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Monoclonal Antibodies
RO7428731 for Glioblastoma
Phase 1
Recruiting
Research Sponsored by Hoffmann-La Roche
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Participants whose tumors have an unmethylated (Part I and Part II) or methylated (Part I only) O6-methylguanine-DNA methyltransferase (MGMT) promotor status based on local assessment
Documented first or second recurrence of GBM
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from start of study treatment up to approximately 3 years
Awards & highlights
Study Summary
This trial will test a new drug to treat people with a specific kind of brain tumor. The drug will be given to people who have either just been diagnosed with the tumor or who have had the tumor come back. Researchers will be looking at how well the drug works and if it has any side effects.
Who is the study for?
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.Check my eligibility
What is being tested?
The study tests RO7428731's safety and effectiveness as a solo treatment in those with EGFRvIII-positive glioblastoma. It's an open-label trial meaning everyone knows what treatment they're getting. The drug’s effects on the body (pharmacokinetics), immune response (immunogenicity), how it works against cancer cells (pharmacodynamics), and its initial success in shrinking tumors will be studied.See study design
What are the potential side effects?
While specific side effects of RO7428731 aren't listed here, similar drugs often cause immune reactions, infusion-related discomforts, fatigue, changes in blood counts affecting immunity/clotting/oxygen transport, liver/kidney function alterations and potential allergic responses.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My tumor's MGMT status is either unmethylated or methylated.
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My brain cancer has come back for the first or second time.
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I have a specific type of brain tumor (EGFRvIII-positive GBM) and have finished standard treatment.
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I have been diagnosed with GBM according to the latest WHO standards.
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I am able to care for myself but may not be able to do active work.
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My cancer tests positive for EGFRvIII.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from start of study treatment up to approximately 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from start of study treatment up to approximately 3 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Percentage of Participants with Adverse Events (AEs)
Percentage of Participants with Dose Limiting Toxicities (DLTs)
Secondary outcome measures
Disease Control Rate (DCR)
Duration of Response (DOR)
Objective Response Rate (ORR)
+4 moreTrial Design
4Treatment groups
Experimental Treatment
Group I: Part IV A: Dose-Expansions CohortExperimental Treatment1 Intervention
Participants with recurrent GBM will receive RO7428731, IV at specified doses and dosing schedules.
Group II: Part III: Safety Run-inExperimental Treatment1 Intervention
Participants with recurrent GBM will receive RO7428731, IV in a dosing schedule determined in Part I. At the end of the Safety Run-in period, a decision will be made as to whether to open the Dose-Expansion Cohort Part IVA or open a second Safety Run-in Cohort at a lower dose.
Group III: Part II: Dose-Expansion(s)Experimental Treatment1 Intervention
Participants with newly diagnosed GBM will receive RO7428731, IV, in maximum of two dose expansion cohorts at a dose(s) not exceeding the maximum tolerated dose (MTD) established in Part I.
Group IV: Part I: Dose EscalationExperimental Treatment1 Intervention
Participants with newly diagnosed GBM will receive RO7428731, intravenously (IV), up to one year or until disease progression, withdrawal of consent, unacceptable toxicity, or death, whichever occurs first.
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Who is running the clinical trial?
Hoffmann-La RocheLead Sponsor
2,432 Previous Clinical Trials
1,090,023 Total Patients Enrolled
11 Trials studying Glioblastoma
2,512 Patients Enrolled for Glioblastoma
Clinical TrialsStudy DirectorHoffmann-La Roche
2,201 Previous Clinical Trials
888,740 Total Patients Enrolled
10 Trials studying Glioblastoma
2,004 Patients Enrolled for Glioblastoma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have any conditions that cause unusual bleeding.My GBM has recurred more than twice.My tumor's MGMT status is either unmethylated or methylated.I have a specific type of brain tumor (EGFRvIII-positive GBM) and have finished standard treatment.I have a specific type of brain tumor (EGFRvIII-positive GBM) and have completed standard treatment.My tumor is located in a critical area of the brain.My brain cancer has come back for the first or second time.My cancer has spread outside of my brain.I have been diagnosed with GBM according to the latest WHO standards.I am able to care for myself but may not be able to do active work.My cancer tests positive for EGFRvIII.My brain tumor has come back after treatment.I have only had surgery, radiation, and temozolomide for my GBM.You have a known allergy to immunoglobulins or any other ingredient in the study drug.My organs are functioning well enough to start treatment.I have not received treatments targeting EGFRvIII, anti-angiogenic therapy, or gene therapy for GBM or gliomas.
Research Study Groups:
This trial has the following groups:- Group 1: Part III: Safety Run-in
- Group 2: Part I: Dose Escalation
- Group 3: Part II: Dose-Expansion(s)
- Group 4: Part IV A: Dose-Expansions Cohort
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the current enrollment for this therapeutic experiment?
"Affirmative, according to information on clinicaltrials.gov the trial is still in search of participants. First posted on April 5th 2022 and last updated November 22nd 2022, this study needs 200 volunteers across two medical centres."
Answered by AI
Has the FDA sanctioned RO7428731 for clinical use?
"As this is an early trial, the evidence for RO7428731's efficacy and safety has yet to be confirmed. Consequently, our assessment of its security rating was 1 on a scale from 1-3."
Answered by AI
Are participants being actively sought out for this research endeavor?
"Per the records found on clinicaltrials.gov, this medical research study is actively recruiting volunteers and was first published in April of 2022 with its most recent update being made in November of that same year."
Answered by AI
Who else is applying?
What site did they apply to?
Memorial Sloan Kettering Cancer Center
What portion of applicants met pre-screening criteria?
Met criteria
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