RecruitingPHASE1INTERVENTIONAL

AMG 410 Alone and in Combination With Other Agents in Participants With KRAS Altered Advanced or Metastatic Solid Tumors

This study is testing a new medicine called AMG 410 for people with advanced solid tumours that have a specific genetic change called KRAS. This is the first time this medicine is being given to people. The main goals are to find out if AMG 410 is safe, how well people tolerate it, and how it moves through the body. Researchers will also check if it helps to control the cancer, both when given by itself and when combined with other existing medicines like Pembrolizumab and Panitumumab. We need to find the right dose that works best with the fewest side effects.

At a glance

Status

Recruiting

Phase

PHASE1

Sponsor

Amgen

Enrolment target

434

Start

31 Jul 2025

Estimated completion

20 Apr 2031

KRAS Altered Advanced or Metastatic Solid Tumors

What is this study about?

This study is exploring a new medicine named AMG 410, designed for people who have advanced cancer where the cancer has a particular genetic feature called a KRAS alteration. This means there's a specific change in the KRAS gene within the cancer cells. This is important because such changes can make cancer hard to treat with standard therapies. The trial aims to understand how safe this new medicine is, how the body handles it, and if it can help slow down or shrink these types of tumours.

We'll be testing AMG 410 in two ways: first, by itself, and then by combining it with other established cancer medicines like Pembrolizumab and Panitumumab. The study will start by giving different dose levels to a small group of people to find the safest and most effective amount to give. Once we find this 'sweet spot' for the dose, more people may join to further understand its effects on different types of KRAS-altered cancers.

Knowing more about AMG 410 could lead to new treatment options for people whose cancers have this specific KRAS change. The information gathered will be crucial in deciding if this medicine should be studied in larger trials, potentially bringing a new way to fight these advanced cancers.

Key takeaways

This study is testing a new cancer medicine, AMG 410, for KRAS-altered advanced solid tumours.
It's a 'first-in-human' study, focusing on safety, how the body handles the medicine, and finding the best dose.
AMG 410 will be tested both on its own and in combination with other existing cancer treatments.
Participants must have advanced cancer with a specific KRAS gene change and limited other treatment options.
You can discuss with the study team if it's the right choice for you and withdraw at any time.

Who may be eligible?

To join this study, you must be 18 years or older and have a type of advanced cancer with a KRAS gene change. This change must be confirmed by a doctor. It's for people whose regular treatments aren't working, or who have chosen not to have them.

You need to be generally well enough to take part, able to swallow pills, and your organs (like your liver and kidneys) must be working properly. We'll also need a recent biopsy sample of your cancer tissue; if you don't have one, you might need a new biopsy.

There are also reasons why you might not be able to join. For example, if you have untreated brain tumours that are causing symptoms, certain heart or blood clot problems, an active serious infection, or have had other cancers recently. Also, if you've recently had other cancer treatments or certain vaccines, or have specific viral infections like HIV or Hepatitis, you might not be eligible.

Quick self-check

Are you 18 years old or older?
Does your cancer have a confirmed KRAS gene change?
Are standard treatments for your cancer no longer working, or have you decided not to have them?
Can you swallow pills and are you generally well enough to take part?
Do you have an existing tissue sample (biopsy) of your cancer, or are you willing to have a new one?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to join this study, you will take the study medicine, AMG 410, by mouth (as a pill). Some participants will take AMG 410 on its own, while others will take it with other approved cancer medicines. You will have regular visits to the clinic so the doctors can check how you are doing, monitor for any side effects, and see how the medicine is affecting your cancer. These visits will include various tests, blood samples, and scans. You will continue to receive the treatment until your cancer starts to grow again, you experience side effects that are too difficult to manage, or you decide to stop. The treatment period can last up to three years.

Potential risks and benefits

Participating in this study might offer a potential benefit by giving you access to a new medicine that could help control your cancer, especially if standard treatments haven't worked or aren't suitable. However, as with any new medicine, there are potential risks, including unknown side effects or that the treatment might not work for you. The study team will carefully monitor you for any side effects and will explain all known risks. Remember, you can choose to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (27)

City of Hope National Medical Center
Duarte, United States· Recruiting
Emory University
Atlanta, United States· Recruiting
Massachusetts General Hospital
Boston, United States· Recruiting
Siteman Cancer Center - Washington University
St Louis, United States· Recruiting
Duke Cancer Center
Durham, United States· Recruiting
Thomas Jefferson University
Philadelphia, United States· Recruiting
Sarah Cannon Research Institute Oncology Partners
Nashville, United States· Recruiting
Next Oncology
San Antonio, United States· Recruiting
Next Virginia
Fairfax, United States· Recruiting
Chris OBrien Lifehouse
Camperdown, Australia· Recruiting
The Queen Elizabeth Hospital
Woodville South, Australia· Recruiting
Peter MacCallum Cancer Centre
Parkville, Australia· Recruiting

+15 more sites — see the official record for the full list.

Common questions

What is a 'KRAS alteration'?

It's a specific change in a gene inside your cancer cells. These changes can make some cancers harder to treat, and this study aims to find a new way to target them.

What is AMG 410?

AMG 410 is a new experimental medicine that is being tested for the first time in people. It's designed to work against cancers with KRAS alterations.

Will I get AMG 410 alone or with other medicines?

Some people in the study will get AMG 410 by itself, and others will get it combined with other cancer medicines that are already approved, like Pembrolizumab or Panitumumab. The doctors will decide based on the study plan.

How long will I be on the study medicine?

You'll continue taking the medicine for as long as it's helping and you're not having difficult side effects, up to a maximum of three years.

What does a 'Phase 1' study mean?

A Phase 1 study is the first step in testing a new medicine in people. It's mainly to check if the medicine is safe, what the best dose is, and how the body handles it.

How to find out more

Amgen Call Center

medinfo@amgen.com 866-572-6436 Official trial record

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