drugset / Trial / NCT02132754
Study of MK-4166 and MK-4166 in Combination With Pembrolizumab (MK-3475) in Participants With Advanced Solid Tumors (MK-4166-001)
Non-randomizedParallel-groupOpen-labelTreatment
Summary
This is planned to be a 5-part dose-escalation study to determine the safety and tolerability of MK-4166 monotherapy and MK-4166 plus pembrolizumab combination therapy, and to establish the maximum tolerated dose (MTD) or maximum administered dose (MAD) of MK-4166 and MK-4166 plus pembrolizumab by defining dose-limiting toxicities (DLTs) in participants with advanced solid tumors.
Timeline
- Start
- 2014-06-27
- Primary completion
- 2019-07-31
- Completion
- 2019-07-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | MK-4166 | Monoclonal antibody | 0.0015 mg | Intravenous |
| Subject | MK-4166 | Monoclonal antibody | 0.0045 mg | Intravenous |
| Subject | MK-4166 | Monoclonal antibody | 0.014 mg | Intravenous |
| Subject | MK-4166 | Monoclonal antibody | 0.04 mg | Intravenous |
| Subject | MK-4166 | Monoclonal antibody | 0.12 mg | Intravenous |
| Subject | MK-4166 | Monoclonal antibody | 0.37 mg | Intravenous |
| Subject | MK-4166 | Monoclonal antibody | 1.1 mg | Intravenous |
| Subject | MK-4166 | Monoclonal antibody | 3.3 mg | Intravenous |
| Subject | MK-4166 | Monoclonal antibody | 10 mg | Intravenous |
| Subject | MK-4166 | Monoclonal antibody | 30 mg | Intravenous |
| Subject | MK-4166 | Monoclonal antibody | 42 mg | Intravenous |
| Subject | MK-4166 | Monoclonal antibody | 59 mg | Intravenous |
| Subject | MK-4166 | Monoclonal antibody | 82 mg | Intravenous |
| Subject | MK-4166 | Monoclonal antibody | 120 mg | Intravenous |
| Subject | MK-4166 | Monoclonal antibody | 170 mg | Intravenous |
| Subject | MK-4166 | Monoclonal antibody | 240 mg | Intravenous |
| Subject | MK-4166 | Monoclonal antibody | 340 mg | Intravenous |
| Subject | MK-4166 | Monoclonal antibody | 480 mg | Intravenous |
| Subject | MK-4166 | Monoclonal antibody | 670 mg | Intravenous |
| Subject | MK-4166 | Monoclonal antibody | 900 mg | Intravenous |
| Subject | Pembrolizumab | Monoclonal antibody | 200 mg | Intravenous |