A two-part, open-label, clinical study to assess the safety, tolerability and activity of intravenous doses of ICT01 in combination with low-dose subcutaneous interleukin-2 in patients with advanced solid tumors (EVICTION-2)
This research is a two-part study looking into new treatments for advanced cancers that have spread to other parts of the body. These include prostate, bowel (colorectal), pancreatic, melanoma (skin cancer), and ovarian cancers. The main goal is to check how safe a new medicine called ICT01 is when given into a vein, alongside a lower dose of another medicine called Proleukin, injected under the skin. Researchers will also be watching to see if this combination helps control the cancer. This study is for people aged 18 and over, and it's a first step in testing these drugs in humans.
At a glance
What is this study about?
This research study, called EVICTION-2, is looking for better ways to treat several advanced cancers. These include prostate cancer that hasn't responded to hormone treatment, bowel cancer, pancreatic cancer, melanoma (a type of skin cancer), and ovarian cancer – specifically when these cancers have spread to other parts of the body or can't be removed by surgery.
The study has two main parts. In the first part, the most important thing is to make sure the treatment is safe. Doctors will be carefully watching for any side effects and how well people tolerate the new drugs. In the second part, they will continue to monitor safety, but also focus on whether the treatment helps to control the cancer's growth or shrink the tumours.
The treatment involves a new drug called ICT01, which is given into a vein (intravenously), combined with a lower dose of an existing medicine called Proleukin, which is given as an injection just under the skin (subcutaneously). Researchers hope this combination will be a safe and effective way to fight these advanced cancers.
Key takeaways
- This study is for advanced prostate, bowel, pancreatic, melanoma, and ovarian cancers.
- It tests a new drug (ICT01) with an existing one (Proleukin).
- The main goals are to check safety and how well the treatment controls cancer.
- It's a first step in testing these drugs together in humans (Phase I/II study).
- Participants must be 18 or older and have one of the listed advanced cancers.
Who may be eligible?
To be considered for this study, you must be at least 18 years old. Both men and women can take part.
You would be considered if you have one of the following advanced cancers that has spread in your body:
* Prostate cancer that is no longer responding to usual hormone treatments. * Bowel (colorectal) cancer. * Pancreatic cancer. * Melanoma (a serious skin cancer) that has spread or cannot be removed by surgery. * Ovarian cancer.
There might be other health conditions or previous treatments that could mean you're not suitable for this study. The study team will review all your medical information carefully to see if it's right for you.
- Are you 18 years old or older?
- Do you have prostate, bowel, pancreatic, melanoma, or ovarian cancer that has spread?
- Is your prostate cancer resistant to standard hormone treatment?
- Is your melanoma cancer that has spread or cannot be surgically removed?
This is a guide only — the research team will confirm whether you can take part.
What does participation involve?
If you decide to take part, you will receive the study medications: ICT01 as a drip into your vein and Proleukin as an injection just under your skin. The study team will tell you the exact schedule for these treatments.
You will have regular check-ups, which include blood tests, checking your vital signs (like blood pressure and heart rate), ECGs (heart tracings), and physical examinations. These are to closely monitor your health, check for any side effects, and see how the treatment is affecting your cancer. The exact number of visits and the full duration of your participation will be explained by the study doctor.
Potential risks and benefits
Locations (2)
- —France
- —Germany
Common questions
What does 'advanced solid tumors' mean?
It means the cancer started in a solid organ and has spread to other parts of the body.
What are the medicines being tested?
The study is testing a new drug called ICT01, given with another medicine called Proleukin (also known as interleukin-2).
What does 'Phase I and Phase II' mean?
Phase I trials are the first time a drug is tested in people, focusing on safety. Phase II trials then look at how well the drug works, while still checking safety.
Will I know if the treatment is helping my cancer?
The doctors will monitor your cancer using scans and other tests to see if it is stable, shrinking, or growing.
Is this study suitable for everyone with these cancers?
No, there are strict rules about who can join. The study team will check your medical history to see if you meet all the requirements.
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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