Safety, Pharmacokinetics, and Preliminary Efficacy of VIR-5500 (AMX-500) in Prostate Cancer
This research is investigating a new drug called VIR-5500 for men with prostate cancer. Specifically, it's for cancer that has spread to other parts of the body (metastatic) and is no longer being controlled by common hormone treatments. The study has a few goals: first, to see if VIR-5500 is safe to use and how well people tolerate it. Second, to understand how the body processes the medicine. And third, to get an early idea of whether it can help shrink or slow down the cancer. Researchers will test VIR-5500 by itself and in combination with other existing prostate cancer medicines, such as enzalutamide or darolutamide. The study is a 'Phase 1' trial, meaning it's one of the first steps in testing a new treatment in people.
At a glance
What is this study about?
This study is for men with prostate cancer, particularly when the cancer has spread and is no longer responding to standard hormone treatments. Doctors call this 'hormone-refractory prostate cancer.' The main goal is to learn more about a new medicine called VIR-5500. This is an early-stage study, known as 'Phase 1,' which means researchers are primarily focused on making sure the treatment is safe for people and finding the right dose.
The study will look at VIR-5500 in different ways. Initially, it will be given on its own to see how the body handles it and to check for any side effects. Once researchers have a good idea of the best dose, they will also test VIR-5500 in combination with other established prostate cancer medicines, like enzalutamide or darolutamide. This helps them understand if VIR-5500 can be even more effective when used alongside existing treatments.
Over the course of about four years, the study will gather important information. It will help doctors understand how VIR-5500 works inside the body, its potential benefits in slowing or shrinking prostate cancer, and any side effects. This knowledge is crucial for deciding if VIR-5500 should be studied further in larger clinical trials.
Key takeaways
- This study is testing a new medicine, VIR-5500, for advanced prostate cancer.
- It's for prostate cancer that has spread and is resistant to hormone therapy.
- The main goals are to check safety, how the medicine works, and early signs of effectiveness.
- VIR-5500 will be tested both alone and with other established prostate cancer drugs.
- The study is expected to last for up to four years.
- It's a 'Phase 1' study, focusing on safety and dosage.
Who may be eligible?
To join this study, men must have prostate cancer that has spread to other parts of the body and is no longer responding to hormone therapy. You would typically have already been treated with certain types of hormone-blocking drugs (like abiraterone or enzalutamide) and chemotherapy (like docetaxel).
For some parts of the study, you might also need to have received specific advanced radiation treatments that target prostate cancer cells. However, if your cancer has certain unusual features, serious infections, or if the cancer is very close to vital organs or has spread to your brain or spinal cord, you would likely not be able to join. Your doctor will carefully review all your medical history 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.
- Do I have prostate cancer that has spread to other parts of my body?
- Is my prostate cancer no longer responding well to hormone treatments?
- Have I already received certain hormone-blocking medicines (e.g., enzalutamide)?
- Have I had chemotherapy for my prostate cancer?
- Am I generally considered unsuitable for other standard treatments?
- Am I a man, aged 18 or older?
What does participation involve?
If you decide to take part, the study could last for up to four years. You would have regular visits to the clinic, where doctors and nurses would check your health, give you the study medicine (VIR-5500, either alone or with another approved prostate cancer drug), and perform various tests. These tests might include blood samples, urine samples, and scans like CT, MRI, or bone scans to monitor your cancer and check how your body is reacting to the treatment. You would also be asked about any side effects you experience. Throughout the study, the research team would be there to support you and answer any questions.
Potential risks and benefits
Locations (24)
- Duarte Cancer CenterVerified postcodeDuarte, United States· Recruiting
- Lennar Foundation Cancer CenterVerified postcodeIrvine, United States· Recruiting
- UCI Health Chao Family Comprehensive Cancer CenterVerified postcodeOrange, United States· Recruiting
- Stanford UniversityVerified postcodePalo Alto, United States· Recruiting
- University of CaliforniaVerified postcodeSan Francisco, United States· Recruiting
- Chicago Cancer CenterVerified postcodeZion, United States· Recruiting
- MD Anderson Cancer CenterVerified postcodeHouston, United States· Recruiting
- NEXT VirginiaVerified postcodeFairfax, United States· Recruiting
- Fred Hutchinson Cancer Research CenterVerified postcodeSeattle, United States· Recruiting
- AU61002Verified postcodeDarlinghurst, Australia· Recruiting
- AU61001Verified postcodeMelbourne, Australia· Recruiting
- ES34001Verified postcodeBarcelona, Spain· Recruiting
Common questions
What kind of prostate cancer is this study for?
It's for prostate cancer that has spread to other parts of the body and is no longer controlled by standard hormone treatments.
What is VIR-5500?
It's a new medicine being tested to see if it's safe and effective for prostate cancer.
Will I receive other treatments alongside VIR-5500?
Some parts of the study will give VIR-5500 alone, while others will combine it with existing prostate cancer medicines like enzalutamide or darolutamide.
How long would I be in the study?
The study could last for up to about four years.
What does a 'Phase 1' study mean?
It's an early stage of testing a new medicine in people, mainly to check its safety and find the right dose.
How to find out more
Astellas Pharma Global Development, Inc
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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