LIGHTBEAM-U01 Substudy 01D: A Phase 1b/2 Substudy to Evaluate the Safety and Efficacy of Ifinatamab Deruxtecan in Pediatric Participants With Relapsed or Refractory Solid Tumors
This research study is testing a new medicine called Ifinatamab Deruxtecan for children between 1 month and 12 years old who have solid cancers that have come back or not responded to previous treatments. The study has two main goals: firstly, to check for any side effects and find a safe dose for the medicine. Secondly, it aims to see how well the medicine works at shrinking tumors or stopping their growth in specific types of cancer like neuroblastoma, rhabdomyosarcoma, Wilms tumor, and osteosarcoma. This is an early-stage study, meaning it's one of the first times this medicine is being tested in children for these conditions.
At a glance
What is this study about?
This study is looking at a new medicine called Ifinatamab Deruxtecan. It's designed for children aged from one month old up to their 12th birthday, who have specific types of solid tumors (cancers that form a lump) that haven't got better with other treatments, or have come back after treatment.
This is an early-stage clinical trial, often called a Phase 1b/2 study. This means it has two main parts. The first part focuses on safety: researchers want to find the right dose of the new medicine and understand its possible side effects. The second part will then look at whether the medicine is effective at shrinking tumors or stopping them from growing in certain cancers, such as neuroblastoma, rhabdomyosarcoma, Wilms tumor, and osteosarcoma.
The main idea is to see whether this new medicine has the potential to help children with these serious conditions, carefully balancing safety with the hope of a positive treatment effect. The study will gather detailed information on how the medicine affects the body and how patients respond.
Key takeaways
- Tests a new medicine called Ifinatamab Deruxtecan.
- For children (1 month to under 12 years) with specific solid cancers.
- Cancers must have returned or not responded to other treatments.
- Early-stage study focused on safety and effectiveness.
- Participation involves regular hospital visits for treatment and monitoring.
- You can withdraw your child from the study at any time.
Who may be eligible?
To be able to join this study, children need to be at least one month old but not yet 12 years old. They must have a diagnosis of a solid tumor cancer that has either returned after previous treatment or hasn't responded to other available treatments.
Because this is an early-stage study for a new medicine, there will be other specific medical checks and tests that a child would need to pass to make sure the study is safe and appropriate for them. The study team will review all a child's medical information carefully to see if they are a good fit.
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.
- Is my child between 1 month and 12 years old?
- Does my child have a solid tumor cancer?
- Has my child's cancer come back or not responded to other treatments?
- Is my child generally well enough to participate in a study?
- Am I able to commit to regular hospital visits for my child?
What does participation involve?
If a child is eligible and you decide to take part, they would receive the study medicine, Ifinatamab Deruxtecan. The study involves regular visits to the hospital for treatment, check-ups, and tests. These tests might include blood samples, scans (like X-rays or MRI), and other assessments to monitor their health, see how the medicine is working, and check for any side effects.
The exact number and timing of visits and tests would be explained in detail by the study team. They will also outline how long each treatment cycle lasts and the total expected duration of your child's involvement in the study. You'll be given a schedule to help you understand what to expect.
Potential risks and benefits
Locations (7)
- —UnverifiedFrance
- —UnverifiedSpain
- —UnverifiedSweden
- —UnverifiedGermany
- —UnverifiedItaly
- —UnverifiedBelgium
- —UnverifiedDenmark
Common questions
What kind of cancer is this study for?
This study is for children with certain solid tumor cancers, such as neuroblastoma, rhabdomyosarcoma, Wilms tumor, and osteosarcoma, that haven't responded to previous treatments or have returned.
What is Ifinatamab Deruxtecan?
It's a new experimental medicine being tested to see if it can treat these types of cancer.
Who can take part in this study?
Children aged from 1 month up to their 12th birthday who meet specific medical criteria can be considered for the study.
Will my child get the actual medicine or a dummy treatment?
In this study, all participants who are eligible will receive the study medicine, Ifinatamab Deruxtecan. There is no placebo (dummy treatment) in this trial.
What are the main goals of the study?
The study aims to find a safe dose for the new medicine and see if it can shrink tumors or stop them from growing.
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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