Trials / Completed
CompletedNCT03289962
A Study of Autogene Cevumeran (RO7198457) as a Single Agent and in Combination With Atezolizumab in Participants With Locally Advanced or Metastatic Tumors
A Phase 1a/1b Open-Label, Dose-Escalation Study of the Safety and Pharmacokinetics of RO7198457 as a Single Agent and in Combination With Atezolizumab in Patients With Locally Advanced or Metastatic Tumors
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 272 (actual)
- Sponsor
- Genentech, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This is a Phase 1a/1b, open-label, multicenter, global, dose-escalation study designed to evaluate the safety, tolerability, immune response, and pharmacokinetics of autogene cevumeran (RO7198457) as a single agent and in combination with atezolizumab (MPDL3280A, an engineered anti-programmed death-ligand 1 \[anti-PD-L1\] antibody).
Conditions
- Melanoma
- Non-Small Cell Lung Cancer
- Bladder Cancer
- Colorectal Cancer
- Triple Negative Breast Cancer
- Renal Cancer
- Head and Neck Cancer
- Other Solid Cancers
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Autogene cevumeran | Autogene cevumeran will be administered by intravenous (IV) infusion, in 21-day cycles. |
| DRUG | Atezolizumab | Atezolizumab will be administered by IV infusion on Day 1 of every 21-day cycle. |
Timeline
- Start date
- 2017-12-21
- Primary completion
- 2025-07-01
- Completion
- 2025-07-01
- First posted
- 2017-09-21
- Last updated
- 2025-07-04
Locations
26 sites across 8 countries: United States, Belgium, Canada, Germany, Netherlands, Spain, Sweden, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03289962. Inclusion in this directory is not an endorsement.