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ANTI-GD2-800CW

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.

Table of contents

Trial overview

The available trial is a first-in-human imaging study of ANTI-GD2-800CW in patients with neuroblastoma.[1] It is listed as a phase Ib/II study and is authorised.[1]

This study is interventional, which means researchers give the study agent and then measure the results.[1] The trial plans to enroll 22 participants.[1]

Who is being studied

The trial is focused on pediatric patients with neuroblastoma.[1] Neuroblastoma is the condition listed in the trial data, and it is the only target disease named for this study.[1]

The trial description says it is meant for children with neuroblastoma, so the study population is pediatric rather than adult.[1]

Study goals and endpoints

The main goal is to establish the recommended phase 2 dose (RP2D) based on safety and efficacy.[1] RP2D means the dose chosen for later studies after early results show it is suitable.[1]

Another key goal is to study safety by looking for treatment-related new adverse events.[1] Adverse events are unwanted medical problems that happen during a study.[1]

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.[1] 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.[1]

The background signal is measured in healthy kidney, liver, and surrounding background tissue.[1] This helps researchers see whether the tumor stands out clearly from normal tissue during imaging.[1]

Trial phase and design

The study is described as Phase 1/2 and also as Phase Ib/II.[1] This means it is an early-stage trial that combines safety testing with an early look at whether the imaging approach works well.[1]

The intervention listed is ANTI-GD2-800CW given as an IV infusion, which means it is administered through a vein.[1] The study is not described as a drug treatment trial for cancer control, but as an imaging study to help detect tumors.[1]

What participants should know

Based on the trial data, participation is limited to children with neuroblastoma in an early imaging study.[1] The study is looking at both safety and how well the tumor can be seen, especially around the time of surgery.[1]

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.[1]

Trial ID Phase Condition studied Status Enrollment
2023-507596-22-00 Phase 1/2 Neuroblastoma Authorised 22

FAQ

  • What is being studied in ANTI-GD2-800CW trials? The trials are studying ANTI-GD2-800CW as an imaging agent in children with neuroblastoma. The main goals are to assess safety and whether the tumor can be detected clearly during surgery.
  • Who can participate in these trials? The trial data describe pediatric patients with neuroblastoma. The study is designed for children who have this condition and are being considered for surgical imaging.
  • What phase is the ANTI-GD2-800CW study? This is a phase Ib/II study, also described as phase 1/2. That means it is an early study looking at both safety and how well the imaging works.
  • What results are the researchers measuring? Researchers are measuring treatment-related new adverse events and tumor to background ratio, or TBR. TBR compares the signal from the tumor with the signal from nearby normal tissue.
  • What condition is being studied? The only condition listed in the trial data is neuroblastoma. This is the cancer being studied in the ANTI-GD2-800CW imaging trial.

Ongoing Clinical Trials on ANTI-GD2-800CW

  • Study of Anti-GD2-800CW for Imaging in Children with Neuroblastoma

    Recruiting

    2 1 1
    Investigated diseases:
    Investigated drugs:
    The Netherlands

Glossary

  • Neuroblastoma: A type of cancer that starts in early nerve cells. In this trial, it is the disease being studied in children.
  • Imaging study: A study that looks at how well a substance helps doctors see tumors or body tissues, often during surgery.
  • First-in-human: The first time a study treatment is tested in people. It is an early step in research.
  • Phase Ib/II: An early clinical trial phase that looks at safety, dose, and whether the study method seems to work.
  • Interventional study: A trial in which researchers give a treatment or procedure and then measure what happens.
  • Recommended phase 2 dose (RP2D): The dose chosen for later studies after early testing shows it is suitable based on safety and other results.
  • Adverse events: Unwanted medical problems that happen during a study. The trial is checking for new treatment-related adverse events.
  • Tumor to background ratio (TBR): A number that compares the tumor signal with the signal from normal tissue. A higher ratio can mean the tumor is easier to see.
  • Ex vivo: A test done outside the body, such as on removed tissue.
  • Fluorescence signal: The light signal measured from tissue after imaging, used to help find the tumor.

References

  1. https://clinicaltrials.gov/study/2023-507596-22-00