Phase 3 Study of I-DXd Versus Docetaxel in mCRPC

• Research type

  Research Study

• Full title

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

• IRAS ID

  1011567

• Contact name

  - -

• Contact email

  N/A

• Sponsor organisation

  Merck Sharp & Dohme LLC

• Research summary

  Researchers are looking for new ways to treat metastatic castration-resistant prostate cancer (mCRPC). Researchers designed a study medicine called ifinatamab deruxtecan (also called I-DXd or MK-2400) to treat mCRPC. I-DXd is an antibody drug conjugate (ADC). An ADC attaches to a protein on cancer cells and delivers treatment to destroy those cells.
  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.
  Up to about 1,440 people (assigned male sex at birth) with mCRPC will be in this study. They will meet certain criteria to be in this study. For example, they will be 18 years and older and:
  • Had their cancer get worse after receiving treatment with 1 or 2 androgen receptor pathway inhibitors (ARPIs). ARPIs are medicines that stop hormones from causing cancer cells to grow.
  • Do not have certain lung or heart problems
  People will be assigned to receive 1 of these treatments given into a vein as an intravenous (IV) infusion every 3 weeks:
  • I-DXd, the study medicine
  • Docetaxel, chemotherapy
  People will receive I-DXd until their cancer grows or spreads, they do not tolerate it, or until they or the researcher decides to stop it. People will receive docetaxel for about 7 months.
  Researchers will randomly assign people by equal chance to receive either I-DXd or docetaxel. Both the people in the study and the researchers will know which study treatment a person is getting (open-label study).
  During the study, people will give blood, urine, and tissue samples. They will also have physical and eye examinations, tests to check their heart, tumour and imaging tests, and answer questions about how they are feeling. People may be in this study for up to about 2 years.

• REC name

  East Midlands - Nottingham 2 Research Ethics Committee

• REC reference

  25/EM/0094

• Date of REC Opinion

  27 Jun 2025

• REC opinion

  Further Information Favourable Opinion