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AuthorisedHuman Pharmacology (Phase I)- First administration to humansInterventional

Anti-Ly6E Exatecan ADC M7437 in Advanced Solid Tumors

This research study is looking at a new experimental medicine called M7437 for people who have advanced solid tumours. Advanced solid tumours are cancers that started in an organ like the lung or bowel, and have then spread to other parts of the body. This is a very early-stage study, meaning it's the first time this new medicine is being given to people. Doctors want to understand if it's safe, what dose works best, and how the body handles it. They hope this medicine could offer a new treatment option for people whose cancers are hard to treat with current therapies. The study is open to adults aged 18 and over.

At a glance

Status
Authorised
Phase
Human Pharmacology (Phase I)- First administration to humans
Sponsor
Merck Healthcare KGaA
Enrolment target
14
Start
03 Mar 2026

What is this study about?

This study is exploring a new potential treatment called M7437 for advanced solid tumours. 'Advanced' means the cancer has spread from where it started to other areas of the body, and 'solid tumours' refer to cancers that form a lump, rather than blood cancers like leukaemia. This new medicine is designed to target specific cancer cells. It's an experimental treatment, which means it's not yet approved for general use but is being carefully studied.

This is a 'Phase I' study, which is the earliest stage of human trials. The main goal at this stage is to find out if the medicine is safe for people, how much of it can be given without causing serious side effects, and how it behaves in the body. It's also important to see if there are any early signs that the medicine might be effective against cancer. Because it's so early, it's not guaranteed to have benefits, but it's a crucial step in developing new treatments.

The research aims to gather important information that will help doctors decide if M7437 should be tested in larger studies with more people. If successful, studies like this pave the way for new treatment options for cancers that are currently very challenging to treat. Participants will be closely monitored by a medical team to ensure their safety and well-being throughout the study.

Key takeaways

  • This study tests a new medicine (M7437) for advanced solid tumours.
  • It's a very early-stage (Phase I) study, aiming to check safety and how the body handles the medicine.
  • Participants must be 18 or older and have advanced solid tumours.
  • You'll have regular hospital visits, tests, and receive the study medicine.
  • There might be benefits, but also risks like side effects, which will be explained.
  • You can stop participating at any time.

Who may be eligible?

To join this study, you must be at least 18 years old – there's no upper age limit. Both men and women can take part. The study is for people who have advanced solid tumours, which means their cancer has spread.

There might be other specific health requirements or conditions that would prevent someone from joining, even if they meet the age and cancer type criteria. These could relate to other medical conditions you have, medicines you are currently taking, or how well certain organs like your kidneys or liver are working.

The research team will carefully review your full medical history and perform some tests to determine if this study is suitable and safe for you. It's important to be open and honest about your health so they can make the best decision for your safety.

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 advanced solid tumours (cancer that has spread)?
  3. Are you able to attend regular hospital appointments?
  4. Are you willing to follow the study's treatment and testing schedule?
  5. Are you willing to tell the study team about all your current health conditions and medicines?
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 and urine tests, and possibly scans to monitor your health and how the medicine is affecting your body and cancer. You would receive the study medicine, M7437, according to a specific schedule decided by the doctors. This would involve regular doses, which might be given as an injection or infusion.

Throughout the study, you would be closely monitored for any side effects or changes in your health. You would also have follow-up visits after stopping the medicine to make sure you are recovering well and to collect final information. The total length of your participation would depend on how your body responds to the medicine and if you experience any side effects, but it will be thoroughly explained to you before you agree to join.

Potential risks and benefits

As with any new medicine, there are potential benefits and potential risks. The main potential benefit is that M7437 might help to control or shrink your cancer, or slow its growth, especially if other treatments haven't worked well. However, because this is a very early-stage study, it's also possible that you may experience no direct benefit from taking part. Potential risks include side effects from the study medicine, which could range from mild to serious, similar to other cancer treatments. The research team will explain all known and potential side effects to you. It's very important to remember that you have the right to withdraw from the study at any time, for any reason, without it affecting your future 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 does 'advanced solid tumours' mean?

It means the cancer started in an organ (like the lung or bowel) and has spread to other parts of your body.

What is a 'Phase I' study?

It's the very first time a new medicine is given to people. Doctors check if it's safe and how it works in the body.

Will this medicine cure my cancer?

It's too early to say. Phase I studies mostly check safety. Any benefits for cancer control are a bonus at this stage.

Will I have to pay anything to be in the study?

No, all study-related treatments and tests are provided at no cost to you.

Can I leave the study if I change my mind?

Yes, you can withdraw from the study at any time, for any reason, without affecting your 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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