drugset / Trial / NCT03219268
A Study of MGD013 in Patients With Unresectable or Metastatic Neoplasms
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| 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 |