A Study Evaluating the Safety, Pharmacokinetic and Anti-tumour Activity of RO7428731 in Participants With Glioblastoma

Official Title

An Open-label, Multicentre, 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

Summary:

This is an open-label, multicentre 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).

Trial Description

Primary Outcome:

  • Percentage of Participants with Adverse Events (AEs)
  • Percentage of Participants with Dose Limiting Toxicities (DLTs)
Secondary Outcome:
  • Maximum Plasma Concentration (Cmax) of RO7428731
  • Time to Maximum Plasma Concentration (Tmax) of RO7428731
  • Minimum Observed Serum Concentration (Cmin) of RO7428731
  • Clearance (CL) of RO7428731
  • Half-life (t1/2) of RO7428731
  • Volume of Distribution at Steady State (Vss) of RO7428731
  • Area Under the Plasma Concentration-Time Curve (AUC) of RO7428731
  • Percentage of Participants With RO7428731 Anti-drug Antibodies (ADAs)
  • Objective Response Rate (ORR)
  • Disease Control Rate (DCR)
  • Duration of Response (DOR)
  • Progression-free Survival (PFS)
  • Overall Survival (OS)

View this trial on ClinicalTrials.gov

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Resources

Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society