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GD2-SADA:177Lu-DOTA Complex in Patients With Solid Tumors Known to Express GD2

Last Update Posted : 2024-04-04

The aim of the trial

  • The aim of this trial is to test a new drug called GD2-SADA:177Lu-DOTA complex in GD2 positive cancers. GD2 is a marker found in some cancers and can be targeted by drugs. The trial will focus on assessing the side effects and finding the best dose of the drug. This trial is open to several cancer types. This includes osteosarcoma.
Country
United States,
Locations
Scottsdale, Duarte, Chicago, Grand Rapids, New York, Cleveland, Pittsburgh, Madison,
Trial Type
Interventional
Trial Phase
Phase 1,
Trial Status
Recruiting
Minimum age
16 Years
Maximum age
-
Key Contact
-Joris Wilms, +4570261414, clinicaltrials@ymabs.com,
Clinical Trial ID
NCT05130255

Key Information

  • Although this trial is not assessing the effectiveness of the drug. The drug may still be effective in treating cancer in some people.

How the treatment works

  • GD2-SADA:177Lu-DOTA complex is a radioimmunotherapy drug. This means it consists of a small amount of radiation and a drug called a monoclonal antibody (MAB). MABs can recognise specific markers on cancer cells and bind to them. The radioactive substance bound to the monoclonal antibody then gives off radiation to kill cancer cells.
  • Visit our drugs and interventions page to find out more about this treatment, including how it works and what it’s used for.

Who is the trial for?

  • The below points are a summary of who can enter the trial.
  • People with sarcoma that has returned or not responded to first-line treatment and has spread or can not be removed with surgery.
  • People with cancer that can be measured according to RECIST 1.1. Your doctor will know this.
  • People with an ECOG performance score of 0-1. Your doctor will know this.
  • People with adequate kidney and bone marrow function. You will have tests to check this.

Who is the trial not for?

  • The below points are a summary of who can’t enter the trial.
  • People who have had chemotherapy, radiotherapy, immunotherapy, or major surgery in the 3 weeks before the start of the trial.
  • People receiving any other treatment as part of the trial in the 3 weeks before the start of the trial.
  • People with ongoing side effects from previous radiation therapy.
  • People with a diagnosis of autoimmune diseases or immunodeficiencies.
  • People with HIV, or active hepatitis B or C.
  • People who have had prior treatment with anti-GD2 antibody.

Disclaimer

  • ONTEX is intended to supplement, not replace, your healthcare team. Patients should always discuss a clinical trial with their healthcare team. If a patient is eligible for a trial the trial team will be able to provide more in-depth information about the trial so the patient can make an informed decision before taking part. Trial information has been sourced from www.clinicaltrials.gov. The content is then reviewed weekly by the Osteosarcoma Now team. All the trials also have a patient-friendly summary and key information section written by the team at Osteosarcoma Now. We have also included a description of the medications being used in the trial and summarised the inclusion and exclusion criteria in the ‘who is this trial (not) for’ sections. To the best of our knowledge the clinical trial database is up-to-date and accurate.However, we cannot assume any liability for the accuracy or completeness of the information.