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Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

Study of tuvusertib (M1774) in combination with DNA Damage Response Inhibitors or Immune Checkpoint Inhibitors

This research study is investigating a new medication, tuvusertib (M1774), in adults with advanced solid cancers. These are cancers that have either spread to other parts of the body (metastatic) or are too large or in a difficult place to be removed by an operation (locally advanced unresectable). This is an early phase study, meaning researchers are primarily focused on understanding how the drug works in the body, checking its safety, and finding the right dose. They also want to see if tuvusertib can be effectively combined with other types of cancer treatments, such as those that repair DNA damage or those that boost the body’s own immune system to fight cancer. The overall aim is to explore new ways to treat these challenging cancers.

At a glance

Status
Ongoing, recruiting
Phase
Human Pharmacology (Phase I)- Other
Sponsor
Merck Healthcare KGaA
Enrolment target
33
Start
01 Sep 2022

What is this study about?

This research study is focused on a new drug called tuvusertib, also known as M1774, for people living with certain types of advanced solid cancers. 'Solid cancers' are those that form a lump or tumour, like breast cancer, lung cancer, or bowel cancer, as opposed to blood cancers. When we say 'advanced', it means the cancer has either spread to other parts of the body (this is called metastatic cancer) or it's grown in a way that makes it impossible to remove with surgery locally.

The main goal of this study is to understand more about tuvusertib. It's a very early-stage study, sometimes called a Phase I study. This means the researchers are mainly looking at how the drug behaves in the human body – how it's absorbed, distributed, and removed. Importantly, they are also carefully checking for any side effects and trying to find the safest and most effective dose. Think of it like taking the first careful steps with a new medicine.

Another key part of this study is to see if tuvusertib can be given alongside other existing cancer treatments. Specifically, they are interested in combining it with drugs that target 'DNA damage response' – these are drugs that interfere with how cancer cells repair themselves, making them more vulnerable. They also want to see how it works with 'immune checkpoint inhibitors', which are medicines that help your own immune system recognise and attack cancer cells. By combining treatments, sometimes doctors can achieve better results than with one treatment alone, and this study aims to explore those possibilities.

Key takeaways

  • This study is testing a new cancer drug called tuvusertib (M1774).
  • It's for adults with advanced solid cancers that have spread or can't be operated on.
  • It's an early-stage study to check safety and find the right dose.
  • Researchers want to see if tuvusertib works well with other cancer treatments.
  • Taking part involves regular hospital visits, tests, and receiving study medication.
  • You can stop participating at any time.

Who may be eligible?

To be able to join this study, you generally need to be an adult, aged 18 years or older. This study is open to both men and women.

It's for people who have been diagnosed with solid cancers that are considered 'advanced'. This means your cancer has either spread to other parts of your body (metastatic) or it's located in a way that surgery to remove it isn't possible (locally advanced unresectable).

There will be other, more detailed health checks and requirements that your doctor will discuss with you to make sure the study is safe and appropriate for your specific situation. These might include past treatments you've had, other health conditions, and certain blood test results.

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.

  1. Are you 18 years old or older?
  2. Do you have a solid cancer (e.g., breast, lung, bowel) that has spread or can't be removed by surgery?
  3. Are you able to attend regular hospital visits and appointments?
  4. Are you able to understand and consider the information about the study?
Answer every question to see your result.

What does participation involve?

Taking part in this study would involve regular visits to the hospital or clinic. During these visits, you would have medical check-ups, blood tests, and scans to monitor your health and how the treatment is working. You would receive the study drug, tuvusertib, and potentially another cancer treatment as part of the study plan. The exact number of visits, tests, and how long each treatment cycle lasts would be carefully explained by the study team. After the main treatment, there would likely be follow-up visits or contact to continue monitoring your health, even after you stop taking the study drugs. The total duration of your participation, including follow-up, would be made clear to you before you agree to join.

Potential risks and benefits

While there's no guarantee that participating in this study will directly benefit your cancer, you might receive a new treatment that isn't widely available yet, which could help your condition. Your participation will also help doctors learn more about this drug and how to treat cancer in the future, potentially helping many others. However, like all medicines, tuvusertib and the combination treatments can cause side effects. These could range from mild to more serious, and the study team will monitor you closely for any issues. You are absolutely free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • Unverified
    Spain

Common questions

What kind of cancers is this study for?

This study is for adults with solid cancers that have spread (metastatic) or can't be removed by surgery (locally advanced unresectable).

What is tuvusertib (M1774)?

Tuvusertib (M1774) is a new drug being tested in this study. It's designed to treat cancer, and researchers are trying to learn more about how it works and if it's safe.

What does 'Phase I' mean?

Phase I means it's an early study, mainly focused on checking the drug's safety, how it behaves in the body, and finding the right dose, rather than how well it treats the cancer at this stage.

Will I get other treatments with tuvusertib?

Yes, the study is looking at tuvusertib in combination with other existing cancer medicines, specifically those linked to DNA repair or boosting your immune system.

Can I leave the study if I change my mind?

Yes, you have the right to withdraw from the study at any time, for any reason, without it affecting your normal medical care.

How to find out more

Always speak to your GP or specialist before deciding to take part in a study.

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