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Monoclonal Antibodies

RO7428731 for Glioblastoma

Phase 1
Waitlist Available
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
Must not have
Active bleeding or pathological condition that carries a high risk of bleeding, including inherited and acquired coagulopathies
More than two recurrences of GBM
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from start of study treatment up to approximately 3 years
Awards & highlights

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 below
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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I do not have any conditions that cause unusual bleeding.
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My GBM has recurred more than twice.
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My tumor is located in a critical area of the brain.
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My cancer has spread outside of my brain.
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My brain tumor has come back after treatment.
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I have only had surgery, radiation, and temozolomide for my GBM.
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I have not received treatments targeting EGFRvIII, anti-angiogenic therapy, or gene therapy for GBM or gliomas.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from start of study treatment up to approximately 3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and from start of study treatment up to approximately 3 years for reporting.

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 more

Trial 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.

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Glioblastoma treatments often target the Epidermal Growth Factor Receptor variant III (EGFRvIII), a mutation commonly found in these tumors. EGFRvIII inhibitors, like RO7428731, work by blocking the signaling pathways that promote tumor growth and survival, which is crucial for slowing disease progression. Additionally, standard treatments include temozolomide, an oral chemotherapy that damages the DNA of cancer cells, and radiation therapy, which uses high-energy rays to kill or damage cancer cells. These treatments aim to control tumor growth, alleviate symptoms, and extend survival, addressing the aggressive nature of Glioblastoma.

Find a Location

Who is running the clinical trial?

Hoffmann-La RocheLead Sponsor
2,436 Previous Clinical Trials
1,091,435 Total Patients Enrolled
11 Trials studying Glioblastoma
2,512 Patients Enrolled for Glioblastoma
Clinical TrialsStudy DirectorHoffmann-La Roche
2,204 Previous Clinical Trials
890,106 Total Patients Enrolled
10 Trials studying Glioblastoma
2,004 Patients Enrolled for Glioblastoma

Media Library

RO7428731 (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05187624 — Phase 1
Glioblastoma Research Study Groups: Part III: Safety Run-in, Part I: Dose Escalation, Part II: Dose-Expansion(s), Part IV A: Dose-Expansions Cohort
Glioblastoma Clinical Trial 2023: RO7428731 Highlights & Side Effects. Trial Name: NCT05187624 — Phase 1
RO7428731 (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05187624 — Phase 1
~77 spots leftby Dec 2025