Substudy of I-DXd-based Treatment Combinations or Monotherapy in mCRPC

• Research type

  Research Study

• Full title

  MK-2400-01A Substudy: A Phase 1/2, Open-label Umbrella Substudy of MK-2400-U01 Master Protocol to Evaluate the Safety and Efficacy of Ifinatamab Deruxtecan-based Treatment Combinations or Ifinatamab Deruxtecan Alone in Participants With Metastatic Castration-resistant Prostate Cancer (mCRPC) (IDeate-Prostate02)

• IRAS ID

  1011398

• Contact name

  - -

• Contact email

  N/A

• Sponsor organisation

  Merck Sharp & Dohme LLC

• Clinicaltrials.gov Identifier

  NCT06863272

• Research summary

  Researchers are looking for new ways to treat metastatic castration-resistant prostate cancer (mCRPC). Usual treatments for mCRPC include additional hormone therapy and chemotherapy.

  Researchers want to learn if ifinatamab deruxtecan (I-DXd), trial treatment, given alone or with other treatments can treat mCRPC. I-DXd is an antibody drug conjugate (ADC) that attaches to a protein on cancer cells and delivers treatment to destroy those cells.

  Up to 360 participants aged 18 years and older with mCRPC will be in this trial for up to 2 years. The participants in the trial and the researcher will know which treatment they receive.

  Researchers will assign participants to 1 of 4 treatment groups:
  A - Chemotherapy
  B - I-DXd
  C - I-DXd & MK-5684 - treatment that blocks the body from making steroid hormones. Researchers will give MK 5684 with supportive adrenal therapy (SAT).
  D - I-DXd plus abiraterone acetate or enzalutamide - anti-hormone therapy that blocks or lowers hormones that can help cancer grow.

  This trial has 2 Parts:
  Part 1:
  Participants in Groups C & D will get a low dose of I-DXd with a fixed dose of the other treatment.
  Researchers will check for safety concerns before giving a higher dose of I-DXd.
  Researchers will then choose a safe dose of I-DXd that can be used with the other treatments and give this dose to Groups C & D in Part 2.

  Part 2:
  Group A will receive a fixed dose of chemotherapy.
  Group B will receive a fixed dose of I-DXd.
  Groups C & D will receive the dose of I-DXd chosen in Part 1 with a fixed dose of the other treatment. Participants will receive chemotherapy for up to 8 months and all other treatments until the cancer gets worse, they stop treatment, or do not tolerate it.

• REC name

  London - London Bridge Research Ethics Committee

• REC reference

  25/LO/0192

• Date of REC Opinion

  21 May 2025

• REC opinion

  Further Information Favourable Opinion