Trials / Completed
CompletedNCT05187624
A Study Evaluating the Safety, Pharmacokinetic and Anti-tumor Activity of RO7428731 in Participants With Glioblastoma
An Open-label, Multicenter, Phase I Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Clinical Activity of RO7428731 in Participants With Glioblastoma Expressing Mutant Epidermal Growth Factor Receptor Variant III
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 36 (actual)
- Sponsor
- Hoffmann-La Roche · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This is an open-label, multicenter study to assess safety, tolerability, pharmacokinetics (PK), immunogenicity, pharmacodynamics (PD), and preliminary efficacy of RO7428731 administered as a monotherapy in participants with newly diagnosed or recurrent epidermal growth factor receptor variant III (EGFRvIII)-positive glioblastoma (GBM).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | RO7428731 | Participants will receive RO7428731 as described. |
Timeline
- Start date
- 2022-04-05
- Primary completion
- 2025-05-14
- Completion
- 2025-05-14
- First posted
- 2022-01-12
- Last updated
- 2025-05-22
Locations
8 sites across 5 countries: United States, Australia, Canada, Denmark, Spain
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05187624. Inclusion in this directory is not an endorsement.