RO7428731 for Glioblastoma
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new drug, RO7428731, for safety and effectiveness in patients with a specific type of brain cancer (glioblastoma) that has a particular mutation. The drug works by targeting and binding to the mutated cancer cells to stop their growth. This mutation is common in glioblastoma and makes the cancer grow faster and resist standard treatments.
Do I need to stop taking my current medications for the trial?
The trial protocol does not specify whether you need to stop taking your current medications. However, it mentions that participants should not have received certain prior treatments for GBM, so it's best to discuss your current medications with the study team.
What makes the drug RO7428731 unique for treating glioblastoma?
What data supports the effectiveness of the drug RO7428731 for glioblastoma?
The research suggests that combining chemotherapy with radiation, like temozolomide with radiotherapy, improves survival rates in glioblastoma patients, especially those with specific genetic markers. This indicates that targeted therapies, potentially similar to RO7428731, could be effective in treating glioblastoma by improving patient outcomes.36789
Who Is on the Research Team?
Clinical Trials
Principal Investigator
Hoffmann-La Roche
Are You a Good Fit for This Trial?
This trial is for adults with a specific brain cancer called EGFRvIII-positive glioblastoma, either newly diagnosed or recurrent. They should have completed standard treatments and be expected to live at least 12 weeks. Participants need good physical function (KPS Score >=70%) and proper organ function. Those with high bleeding risks, more than two GBM recurrences, certain tumor locations, or previous extensive GBM treatments are excluded.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Safety Run-in
Participants with recurrent GBM receive RO7428731, IV in a dosing schedule determined in Part I
Dose Escalation
Participants with newly diagnosed GBM receive RO7428731, IV, up to one year or until disease progression, withdrawal of consent, unacceptable toxicity, or death
Dose Expansion
Participants with newly diagnosed GBM receive RO7428731, IV in maximum of two dose expansion cohorts at a dose(s) not exceeding the MTD established in Part I
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- RO7428731
Find a Clinic Near You
Who Is Running the Clinical Trial?
Hoffmann-La Roche
Lead Sponsor
Dr. Levi Garraway
Hoffmann-La Roche
Chief Medical Officer since 2019
MD from the University of Basel
Dr. Thomas Schinecker
Hoffmann-La Roche
Chief Executive Officer since 2023
PhD in Molecular Biology from New York University