A phase 1/1b/2 study evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of AMG 193 alone and in combination with docetaxel in subjects with advanced MTAP-null solid tumors
This early-stage clinical trial is studying a new drug called AMG 193. It is designed for adults with advanced solid tumours that have a specific genetic feature known as 'MTAP-null'. When cancer cells lose the MTAP gene, it creates a weakness that targeted medicines might be able to attack. Because this is one of the first times AMG 193 is being tested in humans, doctors want to find out how safe it is, what side effects it causes, and what dose works best. The trial tests AMG 193 on its own and also in combination with a standard chemotherapy drug called docetaxel. Doctors will closely track whether the treatment helps shrink tumours or stops them from growing. Taking part involves regular hospital visits, blood tests, and scans to keep a close eye on your health.
At a glance
What is this study about?
Solid tumours are cancers that form in organs or tissues, such as the lungs, pancreas, or bladder. In some people, these tumour cells are missing a gene called MTAP. Scientists have discovered that losing this gene makes cancer cells vulnerable to specific targeted drugs, while healthy cells remain largely protected. AMG 193 is an experimental medicine created to take advantage of this exact weakness.
This study is an early-phase trial, meaning it is one of the first times AMG 193 has been given to people. The main aim is to understand how the human body handles the drug, what side effects it might cause, and what dose is safe and tolerable. Researchers are testing AMG 193 on its own, as well as paired with docetaxel, an established chemotherapy medicine already used for several types of cancer.
As the study progresses, doctors will also measure whether the treatment helps shrink tumours, slows down cancer growth, and improves how long people live with their condition. Clinical trials like this are vital for discovering whether newer, more tailored therapies can offer hope to patients when standard cancer treatments are no longer working well.
Key takeaways
- Testing a new targeted drug called AMG 193 for advanced solid tumours.
- Only suitable for tumours that have been tested and found to lack the MTAP gene.
- Tests AMG 193 alone and alongside a common chemotherapy drug called docetaxel.
- Aims to check the drug's safety, side effects, and ability to shrink tumours.
- Involves regular hospital visits, blood tests, heart checks, and scans.
Who may be eligible?
This trial is open to adults aged 18 and over who have an advanced solid tumour. 'Advanced' means the cancer may have spread to other parts of the body or cannot be completely removed with surgery.
To be considered, your tumour must be 'MTAP-null'. This means laboratory tests on a sample of your tumour have confirmed that the cancer cells lack the MTAP gene. Your cancer specialist can review your previous biopsy results or arrange a test to check for this genetic marker.
Because this is an early-stage study, you will also need to be reasonably active and well enough to attend regular hospital appointments. Your doctor will check that your heart, liver, and kidneys are working well enough for you to safely receive the study treatment.
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 an advanced or spreading solid tumour.
- My cancer has been tested (or can be tested) for the MTAP-null marker.
- I am well enough to travel to hospital for regular visits and tests.
- I am willing to undergo blood tests, heart checks, and regular scans.
What does participation involve?
If you take part, you will be treated at a specialist hospital clinic. You will take the study drug AMG 193, and depending on which group you join, you may also receive docetaxel chemotherapy through a drip into your vein. Throughout the trial, you will have frequent health checks, including physical exams, blood tests, heart traces (ECGs), and imaging scans such as CT or MRI scans. These tests help doctors watch for side effects and see how your tumour is responding. You will usually stay on the trial as long as the treatment is helping you and the side effects remain manageable. You can stop taking part at any time.
Potential risks and benefits
Locations (4)
- —UnverifiedBelgium
- —UnverifiedGermany
- —UnverifiedAustria
- —UnverifiedFrance
Common questions
What does 'MTAP-null' mean?
It means your cancer cells are missing a specific gene called MTAP. Doctors can check for this using a sample of your tumour tissue taken during a biopsy.
Is AMG 193 a chemotherapy drug?
No, AMG 193 is a targeted therapy. It is designed to attack a specific weakness found only in cancer cells that lack the MTAP gene, rather than affecting all fast-growing cells.
Will I have to pay to take part?
No. In the UK, clinical trial medicines and study-related tests are provided free of charge, and some trials may help cover travel expenses.
Can I carry on taking my usual medicines?
Most routine medicines are fine, but some drugs can interfere with the study treatment. The research team will review all your medications to ensure they are safe to take together.
What happens if the treatment stops working?
If scans show your cancer is growing or if side effects become too difficult, the study team will stop the trial medicine and discuss other standard care options with you.
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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