A Phase II, Open-label, Multi-center, Basket Study of the ATR Kinase Inhibitor ART0380 Administered Orally as Monotherapy to Patients with Biologically Selected Advanced or Metastatic Solid Tumors (ARTIST)
This research study, called ARTIST, is looking at a new oral medicine named ART0380. It's for adults with advanced or metastatic solid cancers, which means cancers that have spread from where they started. The main goal is to find out if this medicine can shrink tumors or stop them from getting worse. This is a Phase 2 study, which means it's an earlier stage of research where doctors are trying to understand if the treatment works and what side effects it might have. Researchers will also be checking if the medicine is safe, how long people live without their cancer growing, and how long the medicine's effects last. Information about how the medicine moves through the body will also be collected.
At a glance
What is this study about?
This research study is testing a new drug called ART0380, which is taken by mouth. It’s designed for people who have advanced or metastatic solid tumors. This means the cancer started in one part of the body and has now spread to other areas. The study is called ARTIST, and it's a Phase 2 trial. In this phase, doctors are focusing on whether the new medicine can help shrink tumors or stop them from growing, and if it's generally safe for patients.
The main thing doctors want to see is how many patients have their tumors shrink or disappear after taking ART0380. They will also be looking at other important things, like how safe the medicine is, how long patients live without their cancer getting worse, how long the treatment's effects last, and the overall survival. This helps doctors get a full picture of how well the new medicine works and its benefits.
Finding new ways to treat advanced cancers is really important because these cancers can be challenging. This study aims to contribute to our understanding of ART0380 and whether it could become a helpful treatment option for patients in the future. By participating, patients help researchers learn more about new potential medicines.
Key takeaways
- New oral medicine ART0380 for advanced solid cancers.
- Aims to check if ART0380 can shrink tumors or stop their growth.
- Early stage (Phase 2) study, focusing on effectiveness and safety.
- Participation involves taking medicine and regular check-ups.
- Potential benefits include access to new treatment, but risks of side effects exist.
- Your doctor can tell you if you might be eligible.
Who may be eligible?
To be part of this study, you must be at least 18 years old. Both men and women are welcome to join. The study is specifically for people who have solid tumors that are advanced or have spread throughout the body.
There might be other health conditions or treatments that could prevent you from joining. For example, if you've recently had certain other cancer treatments or have specific ongoing health problems, you might not be able to participate. This is to make sure the study testing is safe and the results are clear.
It's very important to talk with your doctor if you're interested in this study. They can look at your full medical history and tell you if you meet all the specific requirements to take part.
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 a solid tumor that is advanced or has spread?
- Are you able to take medicine by mouth?
- Have you discussed this study with your cancer doctor?
What does participation involve?
If you decide to join this study, you'll be taking the new medicine, ART0380, by mouth. You would have regular appointments at the hospital or clinic. These visits will involve various tests, such as blood tests, scans (like CT or MRI) to check your tumors, and physical examinations. This is to monitor how the medicine is affecting your cancer and your general health, and to keep an eye on any side effects.
The study will last for a period of time where you continue to take the medicine as long as it's helping you and you're not experiencing severe side effects. Even after you stop taking the study medicine, there will likely be follow-up appointments to continue monitoring your health and the long-term effects of the treatment. The total duration of your involvement, including follow-up, will be explained in detail by the study team.
Potential risks and benefits
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Common questions
What kind of cancer is this study for?
It's for people with advanced or metastatic solid cancers, meaning cancers that have spread from their original location.
What is ART0380?
It's a new medicine taken by mouth that researchers are testing to see if it can help treat certain cancers.
Is this a new treatment?
Yes, ART0380 is an experimental medicine being studied for the first time in this patient group.
What is a 'Phase 2' study?
It means doctors are in an early stage of clinical research, mainly looking to see if the treatment works and what its side effects are.
Will I have to pay to be in the study?
Clinical trials typically cover the cost of the study medication and study-related visits. Please confirm this with the research team.
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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