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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

Open

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

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DiagnosisSolid TumorStudy StatusOpen
PhaseI
Age12 Years and olderRandomisationNO
Line of treatmentDisease relapse or progression
Routes of Treatment AdministrationDrug: 23ME-00610 (IV infusion)
Last Posted Update2023-06-29
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

NAIT Program 

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