RO7428731 for Glioblastoma

Recruiting in Palo Alto (17 mi)

+14 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Hoffmann-La Roche

No Placebo Group

Trial Summary

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.

Eligibility Criteria

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

At least one measurable GBM lesion as per Response Assessment in Neuro-Oncology (RANO) criteria prior to initiation of study treatment.

Willingness to abide by contraceptive measures for the duration of the study.

My tumor's MGMT status is either unmethylated or methylated.

+8 more

Exclusion Criteria

I do not have any conditions that cause unusual bleeding.

My GBM has recurred more than twice.

My tumor is located in a critical area of the brain.

+6 more

Participant Groups

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.

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.