A Phase 1, Open-Label, Multicenter Study of JANX007 in Subjects with Metastatic Castration-Resistant Prostate Cancer
This clinical trial is testing an experimental medicine called JANX007 for men with advanced prostate cancer. It is aimed at a condition called metastatic castration-resistant prostate cancer. This means the cancer has spread to other parts of the body and no longer responds well to standard hormone-lowering treatments. Because this is a Phase 1 study, it is one of the first times JANX007 is being given to people. The main purpose is to check safety, find the most suitable dose, and watch closely for any side effects. Researchers also want to see how the body processes the drug and whether it shows early signs of helping to control the cancer. Taking part involves regular hospital visits, health checks, and blood tests. Men aged 18 or older with this type of prostate cancer may be considered for the trial.
At a glance
What is this study about?
Prostate cancer is one of the most common cancers in men. In many cases, it grows slowly and can be managed effectively. However, in some men, the cancer spreads to other areas of the body, such as the bones or lymph nodes. Doctors often use hormone therapy to slow the cancer down, but over time, the tumour cells can adapt and start growing again. When this happens, it is known as metastatic castration-resistant prostate cancer, and new treatment options are urgently needed.
This trial is investigating an experimental drug called JANX007. The drug is designed to help the body's own immune system find and attack prostate cancer cells. Because JANX007 is a new medicine, doctors need to study it very carefully in a small group of patients before it can be made widely available.
This study is a Phase 1 trial, which focuses primarily on safety. The medical team wants to find out what dose of JANX007 is safe to give, how the body handles the medicine, and what kind of side effects might occur. Although early-stage studies are not guaranteed to improve a patient's condition, the information gathered is vital for developing better treatments for men facing advanced prostate cancer in the future.
Key takeaways
- The trial tests an experimental drug called JANX007 for advanced prostate cancer.
- It is a Phase 1 study focused on safety, side effects, and finding the right dose.
- Open to men aged 18 and older whose cancer has spread and resists hormone therapy.
- Requires regular hospital visits for treatment, scans, and blood tests.
- Participation is entirely voluntary, and you can withdraw at any time.
Who may be eligible?
This study is open to adult men aged 18 and over who have been diagnosed with advanced (metastatic) prostate cancer that has continued to grow despite standard hormone treatments.
To be considered, participants generally need to be well enough to carry out daily activities and attend regular hospital appointments. Doctors will also check that your major organs, such as your heart, liver, and kidneys, are working well enough to safely handle a new medicine.
You may not be able to join if you have certain other serious medical conditions, an active severe infection, or if you have recently received other experimental treatments. The trial doctor will review your full medical history and perform tests to see if the study is safe and appropriate 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.
- I am a man aged 18 or older.
- I have been diagnosed with advanced (metastatic) prostate cancer.
- My cancer has continued to grow despite standard hormone treatments.
- I am well enough to attend regular hospital appointments for treatment and tests.
- I am willing to try an experimental medicine and have regular health checks.
What does participation involve?
Taking part in this study means visiting a specialist hospital clinic on a regular basis. You will receive the study drug, JANX007, under the close supervision of a medical team. Before and during treatment, you will have various routine health checks. These include blood and urine tests, physical examinations, heart traces (ECGs), and imaging scans (such as CT or bone scans) to monitor your general health and see how the cancer is responding. The trial staff will also ask you to report any symptoms or side effects you notice. The study lasts for several months, and you will be followed up afterwards to continue checking on your wellbeing. You will be told the exact schedule of visits before you decide whether to join.
Potential risks and benefits
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Common questions
What does Phase 1 mean?
A Phase 1 trial is an early-stage study. Its main goal is to test the safety of a new medicine, identify side effects, and work out the best dose to use in humans.
Will I have to pay for the trial medicine?
No. The study drug and all trial-related medical tests are provided free of charge. Some studies also help cover travel expenses to and from the clinic.
Can I leave the study if I change my mind?
Yes. You can choose to stop taking part at any time. Your doctors will continue to support you and discuss other available treatment options.
Will this drug cure my prostate cancer?
Phase 1 trials are designed to test safety rather than cure disease. While doctors hope the drug will help control the cancer, they cannot guarantee a direct personal health benefit.
Can I still see my regular GP or cancer doctor?
Yes. The trial team will work alongside your usual healthcare team and keep them updated on your treatment and progress.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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