BP42573 - A Study of RO7428731 In Participants with Glioblastoma

• Research type

  Research Study

• Full title

  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

• IRAS ID

  1007196

• Contact name

  Ethan Montenegro

• Contact email

  uk.dra@roche.com

• Sponsor organisation

  F. Hoffmann-La Roche Ltd

• Eudract number

  2021-001197-37

• Research summary

  Glioblastoma (GBM) is the most common and aggressive primary brain tumour, accounting for
  50% to 60% of all malignant gliomas. Despite standard first-line treatment with neurosurgery,
  radiation therapy and temozolomide (TMZ), median overall survival (OS) is approximately
  12 to15 months, and only 3% to 10% of patients survive greater than 5 years.
  As a tumour specific protein, EGFRvIII represents an ideal target for targeted cancer immunotherapies
  such as T-cell bispecific antibodies.

  The aim of the study is to assess the safety, tolerability, PK,
  immunogenicity, PD, and preliminary efficacy of RO7428731, and the
  selection of an optimal dose and treatment schedule for further development.

  Part I dose-escalation will enrol multiple participant cohorts with IV RO7428731 administered on day (D) 1 of every 3-week cycle (C). Part II Dose-Expansion has been designed to explore the safety and preliminary clinical activity of RO7428731 and to define the recommended Phase 2 dose (RP2D) of RO7428731 monotherapy. Part III (Safety Run-in) aims to confirm the safety and tolerability of the RDE of IV RO7428731 monotherapy and the dosing schedule determined from Part I in participants with recurrent GBM. .
  Part IVA (Dose-Expansion Cohort) will explore the safety as well as preliminary clinical activity of RO7428731 monotherapy in participants with recurrent GBM and will enroll up to approximately 40 participants per cohort. Part IVB (Biomarker-Expansion Cohort) will enroll participants requiring salvage surgery to treat relapsed disease

  Approximately 200 participants are expected to complete the study (not including the participants from the Biomarker Cohort Part IVB).
  There will be approximately 15 patients recruited at 1 UK site.

• REC name

  South Central - Berkshire Research Ethics Committee

• REC reference

  23/SC/0131

• Date of REC Opinion

  25 Jul 2023

• REC opinion

  Further Information Favourable Opinion