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

NCT03292172

Phase 1 Terminated 36 enrolled Hoffmann-La Roche
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

EvaluationDrugModalityDoseRoute
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