drugset / Trial / NCT02444793
A Study of PF-05082566 In Combination With Mogamulizumab In Patients With Advanced Solid Tumors
Open-labelTreatment
Summary
This study is a Phase 1b, open label, multi center, multi-dose trial designed to estimate the maximum tolerated dose (MTD) and select the recommended dose for phase 2 (RP2D) investigations of PF- 05082566 in combination with KW-0761 (mogamulizumab) in patients with advanced solid tumors. Once the MTD of PF-05082566 administered in combination with KW-0761 is estimated (dose finding), one or more expansion cohorts of patients with selected advanced solid tumors (dose-expansion ) will be enrolled to further characterize the combination in term of safety profile, anti tumor activity, pharmacokinetics, pharmacodynamics and biomarkers modulation.
Timeline
- Start
- 2015-05
- Primary completion
- 2017-09
- Completion
- 2017-10
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Mogamulizumab | Monoclonal antibody | 1 mg/kg | Intravenous |
| Subject | Utomilumab | Monoclonal antibody | 1.2 mg/kg | Intravenous |
| Subject | Utomilumab | Monoclonal antibody | 5 mg/kg | Intravenous |
| Subject | Utomilumab | Monoclonal antibody | 100 mg | Intravenous |
Indications
No indication recorded.