A Study Evaluating the Safety, Pharmacokinetic and Anti-tumor Activity of RO7428731 in Participants With Glioblastoma
NCT05187624 2021-001197-37 BP42573
The source of the below information is the publicly available website ClinicalTrials.gov. It has been summarised and edited into simpler language.
The below information is taken directly from the publicly available website ClinicalTrials.gov within a week of any updates, and has not been edited.
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).
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
Inclusion criteria for all participants:
- Life expectancy of greater than or equal to 12 weeks, in the opinion of the Investigator
- Diagnosis of GBM based on the Consortium to Inform Molecular and Practical Approaches to Central Nervous System Tumor Taxonomy (cIMPACT) NOW 6 criteria
- Participants must have confirmed EGFRvIII-expression
- Karnofsky Performance Status (KPS) Score of >=70%.
- Adequate organ functions prior to start of study treatment
- Willingness to abide by contraceptive measures for the duration of the study.
Inclusion criteria for Part I and Part II only:
- Participants whose tumors have an unmethylated O6-methylguanine-DNA methyltransferase (MGMT) promotor status based on local assessment
- Participants must have completed standard of care therapy for newly diagnosed disease, including surgical resection and adjuvant radiotherapy with or without concomitant temozolomide.
Inclusion criteria for Part III and Part IV only:
- Documented first or second recurrence of GBM
- At least one measurable GBM lesion as per RANO criteria prior to initiation of study treatment.
Exclusion criteria for all participants:
- Participants with infratentorial tumors and tumors primarily located in or close to critical structures (e.g., brain stem).
- Presence of extracranial metastatic or leptomeningeal disease
- Known hypersensitivity to immunoglobulins or to any other component of the investigational medicinal product formulation
- Active bleeding or pathological condition that carries a high risk of bleeding, including inherited and acquired coagulopathies
- Participants unable to undergo an MRI with contrast.
Exclusion criteria for Part I and Part II only:
- Recurrent malignant gliomas
- Any prior anti-tumor treatment for GBM: tumor resection, adjuvant radiotherapy with or without concomitant temozolomide must be the only tumor-directed treatment that the participant has received for GBM.
Exclusion criteria for Part III and Part IV only:
- More than two recurrences of GBM
- Prior anti-EGFRvIII-targeting agents (including vaccines), anti-angiogenic therapy, and/ or gene therapy for the treatment of GBM and gliomas.
For the latest version of this information please go to www.forpatients.roche.com