drugset / Trial / NCT03292172
A Study to Evaluate the Safety, Pharmacokinetics and Clinical Activity of RO6870810 and Atezolizumab (PD-L1 Antibody) in Participants With Advanced Ovarian Cancer or Triple Negative Breast Cancer
Non-randomizedSequentialOpen-labelTreatment
Summary
This is Phase IB, open label, non-randomized study designed to investigate the dose, safety, pharmacokinetics and anti-tumor activity of RO6870810 in combination with a fixed dose of atezolizumab. The study consists of four groups, Group 1 (Dose Escalation Group) and Group 2 (Sequential Dose Group), and Groups 3 and 4 (Expansion Groups), which will further evaluate the safety, pharmacokinetic, pharmacodynamic and preliminary clinical activity in patients with triple negaive breast cancer and/or ovarian cancer.
Timeline
- Start
- 2017-11-08
- Primary completion
- 2019-02-26
- Completion
- 2019-02-26
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Atezolizumab | Monoclonal antibody | 1200 mg | Intravenous |
| Subject | RO6870810 | Small molecule | 0.3 mg/kg | Subcutaneous |
| Subject | RO6870810 | Small molecule | 0.45 mg/kg | Subcutaneous |
| Subject | RO6870810 | Small molecule | 0.65 mg/kg | Subcutaneous |