A phase 1/2a, first-in-human, open-label, dose-escalating study with a safety expansion cohort to evaluate safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary anti-tumour activity of TAX2 in patients with relapsed/refractory advanced/metastatic solid tumours
This study is for people with advanced ovarian, bowel, pancreatic cancer, or melanoma whose current treatments are no longer working. It's an early-stage study, meaning it's one of the first times this new drug, called TAX2, is being tested in humans. The main goals are to check how safe the drug is, what side effects it might cause, and to find the right dose. Researchers will also look at how the drug moves through the body and if it shows any early signs of shrinking tumours. This is a crucial step in developing new treatments for these types of cancer, aiming to give patients more options when other therapies have been exhausted.
At a glance
What is this study about?
This research study is looking into a new treatment called TAX2. It's designed for people who have advanced cancer that has spread to other parts of the body (known as 'metastatic' cancer) and has either come back (relapsed) or not responded well to previous treatments. Specifically, it's for certain types of cancer: advanced ovarian cancer, bowel cancer that has spread, pancreatic cancer that has spread, and a type of skin cancer called melanoma that has spread.
This is a 'first-in-human' study, which means it's one of the very first times this drug is being given to people. It's happening in two main parts. The first part, called Phase 1, focuses on safety. Researchers will start with a small amount of the drug and slowly increase the dose for different groups of patients. They will carefully watch for any serious side effects to find the safest dose. The second part, Phase 2a, will then look more closely at this safe dose in a larger group of patients, continuing to monitor for side effects and how well the treatment is tolerated.
Alongside safety, the study will also look for early signs of how well TAX2 might work against the cancer. This includes checking if the tumours shrink or stop growing, how long the benefits last, and how long people live. Researchers will also study how the drug behaves in the body and how it affects various processes, looking for clues about how it might fight cancer. The overall aim is to explore if TAX2 could become a new treatment option for people with these specific cancers when other treatments are no longer effective.
Key takeaways
- Tests a new drug (TAX2) for advanced cancers.
- For ovarian, bowel, pancreatic, and melanoma that haven't responded to other treatments.
- First, checks safety and finds the right dose.
- Then, looks for early signs the drug helps fight cancer.
- Close monitoring for side effects throughout.
- Participation is voluntary, and you can withdraw at any time.
Who may be eligible?
To be able to join this study, suitable patients generally need to be at least 18 years old. There's no upper age limit mentioned.
You would be considered for this study if you have certain advanced cancers where other treatments have not been successful. These include advanced ovarian cancer, bowel cancer that has spread, pancreatic cancer that has spread, or melanoma that has spread to other parts of the body.
As this is a clinical trial, there will be other medical criteria to meet. For instance, doctors will need to check your general health, organ function, and specific details about your cancer to make sure 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.
- Are you 18 years old or older?
- Do you have advanced ovarian, bowel, pancreatic cancer, or melanoma that has spread?
- Have other treatments for your cancer already been tried and are no longer working?
- Are you able to attend regular hospital visits and have tests?
- Are you generally well enough to take part in a clinical trial?
What does participation involve?
If you decide to take part in this study, you'll be given the new drug TAX2. The study will involve regular visits to the clinic, especially in the beginning, where you'll have various tests. These tests will include blood samples to check how the drug is working in your body and to monitor for any side effects. You'll also have scans to see how your cancer is responding. The doctors and nurses will ask you how you're feeling and carefully record any symptoms you experience. The total length of your participation will depend on how you respond to the treatment and the study plan, but you will be monitored closely throughout.
Potential risks and benefits
Locations (2)
- —UnverifiedBelgium
- —UnverifiedFrance
Common questions
What kind of drug is TAX2?
TAX2 is a new drug being tested for advanced cancers, and this study is one of the first times it's being used in people.
What does 'relapsed/refractory' mean?
It means your cancer has either come back after treatment, or it hasn't responded to the treatments you've tried before.
What is the main goal of the study?
The main goal is to find out if TAX2 is safe, what side effects it might cause, and to find the right dose. It will also look for early signs that it might help treat cancer.
What are the specific cancers included?
The study includes advanced ovarian cancer, bowel cancer that has spread, pancreatic cancer that has spread, and melanoma that has spread.
Can I leave the study if I want to?
Yes, you have the right to withdraw from the study at any time without needing to give a reason, and it won't affect your medical care.
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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