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RecruitingPHASE1, PHASE2INTERVENTIONAL

A Trial to Learn How Safe AZD9750 is and How Well it Works in People With Metastatic Prostate Cancer When Given With or Without Other Anticancer Drugs

This study, called ANDROMEDA, is testing a new medicine, AZD9750, for men with prostate cancer that has spread to other parts of the body. It’s what we call a 'first-in-human' study, meaning it’s one of the first times this medicine is being given to people. We want to find out how safe the medicine is at different doses, and how well your body handles it. We'll also be looking to see if it helps to slow down or shrink the cancer when given on its own, and when given together with another cancer medicine called saruparib. The study is split into two main parts, first looking at safety and then expanding to see how well it works.

At a glance

Status
Recruiting
Phase
PHASE1, PHASE2
Sponsor
AstraZeneca
Enrolment target
300
Start
27 Jan 2026
Estimated completion
26 Jan 2029

What is this study about?

This study is called ANDROMEDA, and it's designed to learn more about a new potential medicine, AZD9750, for men whose prostate cancer has spread to other parts of the body (this is called metastatic prostate cancer). When cancer spreads, it can be harder to treat, so researchers are always looking for new options.

The main goals of this study are to understand how safe AZD9750 is and how your body reacts to it. Researchers will also be looking to see if this medicine can help treat the cancer. They will test AZD9750 on its own, and also in combination with another cancer medicine called saruparib. The study has different stages to carefully check the safety and how well it works before moving on to larger groups of people. Future stages might also test AZD9750 with other cancer medicines.

Taking part in a study like this helps doctors learn more about new medicines and treatments. This knowledge is then used to help improve care for people with cancer in the future. The study will continue until the cancer gets worse, if the medicine causes side effects that are too uncomfortable, if you decide you no longer want to participate, or for other medical reasons.

Key takeaways

  • The study is testing a new medicine (AZD9750) for advanced prostate cancer.
  • It aims to understand the medicine's safety and how well it works.
  • Researchers will test it alone and with another drug (saruparib).
  • It's a 'first-in-human' study, meaning the medicine is new to people.
  • Participation involves regular medical check-ups and scans.
  • You can stop participating at any time.

Who may be eligible?

To join this study, you need to be at least 18 years old and have prostate cancer that has been confirmed by tests and has spread to other parts of your body. Also, your current prostate cancer must have shown signs of getting worse, for example, your PSA levels are rising, or scans show that the cancer has grown.

You would also need to be generally in good health, with certain blood and organ tests coming back within healthy ranges. Importantly, you would need to have had specific previous treatments for your prostate cancer, such as certain hormone therapies and possibly chemotherapy, depending on which part of the study you might join.

However, some things would mean you can't join. For example, if your cancer has spread to your brain or spinal cord, or if you have certain other serious medical conditions, especially heart problems. You also cannot have a type of prostate cancer that is mainly small cell or neuroendocrine carcinoma.

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 18 years old or older?
  2. Do you have prostate cancer that has spread to other parts of your body?
  3. Has your cancer recently shown signs of getting worse (e.g., rising PSA or new growth on scans)?
  4. Have you had specific prostate cancer treatments before (e.g., certain hormone therapies, possibly chemotherapy)?
  5. Are you generally feeling well with no major heart problems or spinal cord issues?
  6. Do you not have cancer in your brain?
Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll visit the study centre regularly. At these visits, doctors will monitor your health, check for any side effects, and see how the medicine is affecting your cancer. This will involve physical examinations, blood tests, pee tests, and scans (like bone scans or CT scans) to check your cancer. You will receive the study medicine (AZD9750, possibly with saruparib). The full duration of your participation could vary, as you will continue with the study treatment until your cancer gets worse, you experience side effects that are too uncomfortable, or you choose to stop.

Potential risks and benefits

Participating in this study might offer some potential benefits, such as gaining access to a new medicine before it's widely available, and your health will be closely monitored by medical experts. However, there are also potential risks, as new medicines can have side effects that are not yet fully known. These side effects could be mild or serious. All risks and benefits will be explained thoroughly by the study team. Remember, you can choose to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (18)

  • Research Site
    Verified postcode
    Duarte, United States· Recruiting
  • Research Site
    Verified postcode
    San Francisco, United States· Not yet recruiting
  • Research Site
    Verified postcode
    Tampa, United States· Not yet recruiting
  • Research Site
    Verified postcode
    Boston, United States· Not yet recruiting
  • Research Site
    Verified postcode
    St Louis, United States· Not yet recruiting
  • Research Site
    Verified postcode
    Myrtle Beach, United States· Recruiting
  • Research Site
    Verified postcode
    Nashville, United States· Recruiting
  • Research Site
    Verified postcode
    Salt Lake City, United States· Not yet recruiting
  • Research Site
    Verified postcode
    Melbourne, Australia· Recruiting
  • Research Site
    Verified postcode
    Calgary, Canada· Not yet recruiting
  • Research Site
    Verified postcode
    Vancouver, Canada· Not yet recruiting
  • Research Site
    Verified postcode
    Chengdu, China· Not yet recruiting

Common questions

What is 'metastatic prostate cancer'?

This means your prostate cancer has spread from your prostate to other parts of your body, like your bones.

What does 'first-in-human' mean?

It means this is one of the first times this new medicine is being tested in people. This helps us learn about its safety and effects before giving it to more patients.

Will I definitely get the new medicine?

Yes, in this study, everyone receives the new medicine, either on its own or in combination with another cancer drug.

How long will I be in the study?

You will continue to receive the study treatment as long as it is helping you and you are not experiencing uncomfortable side effects. This means the duration can vary for each person.

What if I change my mind after joining?

You have the right to withdraw from the study at any time, for any reason, without any impact on your future medical care.

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 "A Trial to Learn How Safe AZD9750 is and How Well it Works i…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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