A Phase 2, Randomized, Open-Label Study of Two Dose Levels of Vobramitamab Duocarmazine in Participants with Metastatic Castration-Resistant Prostate Cancer (TAMARACK)
This study is for men with advanced prostate cancer that has spread to other parts of the body and is no longer responding to regular hormone treatments. It's called the TAMARACK study and it's testing a new drug called MGC018 (also known as vobramitamab duocarmazine). The researchers want to compare two different dose levels of MGC018 to see which one works better and is safer. They will also give participants a common steroid medicine called prednisolone alongside the new drug. The main goal is to see if the new medicine can stop the cancer from growing or spreading for longer. They will also look at how it affects other cancer markers and people's general well-being. This is a Phase II study, which means it's still in the earlier stages of development.
At a glance
What is this study about?
This study, called TAMARACK, is looking for a new way to treat prostate cancer that has spread to other parts of the body (this is called metastatic cancer) and has stopped responding to hormone treatments that usually keep it in check (this is called castration-resistant).
The main medicine being tested is called MGC018, which is also known as vobramitamab duocarmazine. The researchers want to give this new medicine at two different dose levels to see which one is more effective and has fewer side effects. Participants will also receive a standard steroid called prednisoloneと一緒に. The aim is to find out if this new treatment can help slow down the cancer's growth or spread for a longer time.
They will measure how long it takes for the cancer to get worse, how the treatment affects a blood marker for prostate cancer called PSA, and how much the tumours shrink. They will also carefully monitor any side effects to understand how safe the new medicine is. This is a Phase 2 study, which means it's an earlier-stage clinical trial where scientists are trying to learn more about the drug's effectiveness and safety in a smaller group of people after it has already been shown to be safe in a very small initial group.
Key takeaways
- This study evaluates a new treatment (MGC018) for advanced prostate cancer that resistant to standard hormone treatment.
- It aims to see which of two different doses of the new medicine is most effective and safe.
- The study also includes a standard steroid medicine, prednisolone.
- Participants will have regular check-ups, tests, and scans.
- Being in a clinical trial means you might access new treatments, but there are also potential risks.
- You can stop participating in the study at any time.
Who may be eligible?
This study is looking for men who have advanced prostate cancer. This means their cancer has spread to other parts of their body, and it's no longer responding to the typical hormone treatments that doctors use.
To be considered for this study, you must be at least 18 years old. There is no upper age limit, meaning older men can also take part if they meet the other requirements.
Your doctors will need to check other things about your health and your cancer to make sure this study is right for you and that taking part would be safe.
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.
- Are you a man?
- Are you 18 years old or older?
- Do you have prostate cancer that has spread to other parts of your body?
- Is your prostate cancer no longer responding to hormone treatments?
What does participation involve?
If you join this study, you would receive the new medicine, MGC018, along with standard prednisolone. You would have regular visits to the hospital or clinic, which would involve check-ups, blood tests, and scans to monitor your health and how the treatment is working. Doctors would also carefully record any side effects you experience.
The specific schedule of visits and tests would be explained in detail by the study team. You would be on the study treatment for as long as it is helping you and you are not experiencing severe side effects. Even after you stop the treatment, you would likely have follow-up appointments to see how you are doing over time. The total duration of your participation could vary greatly depending on how your body responds to the treatment.
Potential risks and benefits
Locations (7)
- —UnverifiedBelgium
- —UnverifiedGermany
- —UnverifiedFrance
- —UnverifiedItaly
- —UnverifiedPoland
- —UnverifiedSpain
- —UnverifiedCzechia
Common questions
What kind of cancer is this study for?
It's for prostate cancer that has spread to other parts of the body and is no longer responding to standard hormone treatments.
What are they testing?
They are testing a new medicine called MGC018 (vobramitamab duocarmazine) at two different dose levels to see if it can slow down cancer growth.
Who can join the study?
Adult men (18 years or older) with this specific type of advanced prostate cancer can be considered.
Will I receive other medicines?
Yes, you will also be given a steroid medicine called prednisolone alongside the new treatment.
What does Phase 2 mean?
It means this is an earlier stage of drug testing, where researchers are learning more about how well the medicine works and its safety in a group of patients.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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