Tuvusertib (M1774) in Participants with Metastatic or Locally Advanced Unresectable Solid Tumors (DDRiver Solid Tumors 301)
This study is looking at an experimental drug called tuvusertib (also known as M1774) in adults with advanced solid tumours. A solid tumour is an abnormal mass of cancer cells in an organ or tissue. The trial is for people whose cancer has spread to other parts of the body (metastatic) or cannot be removed with surgery (unresectable). Because this is a Phase 1 clinical trial, it is one of the earliest stages of testing in humans. The main goal is not yet to prove how well the medicine shrinks tumours, but to find out if it is safe, what side effects it might cause, and what dose is best. Participants will receive close monitoring from a specialist cancer care team with regular blood tests, scans, and clinic visits throughout their treatment.
At a glance
What is this study about?
When cancer cells grow and divide quickly, they often rely on specific internal repair systems to fix damage to their genetic code. Tuvusertib (M1774) is a new type of targeted drug designed to disrupt these repair systems in cancer cells. By blocking these repair pathways, scientists hope the drug will cause cancer cells to become overwhelmed and die, while leaving healthy cells largely unharmed.
This trial is specifically for people with advanced solid tumours. These are cancers that form firm lumps in body organs—such as the bowel, lungs, or breasts—that have either spread elsewhere in the body or grown too deeply to be safely operated on. For many people in this situation, standard treatments may have already been tried or may no longer be working as well as hoped.
Because this is an early-phase trial, the primary aim is safety. The research team wants to understand how the drug moves through the body, what dose works best without causing severe side effects, and whether there are early signs that it can help control tumour growth. The findings will help doctors decide if tuvusertib should be tested in larger clinical trials in the future.
Key takeaways
- Tests an experimental cancer drug called tuvusertib (M1774).
- Open to adults aged 18 and over with advanced or metastatic solid tumours.
- A Phase 1 trial designed mainly to check safety and find the best dose.
- Requires frequent hospital visits, regular scans, and blood tests.
- Taking part is completely voluntary and you can stop at any time.
Who may be eligible?
This trial is open to adults aged 18 and over who have been diagnosed with an advanced or metastatic solid tumour. 'Metastatic' means the cancer has spread from where it first started to other parts of the body. 'Unresectable' means surgeons cannot safely take the tumour out with an operation.
To be considered, participants generally need to have tried standard NHS treatments first, or have a type of cancer for which no standard options exist. A specialist doctor will also need to check that your overall physical health, including your heart, liver, and kidneys, is strong enough to safely cope with a new medication.
People who are pregnant, breastfeeding, or dealing with other severe medical conditions may not be able to join. Your hospital doctor or oncologist can review your medical notes to see if this study could be an appropriate match 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 a solid tumour (such as lung, bowel, or breast cancer).
- My cancer has spread or cannot be removed with surgery.
- I am well enough to attend regular hospital appointments.
- I am open to trying an experimental treatment.
What does participation involve?
If you take part in this trial, you will be asked to visit a specialist hospital clinic regularly. At the start, you will have health checks, including blood tests, physical examinations, heart scans (ECGs), and imaging scans such as CT or MRI scans to check the size of your tumour. You will then receive the study medicine, tuvusertib, according to a set schedule. Because this is an early trial, clinic visits will be quite frequent at first so doctors can monitor your safety and check for side effects. You will continue taking the medicine for as long as your cancer remains stable and the side effects are manageable. Even after you finish taking the drug, the study team will keep in touch to see how you are feeling.
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 stages of testing a new medicine in people. Its main purpose is to test safety, discover side effects, and find the right dose.
Will taking part cost me anything?
No, the study medicine and all related tests are provided free of charge. Some trials also help cover travel expenses to and from the hospital.
What is an unresectable solid tumour?
It refers to a firm lump of cancer cells in an organ or tissue that cannot be completely removed using surgery, often because of its size or location.
Can I leave the trial if I change my mind?
Yes, you can leave the study at any point without giving a reason. Your doctors will continue to give you the best possible standard care.
Will this drug cure my cancer?
Early-phase trials cannot promise a cure. The main aim is to find out if the drug is safe and whether it can help control tumour growth.
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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