Study of IDE196 in Patients With Solid Tumors Harboring GNAQ/11 Mutations or PRKC Fusions
This research study is investigating a new medication called IDE196 for people with certain advanced solid cancers, including a type of eye cancer called uveal melanoma, skin cancer, or bowel cancer. These cancers must have particular genetic faults, known as GNAQ/11 mutations or PRKC fusions. The main goals are to find out if IDE196 is safe and how well it works. Researchers are testing IDE196 on its own and in combination with two other approved cancer drugs, binimetinib and crizotinib. The study has different stages: an early stage (Phase 1) to find the right dose, and a later stage (Phase 2) to see how effective that dose is. Some parts of the study looking at IDE196 alone or with binimetinib have already finished taking new patients.
At a glance
What is this study about?
This research study is designed to help us learn more about a new medicine called IDE196. It's for people who have advanced solid cancers, which means the cancer has spread from where it started. Specifically, it's for cancers that have certain genetic changes or 'faults' – imagine a tiny spelling mistake in the cancer's instruction manual – called GNAQ or GNA11 mutations, or PRKC fusions. These faults can be found in different types of cancer, including melanoma (a type of skin cancer, and specifically a rare kind that affects the eye called uveal melanoma) and bowel cancer, as well as other solid tumours.
The main idea behind this study is to see if IDE196 can safely and effectively treat these cancers. Researchers are testing IDE196 in a few ways: they're giving it on its own, and they're also trying it in combination with two other existing cancer drugs, binimetinib and crizotinib. The study is split into stages. Earlier stages focused on finding the safest and most effective dose of IDE196, both by itself and in combination with the other drugs. Later stages focused on seeing how well these doses work against the cancer.
It's important to know that some parts of this study have already finished taking new patients. For example, the parts looking at IDE196 on its own and IDE196 combined with binimetinib are no longer enrolling. This kind of research helps doctors understand new treatments better, so they can find new ways to help people living with cancer.
Key takeaways
- This study investigates a new drug, IDE196, for advanced cancers with specific genetic changes.
- It's exploring IDE196 alone and in combination with other existing cancer drugs.
- The study aims to check the safety and effectiveness of IDE196.
- It targets cancers like uveal melanoma, cutaneous melanoma, and colorectal cancer.
- Some parts of the study are no longer accepting new patients.
Who may be eligible?
To join this study, you need to be at least 18 years old. You must have a diagnosis of certain advanced solid cancers, such as metastatic uveal melanoma (a type of eye cancer that has spread), cutaneous melanoma (skin cancer), or bowel cancer, and these cancers need to have specific genetic changes (GNAQ/11 mutations or PRKC fusions). Your cancer might be new or it might have come back after previous treatments.
There are also some general health checks. For example, your organs (like your liver and kidneys) need to be working well, and you should be generally well enough to take part. For women who could become pregnant and men, you would need to use effective birth control during the study.
Some things might mean you can't join. For instance, if you've already had a specific type of treatment called a PKC inhibitor, or if you have certain infections like HIV or active Hepatitis B or C. Also, if your cancer has spread to your brain and is causing symptoms, you usually wouldn't be able to join. Your doctor will carefully review all your medical information 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 at least 18 years old?
- Do you have advanced uveal melanoma, cutaneous melanoma, colorectal cancer, or another solid tumour?
- Does your cancer have GNAQ/11 mutations or PRKC fusions?
- Are you generally well enough to take part and do your organs work properly?
- Have you discussed birth control if you are of childbearing potential?
What does participation involve?
If you join this study, you would receive the new drug IDE196, either on its own or in combination with binimetinib or crizotinib. The study involves regular visits to the hospital for checks, which would include blood tests, scans (like CT scans) to see how the cancer is responding, and general health assessments. You'd also be asked questions about how you're feeling and any side effects you might be experiencing. Some people might need to have a new biopsy (a small sample of tissue taken) if the doctors need more information about their cancer. The exact number of visits and the total length of time you'd be in the study would depend on which part of the study you join and how your body responds to the treatment. This will all be explained in detail by the study team.
Potential risks and benefits
Locations (15)
- UCLA Medical CenterVerified postcodeLos Angeles, United States· Recruiting
- San Francisco Oncology AssociatesVerified postcodeSan Francisco, United States· Active not recruiting
- SCRI - DenverVerified postcodeDenver, United States· Recruiting
- University of IowaVerified postcodeIowa City, United States· Active not recruiting
- Cancer Hematology Centers Western MichiganVerified postcodeGrand Rapids, United States· Active not recruiting
- Columbia University Medical Center - Herbert Irving PavilionVerified postcodeNew York, United States· Active not recruiting
- Duke University Medical CenterVerified postcodeDurham, United States· Recruiting
- University of Cincinnati Cancer CenterVerified postcodeCincinnati, United States· Recruiting
- The Cleveland Clinic FoundationVerified postcodeCleveland, United States· Active not recruiting
- Sidney Kimmel Cancer Center at Thomas Jefferson UniversityVerified postcodePhiladelphia, United States· Recruiting
- The Sarah Cannon Research Institute/Tennessee OncologyVerified postcodeNashville, United States· Recruiting
- The University of Texas MD Anderson Cancer CenterVerified postcodeHouston, United States· Recruiting
Common questions
What is IDE196?
IDE196 is a new experimental drug being tested to treat certain advanced cancers with specific genetic changes.
What kind of cancers is this study for?
This study is for advanced solid cancers like a type of eye cancer (uveal melanoma), skin cancer (cutaneous melanoma), or bowel cancer, that have specific genetic changes called GNAQ/11 mutations or PRKC fusions.
Is IDE196 given alone or with other drugs?
IDE196 is being tested both on its own and in combination with two approved cancer drugs, binimetinib and crizotinib.
Are new patients still being accepted into this study?
Some parts of the study, specifically looking at IDE196 alone and IDE196 with binimetinib, have finished taking new patients. Your doctor can tell you if any other parts are still open.
What are GNAQ/11 mutations or PRKC fusions?
These are specific genetic changes or 'faults' found in the cancer cells that the new drug, IDE196, is designed to target.
How to find out more
IDEAYA Clinical Trials
Always speak to your GP or specialist before deciding to take part in a study.
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