In short
Clinical trials are investigating ANTI-GD2-800CW in children with neuroblastoma. These studies aim to check safety and help find the best phase 2 dose for imaging during surgery, as well as whether tumors can be seen clearly against normal tissue.
Key points
- Clinical trials of ANTI-GD2-800CW are studying children with neuroblastoma. The study is a first-in-human phase Ib/II, also described as phase 1/2, imaging trial. Researchers want to see if the agent is safe and if it helps surgeons detect tumors clearly. They are also working to choose the recommended phase 2 dose. The main measurement is tumor to background ratio, which shows how well the tumor stands out from normal tissue.
Trial overview
The available trial is a first-in-human imaging study of ANTI-GD2-800CW in patients with neuroblastoma. It is listed as a phase Ib/II study and is authorised.
This study is interventional, which means researchers give the study agent and then measure the results. The trial plans to enroll 22 participants.
Who is being studied
The trial is focused on pediatric patients with neuroblastoma. Neuroblastoma is the condition listed in the trial data, and it is the only target disease named for this study.
The trial description says it is meant for children with neuroblastoma, so the study population is pediatric rather than adult.
Study goals and endpoints
The main goal is to establish the recommended phase 2 dose (RP2D) based on safety and efficacy. RP2D means the dose chosen for later studies after early results show it is suitable.
Another key goal is to study safety by looking for treatment-related new adverse events. Adverse events are unwanted medical problems that happen during a study.
The primary outcome also includes whether the tumor has a tumor to background ratio (TBR) of at least 2.0 ex vivo and whether it is good enough to detect during surgery. TBR compares the fluorescence signal from the tumor with the signal from normal tissue, and ex vivo means the test is done outside the body on tissue that has been removed.
The background signal is measured in healthy kidney, liver, and surrounding background tissue. This helps researchers see whether the tumor stands out clearly from normal tissue during imaging.
Trial phase and design
The study is described as Phase 1/2 and also as Phase Ib/II. This means it is an early-stage trial that combines safety testing with an early look at whether the imaging approach works well.
The intervention listed is ANTI-GD2-800CW given as an IV infusion, which means it is administered through a vein. The study is not described as a drug treatment trial for cancer control, but as an imaging study to help detect tumors.
What participants should know
Based on the trial data, participation is limited to children with neuroblastoma in an early imaging study. The study is looking at both safety and how well the tumor can be seen, especially around the time of surgery.
The main results will help researchers decide whether ANTI-GD2-800CW should move forward in later studies and at what dose it should be studied next.