drugset / Trial / NCT02141347
Ph1 to Assess Safety, Tolerability of Tremelimumab/ Tremelimumab+MEDI4736 in Japanese Solid Malignancies/ Mesothelioma
Non-randomizedOpen-labelOther
Summary
A Phase I, Open-Label, Multicentre Study to Assess the Safety, Tolerability, PK and Preliminary Anti-tumor Activity when given as a monotherapy of Tremelimumab or Tremelimumab in combination with MEDI4736 in Japanese Patients with Advanced Solid Malignancies, and when given as a monotherapy of tremelimumab in Second- or Third-line Treatment of Japanese Subjects with Unresectable Pleural or Peritoneal Malignant Mesothelioma
Timeline
- Start
- 2014-05-22
- Primary completion
- 2017-01-27
- Completion
- 2017-01-27
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Durvalumab | Monoclonal antibody | 10 mg/kg | Intravenous |
| Subject | Durvalumab | Monoclonal antibody | 15 mg/kg | Intravenous |
| Subject | Durvalumab | Monoclonal antibody | 1500 mg | Intravenous |
| Subject | Tremelimumab | Monoclonal antibody | 1 mg/kg | Intravenous |
| Subject | Tremelimumab | Monoclonal antibody | 3 mg/kg | Intravenous |
| Subject | Tremelimumab | Monoclonal antibody | 10 mg/kg | Intravenous |
| Subject | Tremelimumab | Monoclonal antibody | 75 mg | Intravenous |