This is an open-label, multicenter study to assess safety, tolerability, pharmacokinetics (PK), immunogenicity, pharmacodynamics (PD), and preliminary efficacy of RO7428731 administered as a monotherapy in participants with newly diagnosed or recurrent epidermal growth factor receptor variant III (EGFRvIII)-positive glioblastoma (GBM).
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
36
Participants will receive RO7428731 as described.
UCLA Neuro-Oncology Program
Los Angeles, California, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Peter MacCallum Cancer Centre
Melbourne, Victoria, Australia
Princess Margaret Cancer Center
Toronto, Ontario, Canada
Percentage of Participants with Adverse Events (AEs)
Time frame: Up to the safety follow-up visit 60 days after the last treatment (up to approximately 15 months)
Percentage of Participants with Dose Limiting Toxicities (DLTs)
Time frame: Cycle 1 (each cycle is 21 days)
Serum Concentration of RO7428731
Time frame: Up to the safety follow-up visit 60 days after the last treatment (up to approximately 15 months)
Percentage of Participants With RO7428731 Anti-drug Antibodies (ADAs)
Time frame: From baseline up to the safety follow-up visit 60 days after the last treatment (up to approximately 15 months)
Objective Response Rate (ORR)
Time frame: From start of study treatment up to approximately 3 years
Disease Control Rate (DCR)
Time frame: From start of study treatment up to approximately 3 years
Duration of Response (DOR)
Time frame: From the time of first occurrence of a documented response until the time of documented disease progression or death (death within 30 days from last study treatment) from any cause, whichever occurs first (up to approximately 3 years)
Progression-free Survival (PFS)
Time frame: From start of study treatment to the first occurrence of documented disease progression or death from any cause, whichever occurs first (up to approximately 3 years)
Overall Survival (OS)
Time frame: From start of study treatment to the time of death from any cause (up to approximately 3 years)
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Rigshospitalet, Onkologisk Klinik
København Ø, Denmark
Clinica Universitaria de Navarra
Pamplona, Navarre, Spain
Vall d?Hebron Institute of Oncology (VHIO), Barcelona
Barcelona, Spain
Clinica Universidad de Navarra Madrid
Madrid, Spain