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Information is also accessible through the patient and families tab. Family friendly summaries are created and reviewed by our advocacy partners. The information is updated to the best of our knowledge but might not reflect the latest information. Note that most studies are only available at a limited number of sites, please click on ‘further information’ for details. Studies, particularly early phase trials, may also temporarily close to enrolment or not have slots available for all treatment groups. In all cases, study teams at individual C17 centres will have the most up-to-date information.

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Title
Status

 

23ME-00610-CLIN-001 - A Phase 1, Multicenter, Open-Label, Dose-Escalation and Expansion Study of Intravenously Administered 23ME-00610 in Patients With Advanced Solid Malignancies

Closed to enrollment

23ME-00610-CLIN-001 - A Phase 1, Multicenter, Open-Label, Dose-Escalation and Expansion Study of Intravenously Administered 23ME-00610 in Patients With Advanced Solid Malignancies

Go to Health Care Provider version

DiagnosisSolid TumorStudy StatusClosed to enrollment
PhaseI
Age12 Years and olderRandomisationNO
Line of treatmentDisease relapse or progression
Routes of Treatment AdministrationDrug: 23ME-00610 (IV infusion)
Last Posted Update2024-03-18
ClinicalTrials.gov #NCT05199272
International Sponsor
23andMe, Inc.
Principal Investigators for Canadian Sites
The Hospital for Sick Children - Dr. Daniel Morgenstern


Centres
Medical contact

Dr. Daniel Morgenstern

daniel.morgenstern@sickkids.ca

Social worker/patient navigator contact

Karen Fung 

karen.fung@sickkids.ca

Clinical research contact

New Agent and Innovative Therapies (NAIT) 

nait.info@sickkids.ca

 

 

 

Study Description

This is a Phase 1 clinical trial designed to study a drug called 23ME-00610 in children and adults with advanced solid tumors that have not responded to or gotten worse after stardard therapy, or where no further standard therapy exists. In Part A of this study, researchers are looking to find the best possible dose of 23ME-00610 (called the recommended phase 2 dose). Part B of this study will evaluate how the patients body responds to the drug 23ME-00610 and continue monitoring safety. 

Inclusion Criteria
  • To enroll in Part B of the study, the patient must be  ≥ 12 years of age
  • Patient must weigh at least 40kg
  • Patient must have a solid tumor:
    • that has progressed after all available standard therapy
    • or for which standard therapy has been ineffective
    • or for which no standard therapy exists
  • Patient is up and about for at least half of their waking hours 
  • Patient must have a solid tumor that has not previously been exposed to radiation

Additional inclusion or exclusion criteria may apply and will be discussed with you by the study team