AuthorisedHuman Pharmacology (Phase I)- First administration to humansInterventional

AMG 436 as monotherapy and combination therapy in participants with Microsatellite Instability-High/Mismatch Repair Deficient Solid Tumors

This research is looking into a new medicine called AMG 436. It's for adults who have a specific type of advanced cancer, known as microsatellite instability-high or mismatch repair deficient (MSI-H/dMMR) solid tumours. This is a very early-stage study, called 'Phase I', meaning it's the first time this medicine is being given to people. The main aim is to find out if AMG 436 is safe and how it affects the body when given alone or with other treatments. It's hoped this research will help us understand if it could be a useful treatment in the future for these particular cancers.

At a glance

Status

Authorised

Phase

Human Pharmacology (Phase I)- First administration to humans

Sponsor

Amgen Inc.

Enrolment target

Start

28 Apr 2026

microsatellite instability high/mismatch repair deficient (MSI-H/dMMR) solid tumors

What is this study about?

This clinical trial is exploring a brand new medicine, AMG 436, for people who have certain types of advanced cancer. Specifically, it's for those with 'microsatellite instability-high' (MSI-H) or 'mismatch repair deficient' (dMMR) solid tumours. These are technical terms that describe certain features within cancer cells. When cancer cells have these features, it can sometimes mean they respond differently to treatments.

Because this is a very early-stage study, often called 'Phase I', the first step is to give the medicine to humans for the first time. The main goals are to check if AMG 436 is safe, what side effects it might cause, and how much of it the body can handle. Researchers will also look at how the medicine works within the body, both when given by itself and when combined with other treatments.

The information gathered from this study is really important. It helps doctors understand if AMG 436 has the potential to become a helpful treatment option for people with these specific advanced cancers in the future. It's a careful step-by-step process to ensure new medicines are safe and potentially effective.

Key takeaways

This study is testing a completely new medicine, AMG 436.
It's for people with specific advanced cancers (MSI-H/dMMR solid tumours).
The main goals are to check the medicine's safety and how it works.
It's a very early-stage (Phase I) human trial.
Participants will receive the new medicine either alone or in combination.
You can stop participating at any time.

Who may be eligible?

This study is looking for adults aged 18 or older. Both men and women can take part. Everyone joining the study must have been diagnosed with a specific kind of advanced cancer called microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) solid tumours.

There might be other health conditions or treatments that could prevent someone from joining, as the researchers need to make sure it's safe for everyone involved. For example, you might not be able to join if you have certain other serious medical problems.

Because this is an early study, participants usually need to be well enough to take part and attend regular appointments. Your doctor will be able to tell you more about whether this study might be suitable 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.

Are you 18 years old or older?
Do you have a diagnosis of advanced MSI-H/dMMR solid tumour?
Are you able to travel to study appointments?
Are you willing to have regular medical checks, including blood tests and scans?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would receive the new medicine, AMG 436, either on its own or together with other treatments. This would involve regular visits to the hospital or clinic for treatments and check-ups. During these visits, doctors and nurses would perform various assessments, such as blood tests, scans, and physical examinations, to monitor your health and how the medicine is affecting you.

Participation would involve a treatment period, followed by a time where researchers would carefully follow up on your health. The total time you would be involved in the study can vary, and this will be explained fully to you before you make any decisions. All appointments and procedures would be clearly communicated.

Potential risks and benefits

Taking part in an early-stage study like this means you might be among the first to receive a new medicine, which could potentially help your condition if current treatments aren't working well. However, because it's a new medicine, there are also potential risks, including unknown side effects that researchers are carefully monitoring. You would be closely watched by the medical team to manage any side effects. Remember, you can choose to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (3)

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

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Unverified
Spain
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Unverified
France
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Unverified
Belgium

Common questions

What does 'Microsatellite Instability-High/Mismatch Repair Deficient' (MSI-H/dMMR) mean?

These are specific features that doctors look for in cancer cells. They can sometimes tell us if the cancer might respond to certain new treatments.

What does 'Phase I' mean for a clinical trial?

Phase I means it's the very first time a new medicine is being given to people. The main aim is to check its safety and how it works in the body.

Will I definitely get the new medicine if I join?

Yes, in this type of study, all participants who meet the requirements would receive the new medicine, AMG 436, either alone or with other treatments.

How long would I be in the study?

The exact length of time varies for each person. The study team will explain the expected duration of treatment and follow-up before you decide to join.

Can I leave the study at any time?

Yes, you are free to leave the study at any point, for any reason, and your decision will not affect your ongoing medical care.