RecruitingPHASE1INTERVENTIONAL

Anti-GD2 ADC M3554 in Advanced Solid Tumors

This research is testing a new medicine, M3554, for advanced cancers that haven't responded to previous treatments. Specifically, it's for adults with advanced soft tissue sarcoma or a specific type of brain tumour called glioblastoma. The main goals are to figure out the best and safest dose of M3554, and to see if it can help shrink or control the cancer. While this is an early-stage study, meaning we're still learning a lot about this new treatment, it's an important step in developing new ways to fight these serious cancers. Each person involved in the study will take part for around four months.

At a glance

Status

Recruiting

Phase

PHASE1

Sponsor

EMD Serono Research & Development Institute, Inc.

Enrolment target

Start

08 Nov 2024

Estimated completion

16 Apr 2027

Advanced Solid Tumor

What is this study about?

This study is all about a new investigational medicine called M3554. An investigational medicine is one that's still being tested and isn't yet available as a standard treatment. We're looking at it for adults who have two specific types of advanced cancer: soft tissue sarcoma (a cancer that starts in soft tissues like muscle or fat) or a certain kind of brain tumour called glioblastoma. These are cancers that have grown or spread and haven't responded to earlier treatments.

The main purpose of this early study (called Phase 1) is to work out the best and safest dose of M3554. We also want to understand any side effects it might have and get an early idea of whether it can help control the cancer. This kind of research is really important for finding new ways to treat cancer, especially when current treatments are no longer working as well as hoped.

Taking part in a study like this means you would be trying a new medicine. It helps scientists learn more about how the medicine works, how it affects people, and whether it could become a useful treatment in the future. Remember, participating is always a choice, and your doctors will be there to guide you through the process.

Key takeaways

It's an early-stage study for a new medicine called M3554.
It's for specific advanced cancers: soft tissue sarcoma or glioblastoma.
The main goals are to find a safe dose and see how the medicine works.
Participation lasts about four months, with regular checks.
You have the right to leave the study at any time.
Always discuss with your doctor if it's right for you.

Who may be eligible?

This study is looking for adults who have a specific type of advanced soft tissue sarcoma which has already been treated with at least one type of chemotherapy, and that treatment is no longer working. If you've had surgery for your soft tissue sarcoma, you might still be able to join if some cancer remains.

We are also looking for adults with a specific type of brain tumour called glioblastoma (known as IDH-wildtype) where the cancer has progressed after only one previous treatment. This treatment usually includes radiotherapy, sometimes with another medicine called temozolomide. Your brain tumour must have become worse at least three months after your radiotherapy finished.

To join, you also need to be generally well enough to take part, meaning you can do most of your normal daily activities without too much trouble. We'll also check that your blood, liver, and kidney functions are working properly. There are other specific rules about who can and cannot join, and your doctor will discuss all of them with you.

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 an adult aged 18 or over?
Do you have advanced soft tissue sarcoma that has progressed after at least one prior chemotherapy treatment?
OR do you have a specific type of glioblastoma (IDH-wildtype) that has progressed after only one prior treatment, and at least 3 months after radiotherapy?
Are you generally well and able to perform most daily activities?
Have your doctors confirmed you meet the required blood, liver, and kidney function levels?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, the total time you'd be involved is around four months. During this period, you would receive the study medicine, M3554. You'll have regular appointments with the study team, which will include examinations, blood tests, and scans to check your health and how the medicine is affecting your cancer. The team will carefully monitor you for any side effects and to see how the treatment is working.

After you finish receiving the study medicine, you'll still have follow-up visits or calls to check on your health. The exact schedule of visits and tests will be explained in detail by the study team. They will make sure you understand everything involved before you make any decisions.

Potential risks and benefits

Taking part in any medical study has potential benefits and potential risks. A potential benefit of joining this study is that you might receive a new treatment (M3554) that is not generally available, which could potentially help control your cancer. However, as M3554 is a new medicine, there might be side effects that are not yet fully known or understood. The study team will closely monitor you for any side effects and will explain all known risks. It's important to remember that you are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (11)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Dana-Farber Cancer Institute
Verified postcode
Boston, United States· Recruiting
Memorial Sloan-Kettering Cancer Center (MSKCC) - New York - Memorial Sloan Kettering Cancer Center (CC)- Westc
Verified postcode
New York, United States· Withdrawn
The University of Texas MD Anderson Cancer Center
Verified postcode
Houston, United States· Recruiting
UZ Leuven
Verified postcode
Leuven, Belgium· Recruiting
Institut Bergonié - Service d'Oncologie Médicale
Verified postcode
Bordeaux, France· Recruiting
Centre Oscar Lambret - cancerologie generale
Verified postcode
Lille, France· Recruiting
Centre Leon Berard - Service d'Oncologie Medicale
Verified postcode
Lyon, France· Recruiting
Centre Antoine Lacassagne - Service d'Hématologie Oncologie
Verified postcode
Nice, France· Recruiting
National Cancer Center Hospital
Verified postcode
Chūōku, Japan· Recruiting
Universitaetsspital Zuerich - Klinik fuer Neurologie
Verified postcode
Zurich, Switzerland· Recruiting
Royal Marsden Hospital-Sutton - Dept of Oncology (Surrey)
Verified postcode
Sutton, United Kingdom· Recruiting

Common questions

What is M3554?

M3554 is a new medicine being tested in this study; it's not yet available as a standard treatment.

What types of cancer is this study for?

This study is for people with certain forms of advanced soft tissue sarcoma or a specific type of brain tumour called glioblastoma.

How long will I be in the study?

Each participant is expected to be involved in the study for approximately four months.

What are the goals of this study?

The main goals are to find the safest dose of the new medicine, check its safety, and see if it can help fight the cancer.

Can I leave the study at any time?

Yes, you can choose to stop participating in the study at any point, and it won't affect your future medical care.

How to find out more

US Medical Information

eMediUSA@emdserono.com 888-275-7376 Official trial record

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