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Title
Status

 

BP42573 - An Open-label, Multicenter, Phase I Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Clinical Activity of RO7428731 in Participants With Glioblastoma Expressing Mutant Epidermal Growth Factor Receptor Variant III

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BP42573 - An Open-label, Multicenter, Phase I Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Clinical Activity of RO7428731 in Participants With Glioblastoma Expressing Mutant Epidermal Growth Factor Receptor Variant III

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DiagnosisGlioblastomaStudy StatusOpen
PhaseI
Age18 Years and olderRandomisationNO
Line of treatmentFirst line treatment, Disease relapse or progression
Routes of Treatment AdministrationDrug: RO7428731, intravenously (IV)
Last Posted Update2024-06-21
ClinicalTrials.gov #NCT05187624
International Sponsor
Hoffmann-La Roche
Principal Investigators for Canadian Sites
Princess Margaret Cancer Centre
Centres
Medical contact

    CNS - Dr. Julie Bennett

     julie.bennett@sickkids.ca

     Sarcoma - Dr. Abha Gupta

     abha.gupta@uhn.ca

     Leukemia & Lymphoma - Dr. Dawn Maze

     dawn.maze@uhn.ca

Social worker/patient navigator contact

Please contact medical team for further information.

Clinical research contact

     CNS Trials - On Yee Jones

     onyee.jones@uhn.ca

     Sarcoma Trials - Hagit Peretz Soroka

     hagit.peretz@uhn.ca

     Leukemia & Lymphoma Trials - Deborah Sanfelice 

     deborah.Sanfelice@uhn.ca

 

 

Study Description

 

A clinical trial to look at how safe and tolerable the drug RO7428731 is at different doses, how the body processes it, and if there are any early signs of treatment efficacy of RO7428731 in patients with glioblastoma that has the marker EGFRvIII

Via: Clinical Trial – Glioblastoma – Safety, Tolerability, Pharm... (roche.com)

Inclusion Criteria
  • Diagnosis of glioblastoma with a tumour expression called EGFRvIII
  • Must have completed standard of care therapy prior to joining this study
  • Must be up and about at least 70% of their waking hours
  • Adequate organ functions prior to start of study treatment
  • Willingness to abide by contraceptive measures for the duration of the study.

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