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

A Phase 1/2a Open Label, Multicenter Study to Assess the Safety, Tolerability, Pharmacokinetics, and Efficacy of AFM24 in Combination with Atezolizumab in Patients with Selected Advanced/Metastatic EGFR-expressing Cancers

This research is a trial for people with advanced cancers that have a specific feature called 'EGFR-expressing'. We're testing a new treatment combination called AFM24 and Atezolizumab. The first part of the study (Phase 1) is about making sure the new treatments are safe and finding the right dose. We'll be carefully watching for any side effects. The second part (Phase 2a) will look at how well the treatment helps shrink the cancer. We'll also check how the body handles the medicine. The study aims to see if this new combination could offer a helpful option for people with these cancers. Other medicines like Ramucirumab and Docetaxel might also be involved in comparisons.

At a glance

Status

Ongoing, recruiting

Phase

Phase I and Phase II (Integrated)- Other

Sponsor

Affimed GmbH, Affimed GmbH

Enrolment target

127

Start

17 Apr 2024

Advanced/Metastatic EGFR-expressing Cancers

What is this study about?

This study is a clinical trial, which means it's a carefully planned research project to test new treatments. It's designed for people who have advanced or metastatic cancer. 'Advanced' means the cancer has grown or spread, and 'metastatic' means it has spread from where it started to other parts of the body. The specific type of cancer this study is looking at has a particular marker on its cells called 'EGFR'. This marker can sometimes help us understand how a cancer might respond to certain treatments.

The main goal of this research is to see if a new combination of medicines, called AFM24 and Atezolizumab, can be a safe and effective treatment for these EGFR-expressing cancers. Think of it like testing a new recipe; we first need to make sure the ingredients work well together and in the right amounts, and then we see if the finished dish is tasty and helpful.

The study is split into two main parts. In the first part (Phase 1), the doctors will be very carefully checking for any side effects and trying to find the best dose of the new medicines. Once they've got that right, the second part (Phase 2a) will focus on whether the treatment actually helps shrink the cancer or stops it from growing. This is important to see if the new treatment offers a real benefit to patients.

Key takeaways

This study is testing a new combination of drugs (AFM24 and Atezolizumab) for advanced cancers with a specific marker (EGFR).
The first part of the trial focuses on finding a safe dose and understanding side effects.
The second part aims to see if the treatment helps shrink or control the cancer.
Participants will receive regular medical checks and treatments, including blood tests and scans.
This is a research study, and while it offers potential benefits, there are also risks of side effects.
You can stop participating in the study at any time without affecting your medical care.

Who may be eligible?

To join this study, you need to be at least 18 years old, and there's no upper age limit. Both men and women can take part.

More specific details about your cancer will also be considered. For example, your cancer must be 'EGFR-expressing,' which means your doctors will need to have done tests to confirm this. It also needs to be advanced or metastatic, meaning it has spread or is no longer confined to its original location.

There will also be other medical checks, like certain blood tests and a review of your overall health, to make sure it's safe for you to take part in this specific study. This is to ensure the treatment is not only appropriate for your cancer but also that your body is strong enough to handle it.

Quick self-check

Are you 18 years old or older?
Has your doctor told you that your cancer is 'EGFR-expressing'?
Has your doctor confirmed your cancer is advanced or has spread (metastatic)?
Are you able to attend regular hospital appointments for treatment and check-ups?
Are you open to trying a new and experimental treatment?
Are you interested in learning more about clinical trials?

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'll be part of a research team. It involves regular visits to the clinic for check-ups and to receive the study medications (AFM24 and Atezolizumab, and potentially others like Ramucirumab or Docetaxel). During these visits, doctors and nurses will do assessments, which might include blood tests, physical examinations, and scans (like CT or MRI scans) to see how you're responding to the treatment and to monitor your general health. This helps them track any side effects and see if the cancer is shrinking or staying stable. The first part of the study will involve particularly close monitoring for side effects. The total length of your participation would depend on how you respond to the treatment and the study's design, but it will involve ongoing check-ups for a period of time.

Potential risks and benefits

Taking part in a clinical trial offers potential benefits, such as access to new treatments before they are widely available. While there's no guarantee the treatment will work for everyone, you might find your cancer responds well. However, all medical treatments carry risks. You might experience side effects from the study drugs, some of which could be serious. The research team will carefully monitor you for any such effects and explain them in detail before you decide to join. It's really important to remember that you are free to leave the study at any time, for any reason, without affecting your regular medical care.

Locations (2)

—
Poland
—
Spain

Common questions

What does 'EGFR-expressing cancer' mean?

It means the cancer cells have a specific protein called EGFR on their surface, which can sometimes be targeted by treatments.

What are adverse events (AEs) and why are they monitored?

Adverse events are any unwanted or unexpected effects that happen during treatment. Doctors monitor them very closely to ensure the treatment is safe.

What does 'Phase 1' of the study mean?

Phase 1 is the first stage where doctors mainly check for safety and try to find the right dose of the new treatment.

What does 'Phase 2a' of the study mean?

Phase 2a comes after Phase 1 and focuses on how well the treatment works to shrink or control the cancer, while still watching for safety.

Will I definitely get the new treatment combination?

Yes, in this study, everyone who takes part will receive the new treatment combination of AFM24 and Atezolizumab, with other medicines potentially given alongside it.