All studies
Active not recruitingPHASE1INTERVENTIONAL

A Study of Amivantamab Subcutaneous (SC) Administration for the Treatment of Advanced Solid Malignancies

This research is investigating a different way to administer a cancer drug called amivantamab. Currently, this drug is often given through a drip into a vein. This study is exploring if it can be given as an injection just under the skin (subcutaneous). The main goal is to check how safe this new injection method is, how the body handles the drug when given this way, and to determine the best dose and way to give it. This could potentially make the treatment easier and more convenient for people with advanced solid cancers. The study is in its early stages (Phase 1).

At a glance

Status
Active not recruiting
Phase
PHASE1
Sponsor
Janssen Research & Development, LLC
Enrolment target
158
Start
10 Nov 2020
Estimated completion
01 Apr 2027

What is this study about?

This study is about a cancer treatment called amivantamab. Currently, this medication is typically given through a drip directly into a vein. The researchers want to see if it's possible and effective to give this medicine as a simple injection under the skin, like many other common injections. This might make the treatment more convenient for patients and potentially reduce the time spent in clinics for infusions.

The main aim of this early-stage research (Phase 1) is to understand several key things. Firstly, they want to ensure that giving amivantamab as a subcutaneous injection is safe. Secondly, they want to see how the body absorbs and processes the drug when given this new way – this is called pharmacokinetics. Finally, based on these findings, they hope to figure out the best dose, how often it should be given, and the specific way to prepare the injection for future use.

By exploring this new method of delivery, the researchers hope to improve the treatment experience for people battling advanced solid cancers. This is an important step in making cancer treatments potentially more accessible and less disruptive to daily life, while still ensuring the medication can work effectively. It's about finding better ways to deliver existing treatments.

Key takeaways

  • This study is testing an existing cancer drug (amivantamab) given as an injection under the skin.
  • It aims to find a safe dose for this new injection method for advanced solid cancers.
  • The study is for people whose cancer has spread or can't be removed by surgery, and who have tried or cannot have other treatments.
  • This is an early-stage (Phase 1) study, focusing on safety and how the drug is processed by the body.
  • Participation involves regular clinic visits for assessments and receiving the study drug.
  • You can withdraw from the study at any time if you choose.

Who may be eligible?

To be considered for this study, you must have a solid cancer (like certain lung, head and neck, colon, or breast cancers) that has spread or can't be removed with surgery. Your doctors must also believe that this type of treatment, which targets specific cancer growth pathways, could be helpful for you. You would typically have tried standard treatments already, or those options might not be suitable for you, or you may have chosen not to have them.

You would need to be generally well enough to take part, meaning you can do light daily activities, and if you are a woman who could become pregnant, you would need to confirm you are not pregnant and use effective contraception during and for a period after the study. Men with female partners who could become pregnant would also need to use contraception.

There are also some reasons why you might not be able to join, such as having other health conditions that are not well-controlled, like high blood pressure or diabetes, or if you have an active infection.

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.

  1. Do I have a solid cancer that has spread or cannot be removed by surgery?
  2. Has my doctor said this type of targeted treatment might be right for me?
  3. Have I already tried standard treatments, or are they not suitable/desired?
  4. Am I generally well enough to be active each day?
  5. If I am a woman who could get pregnant, can I confirm I am not pregnant and use effective contraception?
  6. Do I have any other serious, uncontrolled medical conditions (like poorly controlled diabetes or high blood pressure)?
Answer every question to see your result.

What does participation involve?

If you take part in this study, you will receive the study medication, amivantamab, as an injection under your skin. The specific dose and how often you receive it will depend on the study's plan for finding the best approach. You will have regular visits to the clinic for assessments, which will include checks on your overall health, blood tests (to monitor how the drug is working in your body), and safety evaluations to look for any side effects. The exact number of visits and the total duration of your participation would be explained in full by the study team, but typically, early phase studies involve close monitoring over several months, followed by longer-term follow-up.

Potential risks and benefits

Taking part in any clinical study has potential benefits and risks. A potential benefit of this study is receiving a new way of delivering an existing cancer treatment that might be more convenient. However, there's no guarantee the treatment will work for you, or that it will be better than other options. Potential risks include side effects from the medication or the injection itself, which would be explained in detail by the study team. You have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (12)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • Cedars Sinai Medical Center
    Verified postcode
    West Hollywood, United States
  • Community Health Network
    Verified postcode
    Indianapolis, United States
  • Langone Health at NYC University, NYU School of Medicine
    Verified postcode
    New York, United States
  • Providence Portland Medical Center
    Verified postcode
    Portland, United States
  • Sarah Cannon Research Institute
    Verified postcode
    Nashville, United States
  • University Health Network
    Verified postcode
    Toronto, Canada
  • Chungbuk National University Hospital
    Verified postcode
    Cheongju-si, South Korea
  • Seoul National University Bundang Hospital
    Verified postcode
    Seongnam-si, South Korea
  • Severance Hospital Yonsei University Health System
    Verified postcode
    Seoul, South Korea
  • Samsung Medical Center
    Verified postcode
    Seoul, South Korea
  • The Christie Nhs Foundation Trust
    Verified postcode
    Manchester, United Kingdom
  • Royal Marsden Hospital
    Verified postcode
    Sutton, United Kingdom

Common questions

What is amivantamab?

Amivantamab is a medication that targets specific proteins on cancer cells to help stop their growth. This study is looking at a new way to give it.

What does 'subcutaneous administration' mean?

It means the medicine is given as an injection just under the skin, similar to an insulin shot, rather than through a drip into a vein.

What kind of cancers is this study for?

This study is for people with advanced solid cancers, such as certain types of lung, head and neck, colon, breast, and other cancers, that have spread or cannot be removed by surgery.

How long would I be in the study?

The exact duration would be explained by the study team, but typically, early-phase studies like this involve close monitoring over several months, with ongoing follow-up.

What phase is this study in?

This is a Phase 1 study, which means it's an early-stage study primarily focused on checking the safety of the new delivery method and finding the right dose.

How to find out more

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

Discussion

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