A Study of XL092 as Single-Agent and Combination Therapy in Subjects With Solid Tumors
This is an early-stage study (Phase 1) exploring a new treatment called XL092 for people with advanced solid tumours that can't be removed by surgery or have spread. We want to find out if XL092 is safe and what dose can be given, both when used by itself and when combined with other existing cancer drugs like Atezolizumab or Avelumab. Researchers will also look at how the drug behaves in the body and if it has any effect on the tumours. The study includes people with different types of cancer, such as kidney cancer, a specific type of breast cancer, prostate cancer that has spread, and bowel cancer. The main goal is to understand if this new treatment could be helpful for future patients.
At a glance
What is this study about?
This study is about a new drug called XL092 that doctors hope might help treat several types of advanced cancer. When we say 'advanced', it means the cancer has spread in the body or can't be removed by surgery. This is an early-stage study, often called a 'Phase 1' study. In this phase, the main goal is to find out if a new drug is safe for people, what dose can be given without causing too many problems, and how the drug works in the body. Doctors will also start to see if it has any effects on the cancer itself.
Researchers are looking at XL092 in two ways: first, on its own as a single treatment, and second, combined with other treatments that are already used for cancer, such as Atezolizumab and Avelumab. By testing these combinations, they hope to find out if XL092 works better when given alongside these other drugs. The study includes people with specific types of advanced cancers, including some kidney cancers, a particular kind of hormone-sensitive breast cancer, prostate cancer that has spread and isn't responding to hormone therapy, and bowel cancer.
The information gathered from this study is really important. It helps doctors understand if XL092 has the potential to become a new treatment option in the future. If the drug is found to be safe and shows promising signs against cancer, it might then be tested in larger studies with more people. This step-by-step process helps ensure new medicines are safe and effective before they are widely used.
Key takeaways
- This is an early-stage study (Phase 1) for advanced cancers.
- It tests a new drug, XL092, alone and with other known cancer drugs.
- The main goals are to check safety, find the best dose, and see if it fights cancer.
- Includes specific types of kidney, breast, prostate, and bowel cancer.
- Participation is voluntary, and you can withdraw at any time.
Who may be eligible?
To join this study, you generally need to have a solid tumour (meaning not a blood cancer) that has been checked by a doctor and can't be removed by surgery, has come back, or has spread to other parts of your body, and for which standard treatments aren't working well or you can't tolerate them. You must be at least 18 years old.
Depending on which part of the study you might join, you'll need to have a specific type of cancer. For example, some parts of the study are for people with certain kinds of kidney cancer that have been treated before but have gotten worse. Other parts are for people with a specific type of breast cancer (called hormone receptor positive and HER2 negative) that has spread or recurred after previous treatments.
The study also includes people with prostate cancer that has spread and is no longer responding to hormone therapy, as well as some patients with advanced bowel cancer. For bowel cancer, your tumour needs to have specific genetic features (KRAS/NRAS wild-type and not MSI-high/dMMR) and you need to have received certain standard chemotherapy treatments already.
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 tumour that can't be removed by surgery, has come back, or has spread?
- Are your current or past cancer treatments no longer working or causing too many side effects?
- Is your cancer one of these types: kidney, hormone-sensitive breast, advanced prostate, or specific types of bowel cancer?
- Are your doctors happy for you to consider joining a research study?
What does participation involve?
Taking part in this study would involve regular visits to the hospital or clinic for check-ups, blood tests, and scans to see how your body is reacting to the treatment and whether the cancer is changing. You would be given the study drug, XL092, either on its own or along with one of the other study drugs (Atezolizumab or Avelumab), as decided by the study doctors. The exact schedule of visits and treatments would be explained in detail, but you can expect frequent monitoring in the beginning. The total length of your participation would depend on how your body responds to the treatment and if you experience side effects, but it could last for many months as long as the treatment is helping and you are tolerating it well.
Potential risks and benefits
Locations (86)
- Exelixis Clinical Site #6Verified postcodeDuarte, United States
- Exelixis Clinical Site #49Verified postcodeLa Jolla, United States
- Exelixis Clinical Site #7Verified postcodeLos Angeles, United States
- Exelixis Clinical Site #84Verified postcodeLos Angeles, United States
- Exelixis Clinical Site #66Verified postcodeSan Francisco, United States
- Exelixis Clinical Site #71Verified postcodeStanford, United States
- Exelixis Clinical Site #15Verified postcodeLake Mary, United States
- Exelixis Clinical Site #24Verified postcodeMiami, United States
- Exelixis Clinical Site #11Verified postcodeAtlanta, United States
- Exelixis Clinical Site #80Verified postcodeAtlanta, United States
- Exelixis Clinical Site #41Verified postcodeIowa City, United States
- Exelixis Clinical Site #36Verified postcodeWestwood, United States
Common questions
What does a 'Phase 1' study mean?
Phase 1 is the earliest stage of human testing for a new drug. It mainly checks if the drug is safe, what the right dose is, and how it acts in the body.
What is XL092?
XL092 is a new drug being tested to see if it can help treat advanced solid tumours, either by itself or with other cancer medicines.
Will I definitely receive XL092?
Yes, everyone in this study will receive XL092, either alone or in combination with Atezolizumab or Avelumab.
What kinds of cancers are included?
This study is for specific types of advanced kidney cancer, a certain type of breast cancer, advanced prostate cancer, and specific forms of advanced bowel cancer.
Can I stop participating if I want to?
Yes, you can leave the study at any time, for any reason, and it will not affect your ongoing medical care.
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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