drugset / Trial / NCT03219268

A Study of MGD013 in Patients With Unresectable or Metastatic Neoplasms

NCT03219268

Phase 1 Completed 277 enrolled MacroGenics
Non-randomizedSequentialOpen-labelTreatment

Summary

The primary goal of this Phase 1 study is to characterize the safety and tolerability of tebotelimab and establish the maximum tolerated dose (MTD) of tebotelimab in advanced solid tumors, and tebotelimab in combination with margetuximab in HER2+ advanced solid tumors. Pharmacokinetics (PK), immunogenicity, pharmacodynamics (PD), and the anti-tumor activity of tebotelimab will also be assessed.

Timeline

Start
2017-08-18
Primary completion
2023-02-08
Completion
2023-02-08

Drugs

EvaluationDrugModalityDoseRoute
Subject Margetuximab Monoclonal antibody 15 mg/kg Intravenous
Subject Tebotelimab Protein / enzyme biologic 1 mg Intravenous
Subject Tebotelimab Protein / enzyme biologic 3 mg Intravenous
Subject Tebotelimab Protein / enzyme biologic 10 mg Intravenous
Subject Tebotelimab Protein / enzyme biologic 30 mg Intravenous
Subject Tebotelimab Protein / enzyme biologic 120 mg Intravenous
Subject Tebotelimab Protein / enzyme biologic 300 mg Intravenous
Subject Tebotelimab Protein / enzyme biologic 400 mg Intravenous
Subject Tebotelimab Protein / enzyme biologic 600 mg Intravenous
Subject Tebotelimab Protein / enzyme biologic 800 mg Intravenous
Subject Tebotelimab Protein / enzyme biologic 1200 mg Intravenous