M9466 Alone or in Combination in Advanced Solid Tumors (DDRiver 501)
This clinical trial, called DDRiver 501, is looking at an experimental cancer medicine known as M9466. It is designed for adults who have advanced solid tumours—cancers that form solid lumps and may have grown or spread after other treatments. Because this is a Phase 1 trial, doctors are testing M9466 in people to see how safe it is and how well the body handles it. They want to find the right dose and understand any side effects. In some groups of patients, M9466 will be given by itself, while in others it may be combined with other cancer medicines. Participants will need to visit the hospital regularly for health checks, blood tests, and scans. Early trials help doctors learn whether new treatments could become helpful options in the future. Taking part is completely voluntary, and you can stop at any time.
At a glance
What is this study about?
Solid tumours are cancers that develop in organs, bones, or tissues, such as the lungs, bowel, or breasts. When a tumour is described as 'advanced', it means the cancer has grown locally or spread to other parts of the body, and standard treatments may no longer be keeping it under control. Researchers are constantly searching for new ways to target and treat these cancers.
This study is testing an investigational drug called M9466. It belongs to an early phase of research known as Phase 1. In Phase 1 studies, the primary focus is not yet on how well the drug cures the disease, but on finding out whether it is safe for people to take. Doctors want to see what happens to the drug inside the human body, what side effects it might cause, and what the highest safe dose is.
The trial tests M9466 in two ways: on its own, and in combination with other established cancer therapies. By combining treatments, doctors hope to see if M9466 can make other medicines work better against cancer cells. The knowledge gained from this study will help scientists decide if M9466 should be tested in larger, later-stage clinical trials.
Key takeaways
- DDRiver 501 is a Phase 1 trial testing a new cancer medicine called M9466.
- It is for adults with advanced solid tumours who have limited standard treatment options.
- The main goals are to find a safe dose and learn about possible side effects.
- M9466 is being tested both alone and in combination with other treatments.
- Taking part involves close monitoring through regular hospital visits, scans, and blood tests.
Who may be eligible?
This trial is open to adults aged 18 and over who have an advanced solid tumour. It is generally aimed at people whose cancer has returned or continued to grow after standard cancer therapies, or those for whom standard treatments are no longer suitable.
Because this is an early-phase trial testing a new medicine, participants must be reasonably well in their day-to-day life and have organs (such as the heart, liver, and kidneys) that are working well enough to safely process the drug.
You may not be eligible if you have certain other serious medical conditions, active infections, or if you are pregnant or breastfeeding. The study team will review your full medical history and perform tests to check if joining is safe 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.
- I am aged 18 or older.
- I have been diagnosed with an advanced solid tumour.
- My cancer has continued to grow despite standard treatments, or suitable standard treatments are not available.
- I am well enough to carry out everyday activities.
- I am willing and able to attend regular hospital appointments for tests and treatment.
What does participation involve?
If you take part, you will receive the study medicine M9466 either by itself or alongside another cancer drug. Your care team will explain how the medicine is given (for example, as a tablet or through a drip into a vein) and how often you need to take it. You will need to attend regular hospital visits for safety checks, which will include physical examinations, blood tests, heart checks (ECGs), and imaging scans such as CT or MRI scans. Because this is a Phase 1 study, visits may be quite frequent at first so the team can monitor you closely. You will usually stay on the trial as long as the treatment is helping and the side effects are manageable, followed by a check-up period after treatment finishes.
Potential risks and benefits
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Common questions
What is a Phase 1 clinical trial?
A Phase 1 trial is one of the earliest steps in testing a new drug in humans. Its main purpose is to check safety, find the best dose, and see how the body handles the medicine.
Will this trial cure my cancer?
Phase 1 trials are designed to test drug safety rather than guarantee a cure. While researchers hope the medicine will help slow or stop tumour growth, there is no guarantee it will do so.
Do I have to pay to take part?
No, you do not pay for trial treatments in the UK. The study medicine and all trial tests are provided free of charge, and some trials help cover travel expenses.
Can I leave the study if I change my mind?
Yes. You have the right to leave the study at any time, for any reason, without giving an explanation. Your standard NHS care will continue as normal.
How often will I need to visit the hospital?
Visits are usually more frequent during the first few weeks to carefully monitor your safety. The trial team will give you a clear schedule before you agree to join.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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