All studies
RecruitingPHASE1, PHASE2INTERVENTIONAL

A Study to Learn How Safe AZD6621 is, How Well it Works, and How it Moves Throughout the Body Over Time, in Adult Male Participants With Metastatic Prostate Cancer

This study is investigating a new experimental treatment called AZD6621 for adult men who have prostate cancer that has spread to other parts of the body (metastatic prostate cancer). The main goals are to understand how safe AZD6621 is, if it helps to treat the cancer, and how the body handles the drug over time. The study is split into stages: an early stage (Phase 1) to find the best and safest dose, and then a later stage (Phase 2) where more people will test that dose. Different ways of giving the treatment will also be explored.

At a glance

Status
Recruiting
Phase
PHASE1, PHASE2
Sponsor
AstraZeneca
Enrolment target
52
Start
30 Sep 2025
Estimated completion
29 Mar 2029

What is this study about?

Imagine your doctor tells you that your prostate cancer has spread to other parts of your body, and current treatments aren't working as well as hoped. This can be a worrying time. That's why researchers are constantly looking for new ways to fight cancer.

This study is focusing on a new potential medication called AZD6621. Think of it like a new key that researchers hope can unlock a better way to treat advanced prostate cancer. The main purpose of this study is to carefully investigate this new key: how safe is it for people to take, does it actually help against the cancer, and how does it behave once it's in the body? This information is really important for developing new treatments.

The study is happening in stages. Initially, a small group of participants will receive different doses of AZD6621 to find out which dose is the safest and causes the fewest side effects. This is a crucial step to make sure future participants are given a dose that is both effective and manageable. Once safe doses are identified, a larger group of participants will then try these specific doses to further understand how well the treatment works and to gather more information on its safety. Different ways of giving the treatment will also be tested.

Key takeaways

  • This study is testing a new drug called AZD6621 for men with advanced prostate cancer.
  • It aims to understand the safety, side effects, and effectiveness of this new treatment.
  • You must be an adult male with prostate cancer that has spread and worsened despite standard treatments.
  • Participation involves regular hospital visits for checks and scans.
  • You have the right to leave the study at any time.
  • This is an 'open-label' study, meaning you will know you are receiving the experimental drug.

Who may be eligible?

This study is looking for men who have prostate cancer that has spread to other parts of their body, even after some other treatments. Your cancer must be a specific type called 'adenocarcinoma' and you must be at least 18 years old.

Your testosterone levels need to be low, either because you've had an operation to remove your testicles or you're already taking medication that lowers testosterone. Importantly, your prostate cancer must have started growing again despite these treatments. We'll also need a recent sample of your tumour tissue, either a fresh one or one that was taken previously.

Doctors will also need to see that your cancer has actually progressed recently, either by looking at blood tests (like PSA levels) or by scans that show new or growing tumours. The specific treatments you've had before might also play a role in whether you can join, depending on which part of the study you might be considered for.

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 an adult male?
  2. Do you have prostate cancer that has spread to other parts of your body?
  3. Has your prostate cancer continued to grow despite treatments like hormone therapy, which lower testosterone?
  4. Are your testosterone levels currently low?
  5. Do you have a recent sample of your tumour tissue available?
  6. Have scans or blood tests shown your cancer has progressed recently?
Answer every question to see your result.

What does participation involve?

Taking part in this study means you'll receive the experimental drug AZD6621. You'll have regular hospital visits for check-ups, blood tests, and scans to see how you're responding to the treatment and to monitor for any side effects. These assessments will help the study team understand how the drug is working in your body and to keep you safe. The total length of your participation will depend on which part of the study you are in and how you respond to the treatment, but it will involve ongoing check-ups for a period of time.

Potential risks and benefits

While participating, there's a chance the experimental treatment AZD6621 might not help your cancer, or it could cause side effects. All study treatments carry potential risks, and these will be fully explained to you before you decide to take part. However, a potential benefit is that you might gain access to a new treatment that isn't widely available yet, which could help your condition. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (25)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • Research Site
    Verified postcode
    Orlando, United States· Not yet recruiting
  • Research Site
    Verified postcode
    Tampa, United States· Recruiting
  • Research Site
    Verified postcode
    Boston, United States· Withdrawn
  • Research Site
    Verified postcode
    Grand Rapids, United States· Recruiting
  • Research Site
    Verified postcode
    Commack, United States· Recruiting
  • Research Site
    Verified postcode
    Providence, United States· Recruiting
  • Research Site
    Verified postcode
    Ghent, Belgium· Not yet recruiting
  • Research Site
    Verified postcode
    Toronto, Canada· Not yet recruiting
  • Research Site
    Verified postcode
    Québec, Canada· Not yet recruiting
  • Research Site
    Verified postcode
    Beijing, China· Not yet recruiting
  • Research Site
    Verified postcode
    Chengdu, China· Suspended
  • Research Site
    Verified postcode
    Guangzhou, China· Suspended

Common questions

What is metastatic prostate cancer?

This means your prostate cancer has spread from your prostate gland to other parts of your body.

What does 'experimental treatment' mean?

It means AZD6621 is a new drug being tested, and doctors are still learning about how it works and whether it can help people.

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

Yes, in this study, everyone taking part will receive the AZD6621 treatment. There is no 'placebo' or dummy treatment.

How long will I be in the study?

The exact length varies. You will have regular visits for check-ups, and scans, for as long as the treatment is helping and it's safe for you to continue.

What does 'Phase 1/2' mean?

Phase 1 is about finding the safest dose. Phase 2 then tests that dose in more people to see how well it works and to gather more safety information.

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 Study to Learn How Safe AZD6621 is, How Well it Works, and…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

Discussion

Community discussion

Powered by our forum at community.patient.info. Please be respectful — this is not medical advice.