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RecruitingPHASE1, PHASE2INTERVENTIONAL

A Clinical Study of Ifinatamab Deruxtecan Based Treatment Combinations or as Monotherapy to Treat Metastatic Castrate Resistant Prostate Cancer (mCRPC) (MK-2400-01A/IDeate-Prostate02)

This research study is looking into new ways to treat advanced prostate cancer that has spread to other parts of the body (metastatic) and is no longer controlled by hormone therapy. It's called "castrate-resistant" prostate cancer. The main aim is to understand how safe a new drug called ifinatamab deruxtecan (I-DXd) is, both on its own and when given with other established treatments. We also want to find the right dose of I-DXd to use with other drugs and see how it affects a blood marker for prostate cancer called PSA. This study is in its early stages (Phase 1 and 2), meaning it's still investigating the drug's safety and initial effectiveness.

At a glance

Status
Recruiting
Phase
PHASE1, PHASE2
Sponsor
Merck Sharp & Dohme LLC
Enrolment target
360
Start
03 Jul 2025
Estimated completion
01 Apr 2031

What is this study about?

This study, known by its full medical name as MK-2400-01A/IDeate-Prostate02, is designed for men living with advanced prostate cancer that has spread and has stopped responding to hormone therapy. Doctors call this "metastatic castration-resistant prostate cancer" or mCRPC. This can be a challenging form of cancer to treat, so researchers are always looking for new and better treatment options.

The main goal of this particular study is to explore a new treatment called ifinatamab deruxtecan (I-DXd). We want to understand how safe it is for patients, both when given by itself and when combined with other medicines that are already used to treat prostate cancer. Finding a safe dose of I-DXd that works well with other treatments is also a key objective. Additionally, the study will monitor how these treatments might affect levels of prostate-specific antigen (PSA) in the blood, which can be an indicator of how prostate cancer is behaving.

This is a 'Phase 1' and 'Phase 2' study. This means it's an early-stage trial. Phase 1 trials primarily focus on safety and finding the right dose, while Phase 2 trials begin to assess how effective the treatment is, usually in a larger group of patients. By carefully studying I-DXd, researchers hope to gather important information that could lead to new treatment choices for men with mCRPC in the future.

Key takeaways

  • This study is for advanced prostate cancer that no longer responds to hormone therapy.
  • It's testing a new drug called ifinatamab deruxtecan (I-DXd) alone or with other treatments.
  • The main goals are to check safety, find the best dose, and see how it affects PSA levels.
  • Participation involves regular clinic visits, blood tests, and scans.
  • You might get access to a new treatment, but there are potential side effects.
  • You can withdraw from the study at any time.

Who may be eligible?

To join this study, participants generally need to have a confirmed diagnosis of prostate cancer that started in the glands and has evidence of spreading to other parts of the body. Their cancer must have progressed despite hormone treatment, and they should have already received at least one or two specific types of hormone-blocking medicines. They also need to be able to carry out their daily activities quite well, as measured by a doctor.

There are also some reasons why someone might not be able to join. For instance, if you have certain lung conditions, like a history of serious lung inflammation, or have uncontrolled heart disease or uncontrolled diabetes, you likely wouldn't be eligible. Men who have recently undergone certain chemotherapy treatments or radiotherapy might also be excluded for safety reasons.

It's important to remember that these are just some of the main points. A full assessment by the study doctors will be needed to determine if someone is a good fit for the trial, considering all aspects of their health.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

  1. Do you have confirmed prostate cancer that has spread?
  2. Has your prostate cancer gotten worse despite hormone treatment?
  3. Have you already used at least one or two specific hormone-blocking drugs?
  4. Are you able to manage your daily activities without much difficulty?
  5. Do you have any serious lung conditions or uncontrolled heart disease?
Answer every question to see your result.

What does participation involve?

If you are eligible and choose to take part in this study, you would receive the study treatment, which could be ifinatamab deruxtecan (I-DXd) alone or in combination with other established medicines. The frequency of your visits to the clinic would depend on the specific treatment plan, but typically involves regular check-ups, blood tests (including PSA levels), and other assessments to monitor your health and how the treatment is working. This helps the researchers understand the effects of the treatment and manage any side effects. You might also have scans to check your cancer. The total duration of participation in the study, including follow-up after treatment, would be discussed in detail by the study team.

Potential risks and benefits

Taking part in a clinical trial offers the potential benefit of accessing new treatments before they are widely available. While the specific benefits cannot be guaranteed, patients might experience an improvement in their condition or a slowed progression of their cancer. However, like all medicines, the study treatments may cause side effects, and some could be serious. Researchers will closely monitor your health to identify and manage any potential risks. It's crucial to remember that participation is entirely voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your future medical care.

Locations (80)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • UCLA Hematology & Oncology ( Site 0003)
    Verified postcode
    Los Angeles, United States· Recruiting
  • University of California-Irvine Medical Center ( Site 0016)
    Verified postcode
    Orange, United States· Recruiting
  • UCSF Medical Center at Mission Bay ( Site 0034)
    Verified postcode
    San Francisco, United States· Recruiting
  • MedStar Georgetown Cancer Institute at MedStar Washington Hospital Center ( Site 0026)
    Verified postcode
    Washington D.C., United States· Recruiting
  • Memorial Sloan Kettering Cancer Center ( Site 0006)
    Verified postcode
    New York, United States· Recruiting
  • UPMC Hillman Cancer Center ( Site 0014)
    Verified postcode
    Pittsburgh, United States· Recruiting
  • The West Clinic, PLLC dba West Cancer Center ( Site 0005)
    Verified postcode
    Germantown, United States· Recruiting
  • Fred Hutchinson Cancer Center ( Site 0013)
    Verified postcode
    Seattle, United States· Recruiting
  • Instituto Alexander Fleming ( Site 0202)
    Unverified
    Ciudad Autónoma de Buenos Aires, Argentina· Recruiting
  • Fundación CORI para la Investigación y Prevención del Cáncer ( Site 0200)
    Verified postcode
    La Rioja, Argentina· Recruiting
  • Macquarie University-MQ Health Clinical Trials Unit ( Site 0801)
    Unverified
    Macquarie University, Australia· Recruiting
  • Liga Norte Riograndense Contra o Câncer ( Site 0271)
    Verified postcode
    Natal, Brazil· Recruiting

Common questions

What is 'castration-resistant prostate cancer'?

This is prostate cancer that continues to grow and spread even after hormone therapy that lowers male hormone levels.

What is ifinatamab deruxtecan (I-DXd)?

It's a new experimental drug being investigated to treat advanced prostate cancer. This study is testing its safety and effectiveness.

What does 'metastatic' mean?

It means the cancer has spread from the prostate to other parts of the body.

Will I receive the new drug alone or with other treatments?

The study is testing ifinatamab deruxtecan both on its own and in combination with other standard prostate cancer treatments.

How long will the study last if I join?

The exact duration for each participant will vary and will be explained by the study team, including treatment and follow-up periods.

How to find out more

Toll Free Number

Always speak to your GP or specialist before deciding to take part in a study.

Interested in taking part?

Register your interest

Share your details and the research team for "A Clinical Study of Ifinatamab Deruxtecan Based Treatment Co…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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