drugset / Trial / NCT02346955
Study of CM-24 (MK-6018) Alone and In Combination With Pembrolizumab (MK-3475) in Participants With Selected Advanced or Recurrent Malignancies (MK-6018-001)
Non-randomizedSingle-groupOpen-labelTreatment
Summary
The purpose of this study is to evaluate the safety and tolerability of humanized IgG4 (kappa) isotype monoclonal antibody against CEACAM1 (CM-24 \[MK-6018\]), administered intravenously as monotherapy and in combination with Pembrolizumab (MK-3475), in participants with selected advanced or recurrent malignancies. Escalating multiple doses will be evaluated to determine the recommended dose for Phase 2 clinical studies.
Timeline
- Start
- 2015-02
- Primary completion
- 2017-02
- Completion
- 2017-02
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | CM-24 | Monoclonal antibody | 0.01 mg/kg | Intravenous |
| Subject | CM-24 | Monoclonal antibody | 0.03 mg/kg | Intravenous |
| Subject | CM-24 | Monoclonal antibody | 0.1 mg/kg | Intravenous |
| Subject | CM-24 | Monoclonal antibody | 0.3 mg/kg | Intravenous |
| Subject | CM-24 | Monoclonal antibody | 1 mg/kg | Intravenous |
| Subject | CM-24 | Monoclonal antibody | 3 mg/kg | Intravenous |
| Subject | CM-24 | Monoclonal antibody | 10 mg/kg | Intravenous |
| Subject | Pembrolizumab | Monoclonal antibody | 200 mg | Intravenous |