A Study of ASP3082 in Adults With Advanced Solid Tumors
This study is testing a new treatment called ASP3082 for adults who have advanced solid cancers with a specific genetic change known as KRAS G12D. These are cancers that doctors can't remove with surgery or have spread to other parts of the body, and usual treatments haven't worked or aren't suitable. The main goals are to find out if ASP3082 is safe, what side effects it might cause, and to work out the best dose to give. Sometimes, ASP3082 will be given on its own, and sometimes it will be given with another existing cancer drug called cetuximab. Later, it might also be given with other cancer treatments. The study has two main parts: first finding the right dose, and then testing that dose further.
At a glance
What is this study about?
This study is looking into a new treatment called ASP3082 for adults battling advanced solid cancers. These are cancers that doctors can't remove with surgery or have spread to other parts of the body. Importantly, this study is for people whose cancer has a specific genetic change called KRAS G12D. This is a common change in some cancers, and treatments that target it are a big focus in cancer research. You might be eligible if standard treatments for your cancer haven't worked well, your doctor thinks they won't help further, or you can't have them for other reasons.
The main aim of this study is to see how safe ASP3082 is and to find the best dose to give. It's a 'Phase 1' study, which means it's one of the first times this drug is being tested in people. Because of this, it's very focused on safety. Sometimes, ASP3082 will be given on its own, and other times it will be combined with another cancer drug called cetuximab. In a later part of the study, it might be tried with other common cancer medicines too.
Taking part in this study means that both you and the doctors looking after you will know you are receiving ASP3082. This is called an 'open-label' study. The treatment, given through a drip into a vein, will continue for a period, usually in treatment cycles of 21 or 28 days. You'll continue the treatment as long as it's helping and not causing too many side effects, or until you and your doctor decide it's time to stop.
Key takeaways
- This study is for adults with advanced solid cancers having a specific genetic change (KRAS G12D).
- It's a Phase 1 study, focused on checking the new drug ASP3082's safety and finding the right dose.
- ASP3082 may be given alone or with other cancer drugs like cetuximab, via a drip.
- Participants will have regular check-ups, blood tests, and scans.
- Participation is voluntary, and you can withdraw at any time.
- The study aims to find new options for patients when standard treatments are no longer effective.
Who may be eligible?
To be considered for this study, you need to be an adult (18 years or older) with a solid cancer that is advanced, meaning it's either spread (metastatic) or can't be removed by surgery. Your cancer must also have a specific genetic change called KRAS G12D. Your doctor will be able to check this with a special test if you don't already know.
It's important that you have already tried standard treatments for your cancer, but they are no longer helping, or your doctor feels you shouldn't continue with them. If your type of cancer is pancreatic cancer that has spread, and you haven't had chemotherapy for it before, you might also be eligible for specific parts of the study where ASP3082 is given with other treatments.
There are also some general health checks you'll need to pass to make sure you're well enough to take part. For instance, your doctors will check your overall physical health, and you'll need to have at least one part of your cancer that can be measured to see if the treatment is working.
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 cancer that is advanced (spread or unable to be surgically removed)?
- Has your doctor confirmed your cancer has the KRAS G12D genetic change?
- Have you already tried standard treatments for your cancer, but they are no longer helping, or you can't have them?
- Are you generally well enough for a clinical trial, as assessed by your doctor?
- If you have pancreatic cancer, have you not had chemotherapy for your advanced cancer before?
What does participation involve?
If you join this study, the treatment, ASP3082, will be given to you through a drip into a vein in your arm. This is called an infusion. Each period of treatment, called a cycle, will last either 21 or 28 days. You will continue to have these treatment cycles for as long as the treatment is still helping you, and you're not experiencing too many side effects that are hard to manage. You would also stop if your cancer starts to get worse, you decide to start a different cancer treatment, or you simply choose to stop participating.
Before you start, and regularly throughout the study, you'll have various check-ups, scans, and blood tests. These are to monitor your health, see how the treatment is affecting your body, and check if your cancer is responding. The study will also ask for a sample of your tumour tissue before you start, and sometimes during the treatment, to help researchers understand the cancer better.
Potential risks and benefits
Locations (53)
- City of Hope National Medical CenterVerified postcodeDuarte, United States· Recruiting
- UCLA Santa Monica Hematology OncologyVerified postcodeSanta Monica, United States· Recruiting
- Denver HealthONE Drug Development UnitVerified postcodeDenver, United States· Recruiting
- Smilow Cancer Center at Yale New Haven HospitalVerified postcodeNew Haven, United States· Recruiting
- Georgetown University HospitalVerified postcodeWashington D.C., United States· Recruiting
- University of Florida, Davis Cancer CenterVerified postcodeGainesville, United States· Recruiting
- Florida Cancer SpecialistVerified postcodeLake Mary, United States· Recruiting
- Florida Cancer Specialists & Research Institute SarasotaVerified postcodeSarasota, United States· Recruiting
- University of Kansas Medical CenterVerified postcodeWestwood, United States· Recruiting
- Beth Israel Deaconess Medical CenterVerified postcodeBoston, United States· Recruiting
- Dana Farber Cancer InstituteVerified postcodeBoston, United States· Recruiting
- Trinity Health Ann Arbor HospitalVerified postcodeYpsilanti, United States· Recruiting
Common questions
What does 'Solid Tumor' mean?
'Solid tumor' means a lump or mass of abnormal tissue, in contrast to blood cancers like leukaemia. Examples include cancers of the breast, lung, bowel, or pancreas.
What is a 'KRAS G12D mutation'?
This is a specific change in a gene called KRAS within your cancer cells. This change can make the cancer grow and spread. This study is specifically for cancers with this particular change.
What does 'advanced' cancer mean?
Advanced cancer means the cancer has either spread from where it started to other parts of the body (this is called metastatic) or it has grown large and can't be completely removed by surgery.
What is a 'Phase 1' study?
A Phase 1 study is usually the first time a new drug is tested in people. The main goals are to check if the drug is safe, look for side effects, and find the best dose to give.
Will I have to pay to be in this study?
No, you will not have to pay for the study drug or related medical care provided as part of the trial.
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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