A First-in-Human Study of Highly Selective FGFR2 Inhibitor, RLY-4008, in Patients With Intrahepatic Cholangiocarcinoma (ICC) and Other Advanced Solid Tumors
This research study is looking at a new drug called RLY-4008. It's designed for people who have advanced cancer, particularly a type of liver cancer known as cholangiocarcinoma, and other solid tumors. This is one of the first times this drug is being used in people. The main goals are to find a safe and effective dose of RLY-4008, understand any side effects it might cause, and see if it can help shrink the tumors or keep them from growing further. Doctors will carefully monitor participants to see how their bodies react to the treatment and measure any changes in their cancer. The study is divided into different parts to gather all this important information.
At a glance
What is this study about?
This study is a clinical trial looking into a new medicine called RLY-4008. It's designed for people who have advanced cancer, including a specific type of liver cancer called cholangiocarcinoma. The main idea behind RLY-4008 is to target a specific growth pathway in cancer cells, which researchers hope will help stop the cancer from growing.
Because this is a new medicine, the study will happen in phases. The first phase is about understanding how safe the medicine is for people and finding the best dose to use. Doctors will pay very close attention to any side effects. Later phases will focus on whether the medicine actually makes tumors shrink or stops them from growing, and for how long these effects last. They will also look at how the medicine moves through your body and if it affects certain markers in your blood.
Taking part in this kind of study helps doctors learn more about new treatments. The information gathered will be very important for deciding if RLY-4008 could become a treatment option in the future for people with these types of cancer.
Key takeaways
- This study is testing a new drug, RLY-4008, for advanced cancers.
- It's mainly for a type of liver cancer called cholangiocarcinoma and other solid tumors.
- The main goals are to check the drug's safety, find the best dose, and see if it shrinks tumors.
- Participants will have regular medical check-ups and scans.
- You can stop participating at any time.
Who may be eligible?
To join this study, people generally need to be at least 18 years old. Both men and women can participate. The study is looking for people who have been diagnosed with a type of cancer called cholangiocarcinoma, which is a cancer that starts in the bile ducts of the liver, or other advanced solid tumors.
Because this is a specific type of drug targeting certain pathways, it's likely that a doctor will need to check if your cancer has specific genetic changes (called FGFR2 alterations) that the medicine is designed to target. You would also need to be well enough to take part in the study, which means having good general health and certain organ functions working properly, such as your kidneys and liver, as assessed by the study doctors.
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 aged 18 years or older?
- Do you have advanced cholangiocarcinoma or another solid tumor?
- Are you able to attend regular hospital appointments?
- Are you generally well enough to participate in a clinical trial?
What does participation involve?
If you decide to join this study, you would be taking the new medicine, RLY-4008, as directed by the study team. You would have regular visits to the hospital or clinic, which would involve different checks and tests. These might include blood tests, scans (like CT or MRI) to see how your cancer is responding, and assessments of your general health and any side effects you might be experiencing.
These visits would be frequent at the beginning of the study, and then might become less often if you continue to do well on the treatment. The study doctors and nurses would carefully explain the schedule and what to expect at each visit. The total length of your participation would depend on how your body responds to the treatment and how you are feeling, potentially continuing as long as the medicine is helping and you are tolerating it well.
Potential risks and benefits
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Common questions
What is cholangiocarcinoma?
It's a rare type of cancer that starts in the bile ducts, which are tubes that carry digestive fluid from the liver.
What does 'advanced solid tumors' mean?
It means cancers that have spread beyond where they started or are difficult to treat with standard therapies.
Is RLY-4008 a chemotherapy drug?
No, it's a 'targeted therapy' which means it's designed to specifically attack certain parts of cancer cells, rather than all fast-growing cells like traditional chemotherapy.
What does Phase I and Phase II mean?
Phase I trials are about finding a safe dose and checking safety. Phase II trials see if the drug works for a specific type of cancer and continue to monitor safety.
Will I get paid to be in the study?
Usually, you won't be paid, but sometimes travel expenses to and from the clinic visits might be covered.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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