NCT02410512

A Study to Assess the Safety and Pharmacokinetics of MOXR0916 and Atezolizumab (Also Known as MPDL3280A or Anti-PD-L1) in Participants With Locally Advanced or Metastatic Solid Tumors

A Phase Ib, Open-Label, Dose-Escalation Study of the Safety and Pharmacokinetics of MOXR0916 and Atezolizumab in Patients With Locally Advanced or Metastatic Solid Tumors

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 610 (actual)
• Sponsor: Genentech, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This Phase Ib, open-label, dose-escalation study will evaluate the safety, tolerability, and pharmacokinetics of the combination of MOXR0916 and atezolizumab in participants with locally advanced, recurrent, or metastatic incurable solid malignancy that has progressed after available standard therapy; or for which standard therapy has proven to be ineffective or intolerable or is considered inappropriate; or for which a clinical trial of an investigational agent is a recognized standard of care. Participants will be enrolled in two stages: a dose-escalation stage and an expansion stage.

Conditions

• Neoplasms

Interventions

Type	Name	Description
DRUG	Atezolizumab (MPDL3280A), an engineered anti-programmed death-ligand 1 [PD-L1] antibody	Atezolizumab will be administered intravenously.
DRUG	MOXR0916, a humanized agonist anti-OX40 monoclonal antibody	MOXR0916 will be administered intravenously.

Timeline

• Start date: 2015-04-24
• Primary completion: 2019-11-22
• Completion: 2019-11-22
• First posted: 2015-04-07
• Last updated: 2022-04-01

Locations

27 sites across 7 countries: United States, Australia, Belgium, Canada, France, South Korea, Spain