drugset / Trial / NCT02350673

A Study of Intravenous (IV) Cergutuzumab Amunaleukin and Atezolizumab in Combination in Participants With Locally Advanced and/or Metastatic Solid Tumors

NCT02350673 ↗

Phase 1 Completed 70 enrolled Hoffmann-La Roche
Non-randomizedSequentialOpen-labelTreatment

Summary

This is an open-label, multi-center, Phase Ib clinical study of cergutuzumab amunaleukin, in combination with atezolizumab, to investigate the safety, pharmacokinetics, and therapeutic activity in participants with locally advanced and/or metastatic carcinoembryonic antigen (CEA)-positive solid tumors, whose disease has progressed on or who are intolerant to the standard of care therapy. Enrolled participants who continue treatment will be treated until loss of clinical benefit, unacceptable toxicities, or withdrawal of consent. The study will include 2 parts: a dose-escalation Part I and a dose expansion Part II. The anticipated treatment period is 24 months for both cergutuzumab amunaleukin and atezolizumab and may be modified if emerging data suggest a benefit.

Timeline

Start
2015-06-29
Primary completion
2019-12-16
Completion
2019-12-16

Drugs

EvaluationDrugModalityDoseRoute
Subject Atezolizumab Monoclonal antibody 800 mg Intravenous
Subject Atezolizumab Monoclonal antibody 840 mg Intravenous
Subject Atezolizumab Monoclonal antibody 1200 mg Intravenous
Subject Cergutuzumab Amunaleukin Protein / enzyme biologic 6 mg Intravenous

Indications