RecruitingPHASE1, PHASE2INTERVENTIONAL

A Study of Amivantamab Monotherapy and in Addition to Standard-of-Care Chemotherapy in Participants With Advanced or Metastatic Colorectal Cancer

This study is looking into a new treatment called amivantamab for people with advanced bowel cancer that has spread. Researchers want to see how effective this new drug is, both by itself and when given alongside standard chemotherapy treatments. They will also carefully check what side effects people experience to understand its safety. The main goal is to find out if amivantamab can help shrink tumours or stop them from growing, potentially offering new options for patients. The study involves different groups, some receiving just amivantamab, and others getting it with existing chemotherapy drugs. It's an important step in exploring new ways to fight advanced bowel cancer.

At a glance

Status

Recruiting

Phase

PHASE1, PHASE2

Sponsor

Janssen Research & Development, LLC

Enrolment target

225

Start

29 Jul 2022

Estimated completion

31 Oct 2030

Advanced or Metastatic Colorectal Cancer

What is this study about?

This research study is about finding new and better ways to treat advanced bowel cancer. When bowel cancer has spread to other parts of the body, it's called advanced or metastatic colorectal cancer. At the moment, there are standard treatments, but doctors are always looking for new options to help patients.

The main focus of this study is a new drug called amivantamab. This drug works in a specific way by targeting certain signals on cancer cells that help them grow. Researchers want to see if amivantamab can stop these cancer cells from growing or even shrink them. They are testing it in a couple of ways: first, by giving it on its own to some patients, and second, by combining it with the chemotherapy drugs that patients usually receive.

By doing this, the study aims to understand two key things: how well amivantamab works against the cancer, and how safe it is for patients. They will carefully monitor patients for any side effects and see if the drug helps improve their condition. This information will help doctors decide if amivantamab could become a useful new treatment option for people with advanced bowel cancer in the future.

Key takeaways

This study evaluates amivantamab, a new drug for advanced bowel cancer.
It aims to see if the drug works when used alone or with standard chemotherapy.
Researchers will closely monitor its effects and safety.
The study has specific requirements for who can take part.
It's an early-stage study (Phase 1/2) looking for new treatment possibilities.

Who may be eligible?

To join this study, you must have been diagnosed with advanced bowel cancer that can't be removed by surgery or has spread. Your specific type of cancer needs to have certain genetic features (your KRAS, NRAS, and BRAF genes must be normal, and you shouldn't have too much of the HER2 gene).

Depending on which part of the study you might join, there are other requirements. For some parts, you must have already had 2 or 3 types of treatment for your advanced cancer, and you must have already received or couldn't tolerate standard chemotherapy drugs and a specific type of anti-VEGF treatment. Also, whether you've had anti-EGFR treatment before will matter for some groups.

For other parts of the study, you might only have had one previous line of treatment for your advanced cancer. You also need to be suitable to receive specific chemotherapy combinations, such as mFOLFOX6 or FOLFIRI, and for some groups, you must not have received certain chemotherapy drugs in the past.

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.

Do you have advanced bowel cancer that has spread?
Has your cancer been tested for specific genetic features (KRAS, NRAS, BRAF, HER2)?
Have you had at least 2 or 3 previous treatments for your advanced cancer (for some parts of the study)?
Have you had no more than 1 previous treatment for your advanced cancer (for other parts of the study)?
Are you able to receive certain chemotherapy drugs like mFOLFOX6 or FOLFIRI?
Are you 18 years old or older?

Answer every question to see your result.

What does participation involve?

If you join this study, there will be a screening period of up to 28 days to make sure it's right for you. During this time, you'll have various checks like physical exams, blood tests, and scans. Once you start treatment, you will receive the study drug (amivantamab) either on its own or with standard chemotherapy. The treatment usually involves cycles lasting 28 days each.

You will continue these cycles until your doctor decides that the treatment is no longer beneficial or if you experience significant side effects. Throughout the study, you will have regular appointments, including physical examinations, blood tests, and checks of your overall health and well-being. Doctors will closely monitor a range of things like your vital signs, any side effects you experience, and any other medications you are taking. After you stop the study treatment, there will be a follow-up period of up to 30 days to check your health.

Potential risks and benefits

Taking part in any clinical trial has potential benefits and risks. A potential benefit of this study is that you might be among the first to receive a new treatment that could help manage your bowel cancer more effectively than current options. However, it's important to remember that new treatments don't always work for everyone, and there's no guarantee of improvement. There could also be side effects from the study drug, some of which might be serious, and these will be carefully explained to you by the study team. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (53)

O Neal Comprehensive Cancer Center at UAB
Verified postcode
Birmingham, United States· Completed
University of Southern California
Verified postcode
Los Angeles, United States· Completed
University of California, Los Angeles UCLA
Verified postcode
Los Angeles, United States· Recruiting
Georgetown University Hospital
Verified postcode
Washington D.C., United States· Completed
H Lee Moffitt Cancer Center
Verified postcode
Tampa, United States· Completed
University of Maryland School of Medicine
Verified postcode
Baltimore, United States· Completed
University of Michigan Health System
Verified postcode
Ann Arbor, United States· Recruiting
Start Midwest
Verified postcode
Grand Rapids, United States· Completed
Hattiesburg Clinic
Verified postcode
Hattiesburg, United States· Recruiting
NYU Langone Long Island Clinical Research Associates
Verified postcode
New York, United States· Recruiting
Herbert Irving Comprehensive Cancer Center Columbia University Medical Center
Verified postcode
New York, United States· Recruiting
Stephenson Cancer Center
Verified postcode
Oklahoma City, United States· Active not recruiting

Common questions

What is advanced or metastatic colorectal cancer?

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

What is amivantamab?

It's a new type of drug being tested, designed to target specific signals on cancer cells to stop them from growing.

Will I get this new drug on its own or with other treatments?

The study has different groups; some people get amivantamab alone, and others get it combined with standard chemotherapy drugs.

What is a 'phase 1' or 'phase 2' study?

These are early stages of testing new drugs. Phase 1 focuses on safety, and Phase 2 looks at how well the drug works and continues to check safety.

How long will I be in the study if I join?

There's a screening period, then treatment in 28-day cycles, and a follow-up period after treatment stops. The total length depends on how you respond to the treatment.

How to find out more

Study Contact

participate-in-this-study1@its.jnj.com 844-434-4210 Official trial record

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