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RecruitingPHASE1, PHASE2INTERVENTIONAL

Study of AZD0516 as Monotherapy and in Combination in Participants With Metastatic Prostate Cancer

This research study is looking at a new medicine called AZD0516 for men who have prostate cancer that has spread to other parts of the body (metastatic prostate cancer). The main goal is to understand if AZD0516 is safe and how well people tolerate it. Researchers will test it by itself and also in combination with another experimental drug, AZD9574. This first-of-its-kind study will involve different groups of patients, carefully increasing the dose to find the most effective and safest amount. It's an important step in finding new ways to treat advanced prostate cancer.

At a glance

Status
Recruiting
Phase
PHASE1, PHASE2
Sponsor
AstraZeneca
Enrolment target
177
Start
01 Oct 2025
Estimated completion
18 Jan 2029

What is this study about?

This study is about exploring a new potential treatment for men living with prostate cancer that has spread beyond the prostate gland, known as metastatic prostate cancer. The new medicine is called AZD0516. The main aim of this research is to see if AZD0516 is safe for people to take and to understand any side effects it might cause. Researchers will also be looking to see if it shows any signs of helping to fight the cancer.

The study will involve two main approaches. In one part, male participants will receive AZD0516 by itself. In another part, AZD0516 will be given alongside another experimental drug called AZD9574. The study is designed to carefully test different amounts of the drug to find the safest and most effective dose. This type of early-stage research is crucial for developing new medicines that could improve the lives of people with cancer.

This is a 'first-in-human' study, meaning it's one of the first times this medicine is being tested in people. It's a multi-centre study, so it will involve several hospitals or clinics. The information gathered from this study about safety, how the body handles the drug, and any anti-cancer effects will be very important for deciding if these treatments should be studied further in larger trials.

Key takeaways

  • This study is testing a new drug (AZD0516) for advanced prostate cancer.
  • It's an early-stage study focused on safety and initial effectiveness.
  • The drug will be tested alone and with another experimental drug (AZD9574).
  • Participation requires regular clinic visits, blood tests, and scans.
  • You must have metastatic prostate cancer that is currently progressing.
  • You can withdraw from the study at any time without affecting your care.

Who may be eligible?

To join this study, you must be a man aged 18 or older with prostate cancer that has spread and has been confirmed by a doctor. Your cancer must also be responding to hormone therapy (meaning your testosterone levels are low due to treatment or surgery).

Doctors will also check your overall health using a scale called ECOG, and you'll need to be quite well to take part. Your body's organs, like your liver and kidneys, need to be working properly, and your blood counts should be healthy. You must also have evidence that your cancer has recently gotten worse, which can be seen by increases in your PSA blood test, new growths on scans, or new spots on bone scans.

There are also reasons why you might not be able to join. For example, if your cancer has spread to your brain or is pressing on your spinal cord, unless these issues are stable and don't require high doses of certain medications, you probably won't be eligible. The study team will review all your medical information carefully to see if this study is right for you.

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. Are you a man, 18 years or older?
  2. Do you have prostate cancer that has spread?
  3. Are your testosterone levels low due to treatment or surgery?
  4. Has your cancer shown signs of getting worse recently?
  5. Is your general health good enough for you to be active?
  6. Can you provide a small sample of your tumor tissue?
Answer every question to see your result.

What does participation involve?

If you join this study, you'll receive the study medicine, AZD0516 (either alone or with another drug, AZD9574), according to a plan set by the study team. You will have regular visits to the clinic for check-ups, blood tests, and scans to see how you are doing and how the medicine is affecting your body and the cancer. These visits will also help the doctors track any side effects. You'll continue to receive your standard hormone therapy (if you haven't had surgery to remove your testes) throughout the study. The total duration of your participation will depend on how you respond to the treatment and what the study doctors decide, but it will involve ongoing assessments and potentially follow-up after the treatment phase ends.

Potential risks and benefits

Participating in this study might offer a potential benefit if the new drug helps control your cancer, but this is not guaranteed as it's an early-stage trial. The main purpose is to learn more about the drug. Like with any medicine, there are potential risks and side effects that the study doctors will discuss in detail. Your safety is the top priority, and you'll be closely monitored throughout the study. Remember, joining a study is always voluntary, and you have the right to withdraw at any time, for any reason, without it affecting your future medical care.

Locations (52)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • Research Site
    Verified postcode
    Fayetteville, United States· Recruiting
  • Research Site
    Verified postcode
    Los Angeles, United States· Recruiting
  • Research Site
    Verified postcode
    Towson, United States· Suspended
  • Research Site
    Verified postcode
    Boston, United States· Recruiting
  • Research Site
    Verified postcode
    Ann Arbor, United States· Recruiting
  • Research Site
    Verified postcode
    Detroit, United States· Recruiting
  • Research Site
    Verified postcode
    Buffalo, United States· Suspended
  • Research Site
    Verified postcode
    New York, United States· Recruiting
  • Research Site
    Verified postcode
    Providence, United States· Recruiting
  • Research Site
    Verified postcode
    Myrtle Beach, United States· Recruiting
  • Research Site
    Verified postcode
    Houston, United States· Recruiting
  • Research Site
    Verified postcode
    Barretos, Brazil· Not yet recruiting

Common questions

What is metastatic prostate cancer?

This is prostate cancer that has spread from the prostate gland to other parts of the body, such as bones or other organs.

What is a 'first-in-human' study?

It means this is one of the first times this new medicine is being given to people, so researchers are learning about its safety and effects for the very first time.

Will I know if I'm getting the active drug?

Yes, in this study, all participants will receive the study medication (AZD0516, either alone or with AZD9574). There is no placebo group.

What does 'monotherapy' and 'combination therapy' mean?

'Monotherapy' means you'd receive only the AZD0516 drug. 'Combination therapy' means you'd receive AZD0516 along with another drug, AZD9574.

How long will I be in the study?

The length of your participation will depend on how you respond to the treatment and the study plan, but it involves ongoing visits and checks. Your study doctor can give you more specific details.

How to find out more

AstraZeneca Clinical Study Information Center

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 "Study of AZD0516 as Monotherapy and in Combination in Partic…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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