Dose Escalation Phase 1 Study of IOA-289 in combination with gemcitabine/nab-paclitaxel
This research study is looking at a new treatment called IOA-289. It's being given together with chemotherapy medicines, specifically gemcitabine and nab-paclitaxel, to people who have pancreatic cancer that has spread to other parts of their body. This is an early phase study, meaning it's one of the first times this new medicine is being tested in people. The main goal is to find the right amount (dose) of IOA-289 that can be given safely when combined with the usual chemotherapy. Researchers will carefully watch for any side effects and how well the treatment is tolerated at different doses. This helps them understand if IOA-289 could be a helpful new option in the future for people with advanced pancreatic cancer.
At a glance
What is this study about?
This study is about exploring a new medicine, IOA-289, for people who have pancreatic cancer that has spread. Pancreatic cancer can sometimes be hard to treat, especially when it has spread to other parts of the body. Doctors are always looking for new and better ways to help people in this situation.
In this study, IOA-289 is being given together with treatments you might already know: gemcitabine and nab-paclitaxel. These are common chemotherapy medicines used to treat pancreatic cancer. The idea is to see if adding IOA-289 can make the existing treatments more effective, or if it can help in a new way.
Because this is an early-stage study, it's mainly focused on safety and finding the best dose. Researchers will start with a very small amount of IOA-289 and gradually increase it for different groups of participants, all while keeping a close eye on how people feel and any side effects. This careful approach helps ensure that the new medicine is given at a level that is both safe and has the potential to be helpful.
Key takeaways
- This study is for adults with pancreatic cancer that has spread.
- It tests a new medicine (IOA-289) alongside standard chemotherapy.
- The primary goal is to find a safe and effective dose of IOA-289.
- Participants will have regular medical check-ups and monitoring.
- Possible benefits include access to a new treatment; risks include unknown side effects.
- You can withdraw from the study at any time.
Who may be eligible?
To join this study, you need to be an adult, aged 18 or older. The study is open to both men and women. The researchers will be looking for people who have pancreatic cancer that has spread to other parts of their body. This means the cancer is considered 'metastatic'.
There will be other important health checks to see if this study is right for you. For example, doctors will need to make sure your other organs, like your liver and kidneys, are working well enough for you to safely receive the study treatments. They will also check if you have certain other medical conditions or are taking specific medicines that might interfere with the study treatments.
These checks are important because they help make sure the study treatments are as safe as possible for everyone involved. If you're interested, the study team will explain all the requirements in detail and help you understand if you might be a good fit.
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 pancreatic cancer that has spread?
- Is your general health good enough for treatment (e.g., organ function)?
- Are you able to attend regular clinic visits?
- Are you not currently pregnant or breastfeeding (if applicable)?
- Are you willing to follow the study's treatment plan?
What does participation involve?
If you decide to take part in this study, you will receive the new medicine, IOA-289, alongside the standard chemotherapy (gemcitabine and nab-paclitaxel). Doctors will closely monitor your health throughout the study. This will likely involve regular visits to the clinic for physical exams, blood tests, and possibly scans to see how your body is responding to the treatment and to check for any side effects. The exact schedule of visits will be explained to you, but typically, early-phase studies require more frequent visits initially.
You'll be given the study medication according to a specific plan set by the researchers. There will be careful instructions on how and when to take any medication given for the study. The total duration of your participation could vary, as the study aims to find the right dose and understand the early effects of the treatment. There will be a follow-up period after you stop receiving the study treatment, where doctors will continue to monitor your health for a period of time.
Potential risks and benefits
Locations (1)
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Common questions
What is the new medicine IOA-289 for?
IOA-289 is a new medicine being tested alongside standard chemotherapy for people with pancreatic cancer that has spread.
What does 'early-stage study' mean?
It means this is one of the first times the new medicine is being given to people. The main goal is to check for safety and find the correct dose.
Will I still receive chemotherapy?
Yes, in this study, IOA-289 is given in combination with the standard chemotherapy medicines gemcitabine and nab-paclitaxel.
Who can join this study?
Adults aged 18 or over with pancreatic cancer that has spread, who meet other specific health requirements, may be eligible.
Can I leave the study if I change my mind?
Yes, you can choose to leave the study at any time, for any reason, and it will not affect your regular medical care.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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