Active not recruitingPHASE1INTERVENTIONAL

A Study of LY3295668 Erbumine in Participants With Relapsed/Refractory Neuroblastoma

This research study is for children and young adults, aged 2 to 21, who have neuroblastoma that has either returned after treatment or hasn't responded to previous therapies. The main goal is to test a new medicine named LY3295668 erbumine. We want to learn if this medicine is safe for patients and how their bodies react to it. Participants will take the medicine, and doctors will carefully monitor them for any side effects. This study aims to gather important information that could help develop new ways to treat neuroblastoma in the future. It's an early-stage study, meaning it's one of the first times this medicine is being tested in people.

At a glance

Status

Active not recruiting

Phase

PHASE1

Sponsor

Eli Lilly and Company

Enrolment target

Start

11 Jun 2020

Estimated completion

01 Aug 2026

Neuroblastoma

What is this study about?

This study is focused on a type of cancer called neuroblastoma, which often affects young children. Sometimes, after initial treatments, neuroblastoma might come back (what doctors call 'relapsed') or it might not respond as well as hoped to existing treatments (known as 'refractory'). When this happens, we need to find new and effective ways to help.

That's where this study comes in. Researchers are investigating a new medicine called LY3295668 erbumine. The main purpose of this early study (called 'Phase 1') is to see if this new medicine is safe for young people with relapsed or refractory neuroblastoma. Doctors will give the medicine and watch carefully to see how patients respond and if there are any side effects. They'll also check to see what dose is safe.

The information gathered from studies like this is really important. It helps scientists understand how new medicines work and if they could potentially be helpful for patients in the future. It's a key step in developing better treatments and improving the lives of children and young adults facing neuroblastoma.

Key takeaways

This study is testing a new medicine for neuroblastoma that has come back or not responded to other treatments.
It's for children and young people aged 2 to 21.
The main goal is to see if the new medicine is safe.
Participants will take the medicine as capsules and have regular check-ups.
It's an early-stage study, meaning we are learning about this medicine for the first time in people.
You can stop participating at any time.

Who may be eligible?

To join this study, children and young people need to be between 2 and 21 years old and have neuroblastoma that has come back or hasn't responded to earlier treatments. The disease must be active in areas like their bones, bone marrow, or soft tissues. Participants also need to be able to swallow capsules, as the study medicine is taken this way.

There are also some reasons why someone might not be able to join. For example, if they've had certain types of transplants (like a stem cell or organ transplant), or if the neuroblastoma has spread to their brain or spinal cord without being treated. They also shouldn't have other serious illnesses, problems absorbing medicines, or a known allergy to any part of the study treatment. If they've taken similar medicines recently or have certain active infections like HIV or hepatitis, this would also mean they can't take part.

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.

Am I, or the person I care for, between 2 and 21 years old?
Do I have neuroblastoma that has come back or not responded to previous treatments?
Is the neuroblastoma currently active in my bone, bone marrow, or soft tissue?
Am I able to swallow capsules?
Have I had an organ or stem cell transplant?
Do I have any other serious untreated diseases or active infections like HIV or hepatitis?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will be given the study medicine, LY3295668 erbumine, which you will take as capsules. You will need to attend regular appointments at the hospital. At these visits, doctors will perform examinations and tests, which might include blood tests and scans, to check on your health and how you are responding to the medicine. They will also carefully watch for any side effects you might experience. The exact number and frequency of visits will be explained by the study team. They will also tell you the total length of time you will be involved in the study.

Potential risks and benefits

Taking part in a study like this might offer a potential benefit by giving you access to a new medicine that isn't widely available yet, which could help with your neuroblastoma. However, it's also important to know that there are potential risks. The medicine might cause side effects, and we don't know the full extent of these yet, as it's a new treatment. The care team will explain all known and potential side effects to you. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (17)

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

UCSF Medical Center at Mission Bay
Verified postcode
San Francisco, United States
Children's Hospital Colorado
Verified postcode
Aurora, United States
University of Chicago - Comer Children's Hospital
Verified postcode
Chicago, United States
Dana-Farber Cancer Institute
Verified postcode
Boston, United States
Cincinnati Childrens Hospital Medical Center
Verified postcode
Cincinnati, United States
Children's Hospital of Philadelphia
Verified postcode
Philadelphia, United States
Texas Childrens Hospital
Verified postcode
Houston, United States
Perth Children's Hospital
Verified postcode
Perth, Australia
UZ Gent
Verified postcode
Ghent, Belgium
Centre Leon Berard
Verified postcode
Lyon, France
Institut Curie
Verified postcode
Paris, France
Universitätsklinikum Köln
Verified postcode
Cologne, Germany

Common questions

What is neuroblastoma?

Neuroblastoma is a type of cancer that often affects young children, starting in nerve tissue outside of the brain.

What does 'relapsed/refractory' mean?

This means the neuroblastoma has either come back after previous treatment, or it hasn't responded well to earlier treatments.

What is the new medicine being tested?

The new medicine is called LY3295668 erbumine. It's an early-stage medicine not yet widely available.

Will I get other cancer treatments during the study?

The study will focus on LY3295668 erbumine. Your doctor will discuss all your treatment options with you.

Who is funding this research?

Clinical trials are typically funded by pharmaceutical companies, government agencies, or charitable organisations. Your doctor can provide specific funding details for this study.