ifinatamab Deruxtecan Versus Docetaxel in Metastatic Castration-Resistant Prostate Cancer

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.


Eligibility

  • * 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
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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

Posadas, Edwin

Co-Investigators

David Hoffman, Jeremy Lorber, Jun Gong, Kevin Scher, Robert Figlin

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