A Phase 1/2 open-label, multicenter study of oral GSK5460025 alone or in combination with other anti-cancer agents in adult participants with Mismatch Repair-deficient (dMMR) or Microsatellite Instability-High (MSI-H) solid tumors.
This study is for adults who have solid cancers, including bowel cancer, which have specific genetic changes (called dMMR or MSI-H). Researchers are investigating a new oral medicine called GSK5460025. This medicine will be tested both on its own and in combination with other existing cancer treatments. The main goals are to find out if the new medicine is safe, what the right dose is, and if it can help shrink the cancer. This is an early-stage study, meaning it’s one of the first times this medicine is being tested in humans.
At a glance
What is this study about?
This study is looking into a new medicine called GSK5460025 for adults who have certain types of solid tumours, which are often found in bowel cancer but can occur elsewhere. These cancers have specific genetic features that doctors refer to as 'Mismatch Repair-deficient' (dMMR) or 'Microsatellite Instability-High' (MSI-H). If you or someone you know has been diagnosed with cancer, your doctors might already have checked for these features.
The study is split into two main parts. In the first part, the researchers are trying to find the safest and most effective dose of GSK5460025. They will carefully watch for any side effects and how participants react to different doses. In the second part, once a safe dose is found, the study will focus on how well the medicine works. This includes seeing if the medicine can shrink the tumours or stop them from growing.
The medicine is taken by mouth, either on its own or together with other well-known cancer drugs. This is an early stage clinical trial (Phase 1/2), which means it's among the first times this new medicine is being tested in people. This type of research is really important for developing new cancer treatments.
Key takeaways
- The study is for adults with specific solid tumours (dMMR or MSI-H).
- It's testing a new oral medicine called GSK5460025.
- The medicine may be given alone or with other treatments.
- The main goals are to find a safe dose and see if the medicine helps shrink cancer.
- Participation involves regular clinic visits for monitoring and tests.
Who may be eligible?
To join this study, you must be an adult, aged 18 years or older. There is no upper age limit.
The study is specifically for people with solid tumours, which means cancers that form a lump or mass of tissue, like bowel cancer. Crucially, your cancer must have certain genetic markers that doctors check for, known as 'Mismatch Repair-deficient' (dMMR) or 'Microsatellite Instability-High' (MSI-H).
Both men and women can take part in this study. Other specific medical conditions or treatments you're currently receiving might affect whether you can join, but your doctor will check all of these details with 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 18 years old or older?
- Do you have a solid tumour diagnosis?
- Has your doctor told you your cancer is 'dMMR' or 'MSI-H'?
- Are you able to take medicine by mouth?
What does participation involve?
If you decide to take part in this study, you will be given the new medicine, GSK5460025, by mouth. This might be on its own or alongside other cancer treatments. You will have regular visits to the clinic so the medical team can monitor your health closely. These visits will involve various checks, including blood tests, heart scans (ECGs), and measurements of your vital signs like blood pressure and temperature.
The team will carefully check for any side effects you might experience and how your body is handling the medicine. They will also do scans to see if your cancer is responding to the treatment. The total length of your participation will depend on how you respond to the treatment and the study plan, but it will involve ongoing check-ups and monitoring.
Potential risks and benefits
Locations (6)
- —UnverifiedItaly
- —UnverifiedDenmark
- —UnverifiedSpain
- —UnverifiedSweden
- —UnverifiedNetherlands
- —UnverifiedFrance
Common questions
What kind of cancer is this study for?
This study is for adults with solid tumours that have specific genetic changes called dMMR or MSI-H, which is often found in bowel cancer.
What is GSK5460025?
It's a new medicine being tested to see if it can help treat these types of cancer. It's taken by mouth.
What are 'dMMR' and 'MSI-H'?
These are genetic features of certain cancers that doctors can test for. They indicate how the cancer cells might respond to certain treatments.
Will I get this medicine on its own?
It might be given on its own or in combination with other existing cancer treatments, depending on the study's plan for you.
What does a 'Phase 1/2' study mean?
It means this is an early study to first check the safety and right dose of a new medicine, and then see how well it works.
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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