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Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

M9466 in Combination with Topoisomerase 1 Inhibitors-based Regimens in Advanced Solid Tumors and Colorectal Cancer (DDRiver 511)

This research study is looking at a new treatment, called M9466, when given together with existing cancer medicines. It's for people who have advanced solid tumours (which are cancers that form a lump or growth) or advanced bowel cancer. This is a very early-stage study, known as Phase 1, which means the main aim is to understand how safe the new treatment is, how much of it people can take, and how it behaves in the body. Researchers are hoping to find out if this new combination could be a useful way to treat these cancers in the future. Everyone taking part must be aged 18 or over.

At a glance

Status
Ongoing, recruiting
Phase
Human Pharmacology (Phase I)- Other
Sponsor
Merck Healthcare KGaA
Enrolment target
14
Start
21 Oct 2024

What is this study about?

This study is investigating a new medicine, which we'll call M9466 for now. It's being tested in people who have advanced solid tumours (cancers that form a lump) or advanced bowel cancer. The word 'advanced' means the cancer may have spread from where it started.

The researchers want to see how M9466 works when it's given together with other standard cancer medicines that are already being used. This includes medicines that affect something in cancer cells called Topoisomerase 1. The main goal of this particular study is to learn about the safety of M9466 and to understand how it acts in the human body. This type of early study is important for finding out if a new medicine has potential and how much of it can be safely given.

By taking part in studies like this, patients help doctors learn more about new ways to fight cancer. While this study isn't designed to find a cure, it’s a crucial step in developing future treatments. The information gathered will help design larger studies later on, to see if M9466 can effectively treat these cancers.

Key takeaways

  • This study is for people with advanced solid tumours or advanced bowel cancer.
  • It's testing a new medicine called M9466 combined with existing cancer treatments.
  • The main aim is to check the safety of M9466 and how it works in the body.
  • Participants must be aged 18 or over.
  • This is an early-stage study, helping to pave the way for potential future treatments.

Who may be eligible?

To be able to take part in this study, you must be at least 18 years old. People of any sex are welcome to join.

This study is specifically for individuals who have been diagnosed with advanced solid tumours or advanced bowel cancer. Advanced cancer means the cancer may have spread within the body.

There will be other detailed health requirements that your doctor will check to make sure the study is safe and suitable for you. These might include details about your general health, other medical conditions you have, and any previous treatments you’ve had.

Quick self-check
  • Are you 18 years old or older?
  • Do you have a diagnosis of advanced solid tumours or advanced bowel cancer?
  • Are you generally well enough to take part in a clinical study?
  • Have you discussed this study with your cancer specialist?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part, the study team will explain everything in detail. You will likely have regular visits to the hospital for check-ups, blood tests, and scans. This is to monitor your health and see how the treatment is working. You will receive the study medicine, M9466, along with other standard cancer treatments as decided by the study doctors. The exact schedule of visits and treatments will vary, but the study team will make sure you understand it completely before you start. You'll be closely monitored throughout the study, and there will be follow-up appointments after your treatment finishes to see how you're doing.

Potential risks and benefits

Taking part in a clinical study means you might be among the first to receive a new treatment, which could potentially help you. However, there's no guarantee the treatment will work, and it might not directly benefit you. As with all medicines, there can be side effects, and some may be serious or unexpected. The study team will explain all known possible side effects. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

  • Spain

Common questions

What is a 'solid tumour'?

A solid tumour is a type of cancer that forms a lump or growth in the body, unlike blood cancers like leukaemia.

What does 'advanced' cancer mean?

Advanced cancer means the cancer has spread beyond where it started to other parts of the body.

What is a Phase 1 study?

A Phase 1 study is an early stage of clinical research. Its main goal is to find out if a new medicine is safe, find the right dose, and see how the body handles it.

Will I know if I'm getting M9466?

Yes, in this type of study, you'll know if you're receiving the new medicine M9466 along with standard treatment.

Who can I speak to if I have more questions?

You should speak to your doctor or the study team, who can provide more detailed information and answer all your questions.

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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