Ongoing, recruitingPhase I and Phase II (Integrated)- OtherInterventional

A Phase 1/2 Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of AMG 193 in Combination With IDE397 in Subjects With Advanced MTAP-null Solid Tumors

This research is testing two medications, AMG 193 and IDE397, for people with advanced solid cancers that are missing a gene called MTAP. The study is split into two parts. In the first part, the main goal is to find out if the medicines are safe and what side effects they might cause. Doctors will closely watch for any reactions and check body functions like blood pressure and heart rate. In the second part, the focus shifts to whether the medicines can make the cancer shrink or stop growing, particularly in a type of lung cancer. Researchers will use scans like CT or MRI to measure how the tumours respond. The study will also look at how these medicines move through the body and how long any positive effects last.

At a glance

Status

Ongoing, recruiting

Phase

Phase I and Phase II (Integrated)- Other

Sponsor

Amgen Inc.

Enrolment target

Start

08 Jul 2024

In Part 1 subjects with advanced MTAP-null solid tumors and in Part 2 subjects with advanced MTAP-null Non Small-Cell Lung Cancer

What is this study about?

This research is investigating two new potential medicines, AMG 193 and IDE397, for people who have advanced solid cancers that are missing a gene known as MTAP. This particular gene is important, and its absence can sometimes make cancer harder to treat. Doctors hope these new treatments might be more effective for this specific type of cancer.

The study has two main stages. The first stage is all about safety. Researchers will start with small doses of the medicines and slowly increase them while carefully watching for any side effects. They'll regularly check participants' health, including blood tests, heart readings, and blood pressure, to make sure the medicines are as safe as possible. This part helps them find the right amount of medicine to give without causing too many problems.

The second stage focuses on whether the medicines actually help the cancer. For this part, the study will mainly look at people with a specific type of advanced lung cancer, called non-small cell lung cancer, that also has the missing MTAP gene. Doctors will use scans like CT or MRI to see if the tumours shrink, stop growing, or completely disappear after treatment. They will also keep track of how long any good effects last and closely monitor for any new side effects throughout the study. This helps them understand if the medicines are not only safe but also effective in fighting this type of cancer.

Key takeaways

This study is for advanced solid cancers, specifically those missing the 'MTAP' gene.
It's testing two new medicines, AMG 193 and IDE397, in combination.
The initial part focuses on safety and finding the right dose.
The later part investigates if the medicines can shrink tumours, especially for a type of lung cancer.
Close medical monitoring, including scans and blood tests, will be part of participation.
You can stop participating at any time.

Who may be eligible?

To be considered for this study, you must be at least 18 years old. Both men and women are welcome to take part.

The study is specifically for people who have advanced solid cancers where their cancer cells are missing a gene called MTAP. In the second part of the study, the focus narrows to people with a specific type of advanced lung cancer (non-small cell lung cancer) that also has this missing MTAP gene.

There might be other health requirements or previous treatments that could affect whether you can join. These details would be discussed with you by the study team.

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 solid cancer?
Has your doctor confirmed that your cancer cells are missing the MTAP gene?
If you have lung cancer, is it a type called 'non-small cell lung cancer' and is it advanced?
Are you able to attend regular clinic visits for checks and treatments?

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 medicines, AMG 193 and IDE397. These will likely be given over a period of time, possibly through injections or infusions, but the exact method would be explained in detail.

Throughout the study, you would have regular visits to the clinic. These visits would include check-ups by the doctors, blood tests to monitor your health and how the medicines are affecting your body, and scans like CT or MRI to see how your cancer is responding. There might also be heart trace tests (ECGs) to check your heart.

The total length of the study would be explained to you, but typically, these types of studies involve consistent treatment cycles followed by monitoring. You would be closely supported by the study team throughout your participation.

Potential risks and benefits

Taking part in any clinical study carries potential benefits and risks. A potential benefit of this study is that these new medicines might help to shrink your cancer or slow its growth, especially if current treatments haven't worked well. However, there's no guarantee the medicines will be effective for you. Potential risks include experiencing side effects from the medicines, which could range from mild to more serious and might require extra medical care. Your safety will be closely monitored by the study team. Remember, you can choose to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (2)

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
Denmark

Common questions

What does 'advanced solid tumors' mean?

It means the cancer has spread from where it started to other parts of the body.

What does 'MTAP-null' mean?

It means the cancer cells are missing a specific gene called MTAP. This study is testing medicines designed for cancers with this particular missing gene.

What is the difference between 'Phase 1' and 'Phase 2'?

Phase 1 studies mainly check if a new medicine is safe and find the right dose. Phase 2 studies then look at whether the medicine works to treat the disease.

Will I know if the medicine is working for me?

The study doctors will use scans like CT or MRI to track your cancer and will discuss your results with you over time.

What are 'side effects'?

Side effects are any unwanted reactions or problems caused by a medicine. The study will carefully monitor you for these.