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Study of ifinatamab deruxtecan alone or in combination with other treatments for patients with metastatic castration-resistant prostate cancer

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial studies the treatment of metastatic castration-resistant prostate cancer using ifinatamab deruxtecan, either alone or in combination with other medications. The study aims to evaluate whether this treatment is safe and effective for patients whose cancer has continued to progress despite previous hormone therapy treatments.

The main treatment being tested is ifinatamab deruxtecan, which is given through an intravenous infusion. Some patients may also receive other medications including docetaxel, abiraterone, or enzalutamide. The study will monitor how well patients respond to treatment by measuring changes in tumor size and levels of a protein called prostate-specific antigen in the blood.

During the study, doctors will track patients' progress by performing regular medical examinations and tests. They will monitor for side effects and measure how well the treatment works in controlling cancer growth. The study will also look at how long patients live without their cancer getting worse and their overall survival time.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial evaluation and assignment

    Your eligibility for the study will be confirmed based on having metastatic prostate cancer that has progressed while on hormone therapy within the last 6 months

    Your performance status will be evaluated using the ECOG scale (a measure of daily activity ability)

    Your medical history will be reviewed, including previous treatments with hormone therapy medications

  2. Step 2

    Treatment assignment

    You will be assigned to receive either ifinatamab deruxtecan alone or in combination with other medications

    If you are receiving bone treatments (such as bisphosphonates), these must remain stable for at least 4 weeks before starting the study

  3. Step 3

    Treatment administration

    Ifinatamab deruxtecan will be given through an intravenous infusion (into a vein)

    Additional oral medications may include: abiraterone, enzalutamide, prednisolone, or other specified treatments

    Regular monitoring of your PSA levels (prostate-specific antigen) will occur throughout the treatment

  4. Step 4

    Ongoing monitoring

    Your response to treatment will be evaluated through regular medical examinations

    Side effects will be monitored and documented throughout the study period

    Imaging scans will be performed to assess how the cancer responds to treatment

  5. Step 5

    Study completion

    The study is expected to continue until December 2029

    Your participation may end earlier based on your response to treatment or if side effects occur

    Final evaluations will be conducted to assess the overall effectiveness of the treatment

Who can join the trial?

8 criteria

  • Male patients aged 18 years and older
  • Must have confirmed prostate cancer (specifically adenocarcinoma type, without small cell features) through tissue or cell examination
  • Must have cancer that has spread to other parts of the body (metastatic disease)
  • Must show cancer progression while receiving hormone therapy (or after surgical removal of testicles) within 6 months before screening
  • Must have received and shown progression during or after treatment with 1 or 2 androgen receptor pathway inhibitors (medications that block male hormones)
  • If receiving bone strengthening treatments (such as bisphosphonates or denosumab), must be on stable doses for at least 4 weeks before study enrollment
  • Must have good physical function status (ECOG score of 0-1, meaning able to perform daily activities with minimal assistance) within 10 days before study enrollment
  • Must have previous treatment with PARP inhibitors (if recommended by local treatment guidelines) or be considered unsuitable for PARP inhibitor treatment by their doctor

Who cannot join the trial?

14 criteria

  • Male patients younger than 18 years old
  • Patients who have not been diagnosed with metastatic castrate resistant prostate cancer (mCRPC)
  • Female patients (study is designed for male participants only)
  • Patients who are unable to provide informed consent
  • Patients with history of allergic reactions to similar treatments
  • Patients currently participating in other clinical trials
  • Patients with severe liver or kidney dysfunction
  • Patients with uncontrolled or severe heart conditions
  • Patients with active infections requiring treatment
  • Patients with conditions that could interfere with the study procedures
  • Patients unable to follow study procedures or attend scheduled visits
  • Patients with history of another type of cancer in the past 5 years (except for adequately treated non-melanoma skin cancer)
  • Patients with untreated brain metastases (cancer spread to the brain)
  • Patients who cannot take oral medications
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Investigated drugs

Ifinatamab deruxtecan is an antibody-drug conjugate medication being studied for the treatment of metastatic castration-resistant prostate cancer. This medication works by targeting specific proteins found on cancer cells and delivering a cancer-fighting drug directly to these cells. It can be used either alone or in combination with other treatments to potentially help patients whose prostate cancer has spread and no longer responds to hormone therapy. Note: While the trial mentions treatment combinations, the specific combination medications are not detailed in the provided source data, so they cannot be listed separately.

What is already known about the treatment

Ifinatamab Deruxtecan - A novel antibody-drug conjugate administered through intravenous infusion, currently being investigated in clinical trials for the treatment of metastatic castration-resistant prostate cancer (mCRPC). This medication works by combining a targeted antibody that recognizes specific proteins on cancer cells with a potent chemotherapy drug, allowing for precise delivery of the cancer-fighting agent to tumor cells while minimizing damage to healthy tissue. As part of the emerging class of targeted cancer therapies, it represents a promising approach in oncology, particularly for patients whose cancer has progressed despite standard treatments. The drug is currently being evaluated in clinical trials to assess its safety profile and effectiveness, both as a standalone treatment and in combination with other anti-cancer medications.

Investigated diseases

Metastatic Castrate Resistant Prostate Cancer (mCRPC) - A progressive form of prostate cancer that continues to grow even when testosterone levels in the body are very low. In this condition, cancer cells have adapted to grow despite hormone therapy that reduces testosterone. The disease typically develops from earlier stages of prostate cancer, where cancer cells spread beyond the prostate to other parts of the body (metastasis). These cancer cells can establish new tumors in bones, lymph nodes, or other organs. The disease is characterized by rising levels of prostate-specific antigen (PSA) in blood tests and continued cancer growth despite low testosterone levels.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase ITrial ID2024-516036-94-00Protocol codeMK-2400-01AEstimated enrolment361 patientsSponsorMerck Sharp & Dohme LLC

sourced from the EU Clinical Trials Register and site verification

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