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Diagnosis | Solid Tumor | Study Status | Closed to enrollment |
Phase | I |
Age | 12 Years and older | Randomisation | NO |
Line of treatment | Disease relapse or progression |
Routes of Treatment Administration | Drug: 23ME-00610 (IV infusion) |
Last Posted Update | 2024-03-18 |
ClinicalTrials.gov # | NCT05199272 |
International Sponsor
23andMe, Inc.Principal Investigators for Canadian Sites
The Hospital for Sick Children - Dr. Daniel Morgenstern
Centres
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