RO7428731 for Glioblastoma
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to test a new treatment, RO7428731, for glioblastoma, an aggressive brain cancer positive for the EGFRvIII protein variant. Researchers seek to determine the safety and tolerability of this treatment and its potential to manage the condition. The study includes different parts, testing RO7428731 on individuals with either newly diagnosed or recurrent forms of the disease. Suitable candidates have glioblastoma expressing EGFRvIII and have either just been diagnosed or experienced a recurrence once or twice. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.
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.
Is there any evidence suggesting that RO7428731 is likely to be safe for humans?
Current research is investigating the safety and tolerability of RO7428731 for people with glioblastoma, a type of brain cancer. The studies test different doses to find the safest and most effective amount for patients. As this is an early-stage trial, the primary goal is to identify any side effects and understand how the body processes the treatment. While detailed safety information is not yet available, the trial focuses on assessing treatment tolerability. Researchers closely monitor for any negative effects as they work to determine the safest dose.12345
Why do researchers think this study treatment might be promising for glioblastoma?
Most treatments for glioblastoma, like temozolomide and radiation therapy, focus on disrupting cancer cell growth. But RO7428731 works differently, targeting specific pathways involved in tumor survival and growth, potentially offering a new approach to combat this aggressive cancer. Researchers are excited because this drug is administered intravenously, which may lead to more precise dosing and potentially fewer side effects. Additionally, it could provide an option for patients with recurrent glioblastoma, a group that often has fewer effective treatment choices.
What evidence suggests that RO7428731 might be an effective treatment for glioblastoma?
Research has shown that RO7428731 is a new treatment being tested for glioblastoma, a challenging brain cancer. The trial includes different parts where participants with either newly diagnosed or recurrent glioblastoma receive RO7428731. This drug targets a specific form of a protein called EGFRvIII, often found in glioblastoma cells. Early results suggest that focusing on this protein might help slow or stop tumor growth. Although strong evidence about its effectiveness in humans is not yet available, this method is promising because it aims to directly inhibit cancer cell growth. More research is needed to determine how well RO7428731 works for people with glioblastoma.24567
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