Phase 1-2 Study of the Safety, Pharmacokinetics, and Preliminary Activity of ASTX660 in Subjects with Advanced Solid Tumors and Lymphomas
This study is about a new medicine called Tolinapant. It's being tested in people who have advanced solid tumours or lymphomas that haven't responded well to other treatments, or have come back. This is an early-stage study, meaning it's one of the first times this medicine is given to people. The main thing the researchers want to find out is how safe Tolinapant is and if it causes any serious side effects. They will also look at how the body processes the medicine. In advanced stages of the study, they will check if the medicine helps to slow down or shrink the cancer. This information helps doctors understand if Tolinapant could be a helpful treatment in the future.
At a glance
What is this study about?
This research study is looking at a new medicine called Tolinapant (also known as ASTX660). It's designed for adults who have certain advanced cancers, including some types of solid tumours (like those in the head and neck, or cervical cancer that hasn't responded to usual treatments) and lymphomas (cancers of the immune system, such as Diffuse Large B-cell Lymphoma or T-cell Lymphoma) that have spread or can't be removed by surgery. This is an important step because these cancers can be difficult to treat.
The study is split into two main parts, Phase 1 and Phase 2. In Phase 1, the main focus is on safety. Researchers will give different doses of Tolinapant to a small group of people to see what side effects occur and what the highest safe dose might be. They will also learn how the body takes in, uses, and gets rid of the medicine. In Phase 2, more people will join, and the researchers will continue to watch for safety while also carefully checking if the medicine helps to fight the cancer. This could mean seeing if tumours get smaller or if the cancer stops growing for a period.
By doing this study, doctors hope to learn if Tolinapant is a safe and potentially effective treatment option for people with these advanced cancers. Finding new ways to treat cancer is always a priority, and studies like this help medical science move forward to find better treatments for patients in the future.
Key takeaways
- This study is testing a new medicine called Tolinapant for specific advanced cancers.
- It's an early-stage study, mainly focused on safety and understanding how the body uses the medicine.
- Researchers will also look for signs that the medicine might help to fight the cancer.
- The study is for adults over 18 with certain types of solid tumours or lymphomas.
- Participation is voluntary, and you can withdraw at any time.
Who may be eligible?
To join this study, you must be at least 18 years old. The study is open to both men and women.
You would be considered for this study if you have certain advanced cancers that are either solid tumours (like some head and neck cancers or cervical cancer that hasn't gotten better with standard treatments) or lymphomas (a type of blood cancer, like specific kinds of T-cell or B-cell lymphoma). These cancers must be either spread to other parts of your body, or they can't be removed by surgery, or they haven't responded well to previous treatments.
There might be other health conditions or medications that would mean this study isn't right for you, or specific tests you'd need to pass before joining. The study team will review all your medical information to see if you meet all the requirements.
- Are you 18 years old or older?
- Do you have advanced head and neck cancer, cervical cancer, or certain types of lymphoma (Diffuse Large B-cell or T-cell lymphoma) that hasn't responded to standard treatments or has returned?
- Has your cancer spread or can it not be removed by surgery?
- Are you able to attend regular appointments for check-ups and tests?
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 in this study, you will be given the new medicine, Tolinapant. The number of visits to the clinic will depend on which stage of the study you are in, but you can expect regular appointments for check-ups, blood tests, and scans. These tests are important to see how your body is handling the medicine and if your cancer is responding to the treatment. You will be closely monitored for any side effects. The total length of time you participate in the study will vary, but it will involve ongoing assessments and follow-up care until your time in the study is complete.
Potential risks and benefits
Locations (2)
- —Spain
- —Italy
Common questions
What is Tolinapant?
Tolinapant is a new medicine being tested in this study to see if it can help treat certain advanced cancers.
What does 'advanced solid tumours and lymphomas' mean?
It means cancers that have spread from where they started or can't be removed by surgery, and also specific types of blood cancers that affect the immune system.
Is this medicine available to everyone?
No, Tolinapant is currently only available to people who qualify for and decide to take part in this research study. It's not yet approved for general use.
What is the main purpose of this study?
The main purpose is to see how safe the new medicine is and how the body handles it. It also checks if the medicine has any effect on the cancer.
What if I decide I don't want to be in the study anymore?
You are free to leave the study at any time, for any reason, without it affecting your other 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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