A Study to Find a Suitable Dose of ASP5834 in Adults With Solid Tumors
This study is for adults with specific types of solid tumours, like lung, bowel, or pancreatic cancer, that have a particular gene change called a KRAS mutation. We’re testing a new treatment, ASP5834, to see what dose is safe and effective when given alone or, for some bowel cancers, with an existing drug called panitumumab. This is the first time ASP5834 is being used in people, so we're carefully watching for any side effects and how the body handles it. Participants will have regular clinic visits for checks, scans, and to make sure they are comfortable. The study aims to help those whose cancers haven't responded well to standard treatments.
At a glance
What is this study about?
Our bodies are made of tiny building blocks called cells, and inside each cell are genes. Genes act like instruction manuals, telling our bodies how to grow and work. Sometimes, a change or 'mutation' can happen in a gene, like one called KRAS. When the KRAS gene changes, it can make faulty proteins that cause cancer cells to grow and spread.
This study is looking at a new treatment called ASP5834. Researchers believe ASP5834 might work by targeting these faulty proteins made by the changed KRAS gene, helping to stop cancer growth. We’re testing ASP5834 in adults who have different types of solid tumours (cancers that form solid lumps, not like blood cancers) that have this specific KRAS gene change. For some people with bowel cancer, ASP5834 might be given along with another cancer medicine called panitumumab, which is already used to treat bowel cancer.
Because ASP5834 hasn't been given to people before, the main goals of this study are to carefully find the safest and most effective dose. We’ll also be looking closely at how ASP5834 affects the body and if it causes any side effects. This important first step helps us understand if ASP5834 could be a helpful treatment option in the future for people with these specific cancers.
Key takeaways
- This study tests a new cancer drug, ASP5834, for solid tumours with a specific KRAS gene change.
- It's the first time ASP5834 is being given to people, focusing on finding a safe dose and checking for side effects.
- Some people with bowel cancer (colorectal cancer) may receive ASP5834 with panitumumab.
- Participants will have regular clinic visits, blood tests, and scans to monitor their health and treatment effects.
- The study is for adults whose cancer hasn't responded to standard treatments or who can't receive them.
Who may be eligible?
This study is for adults aged 18 or over. You might be able to take part if you have a solid tumour that has spread to nearby tissue, can't be removed by surgery, or has spread to other parts of your body. Importantly, your cancer must have a specific change (mutation) in a gene called KRAS.
You would usually be considered if standard treatments haven't worked for your cancer, or if you can't have those standard treatments for other reasons. However, if you have certain other serious health issues, such as specific heart conditions, uncontrolled cancer in your nervous system, certain lung problems, serious infections, or have recently had a stroke, you might not be able to join.
If you have pancreatic cancer, you would need to have had specific previous treatments or be unable to have them. Your doctor will carefully check all your medical history to see if this study is right 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 an adult (18 or older)?
- Do you have a solid tumour that has spread or cannot be removed by surgery?
- Does your cancer have a specific KRAS gene change?
- Have standard cancer treatments not worked for you, or can you not have them?
- Do you not have certain serious heart problems, uncontrolled brain cancer, or severe lung conditions?
What does participation involve?
If you join this study, ASP5834 (and sometimes panitumumab) will be given to you through a drip into a vein. Each cycle of treatment will last either 21 or 28 days, and you'll continue treatment as long as it's helping and not causing too many side effects, or until your cancer gets worse. This is an 'open-label' study, which means both you and the medical team will know which treatment you are receiving.
The study will have two main parts. In Part 1, small groups of people will receive carefully increasing doses of ASP5834 to find the safest and most suitable amounts. In Part 2, more groups of people will receive the best doses identified in Part 1. You will have more frequent clinic visits, especially during the first two treatment cycles, so the study doctors can carefully check your health, look for any side effects, and see how your cancer is responding with scans. They might also take extra cancer samples. After you stop treatment, you'll have follow-up visits for about a year to monitor your health. The number of visits will vary depending on your individual health.
Potential risks and benefits
Locations (20)
- UCLA Santa Monica Hematology OncologyVerified postcodeSanta Monica, United States· Recruiting
- Winship Cancer Institute at Emory UniversityVerified postcodeAtlanta, United States· Recruiting
- Ochsner HealthVerified postcodeJefferson, United States· Recruiting
- START MidwestVerified postcodeGrand Rapids, United States· Recruiting
- Washington University School of MedicineVerified postcodeSt Louis, United States· Recruiting
- Hackensack University Medical CenterVerified postcodeHackensack, United States· Recruiting
- Roswell Cancer InstituteVerified postcodeBuffalo, United States· Recruiting
- Memorial Sloan Kettering Cancer CenterVerified postcodeNew York, United States· Recruiting
- University Hospitals - UH Cleveland Medical CenterVerified postcodeCleveland, United States· Recruiting
- NEXT Oncology DallasVerified postcodeIrving, United States· Recruiting
- NEXT Oncology VirginiaVerified postcodeFairfax, United States· Recruiting
- Site FR33003Verified postcodeBordeaux, France· Recruiting
Common questions
What is a 'solid tumour'?
A solid tumour is a mass of abnormal cells that forms a lump, unlike blood cancers. Examples include lung cancer, bowel cancer, and pancreatic cancer.
What is a 'KRAS gene mutation'?
It's a specific change in a gene called KRAS that can make cells grow out of control. This study is for cancers with this particular change.
What does 'unresectable' mean?
This means the cancer cannot be completely removed through surgery, usually because of its size or location.
Will I definitely get the new drug ASP5834?
Yes, everyone in this study will receive ASP5834, either on its own or with panitumumab if you have bowel cancer. This is not a study where you might get a dummy treatment.
How long will I be in the study?
You will receive treatment until it's no longer helping or you experience too many side effects. After treatment, you'll have follow-up checks, and the whole study is expected to last about a year for each person.
How to find out more
Astellas Pharma Global Development, Inc.
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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