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RO7428731 · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Part I: Dose Escalation | EXPERIMENTAL | 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. |
| Part II: Dose-Expansion(s) | EXPERIMENTAL | 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. |
| Part III: Safety Run-in | EXPERIMENTAL | 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. |
| Part IV A: Dose-Expansions Cohort | EXPERIMENTAL | Participants with recurrent GBM will receive RO7428731, IV at specified doses and dosing schedules. |
| Name | Type | Description |
|---|---|---|
| RO7428731 | DRUG | Participants will receive RO7428731 as described. |
Inclusion Criteria: Inclusion criteria for all participants: * Life expectancy of greater than or equal to 12 weeks, in the opinion of the Investigator * Diagnosis of GBM based on World Health Organization (WHO) classification of central nervous system (CNS) tumors, 5th edition * Participants must...
RO7428731 is an investigational small molecule being studied for the treatment of glioblastoma, a type of brain cancer. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities. The drug is being evaluated for its safety, pharmacokinetics, and anti-tumor activity in adult patients with glioblastoma.
RO7428731 is being developed by Roche Holding AG, a multinational healthcare company. Roche's stock is traded under the ticker symbol RHHBY on the OTC market. The company is conducting clinical trials to evaluate the drug's potential as a treatment for glioblastoma.
RO7428731 is in Phase 1 clinical development. A Phase 1 study has been completed, which focused on evaluating the safety, pharmacokinetics, and anti-tumor activity of the drug in participants with glioblastoma. The drug is still investigational and has not received FDA approval.
RO7428731 has one completed clinical trial registered under NCT05187624. This Phase 1 study evaluated the safety, pharmacokinetic, and anti-tumor activity of RO7428731 in participants with glioblastoma. The trial enrolled 36 participants across the United States, Australia, Canada, Denmark, and Spain.
RO7428731 is not FDA approved. It is an investigational drug currently in Phase 1 clinical development for the treatment of glioblastoma. A Phase 1 study has been completed, but the drug has not yet received regulatory approval for any indication.
RO7428731 is a small molecule being developed for the treatment of glioblastoma. The specific molecular target of this drug has not been disclosed in available information. It is currently in Phase 1 clinical trials to evaluate its safety and anti-tumor activity in patients with glioblastoma.